CClinicalTrials.gg
CompletedNCT00700817Updated Mar 8, 2017Results posted

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

A Phase 3 interventional study of liraglutide and sitagliptin in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 166 sites in 15 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-08.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
665
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

  1. Week 27-52 after randomisation

    • All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
  2. Week 53-78 after randomisation

    • Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
    • Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.
02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 665 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes
  • Treatment with metformin alone for at least three months
  • HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
  • Body Mass Index (BMI) less than or equal to 45.0

Exclusion criteria

Exclusion Criteria:

  • Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
  • Treatment with anti-diabetic drugs other than metformin within the last three months
  • Any serious medical condition
  • Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
665 participants (actual)

Study arms

  • Experimental
    Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg

    Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).

    Drug: liraglutide · Drug: metformin

  • Experimental
    Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg

    Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).

    Drug: metformin · Drug: liraglutide

  • Active comparator
    Sita -> Sita

    Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).

    Drug: sitagliptin · Drug: metformin

  • Experimental
    Sita -> Sita -> Lira 1.2 mg

    Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.

    Drug: liraglutide · Drug: sitagliptin · Drug: metformin

  • Experimental
    Sita -> Sita -> Lira 1.8 mg

    Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.

    Drug: sitagliptin · Drug: metformin · Drug: liraglutide

Interventions

  • Drugliraglutide

    1.2 mg once daily, subcutaneous (under the skin) injection

  • Drugsitagliptin

    Tablets, 100 mg daily

  • Drugmetformin

    Tablets, minimum 1500 mg daily

  • Drugliraglutide

    1.8 mg once daily, subcutaneous (under the skin) injection

06

What researchers measure

Primary outcomes

  1. Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

    Time frame: Week 0, Week 26

  2. Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.

    Time frame: Week 0, Week 52

  3. Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78

    Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.

    Time frame: Week 0, Week 78

  4. Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78

    Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78

    Time frame: Week 52, Week 78

Secondary outcomes

  1. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26

    Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26

    Time frame: Week 0, Week 26

  2. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 52

    Time frame: Week 0, Week 52

  3. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the FAS.

    Time frame: Week 0, Week 78

  4. Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the extension 2 FAS.

    Time frame: Week 0, Week 78

  5. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26

    Calculated as the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 26

    Time frame: Week 0, Week 26

  6. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 52

    Time frame: Week 0, Week 52

  7. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the FAS.

    Time frame: Week 0, Week 78

  8. Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

    Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the extension 2 FAS.

    Time frame: Week 0, Week 78

  9. Mean Change From Baseline in Body Weight at Week 26

    Calculated as an estimate of the mean change from baseline in body weight at Week 26.

    Time frame: Week 0, Week 26

  10. Mean Change From Baseline in Body Weight at Week 52

    Calculated as an estimate of the mean change from baseline in body weight at Week 52.

    Time frame: Week 0, Week 52

  11. Mean Change in Body Weight From Week 52 to Week 78

    Mean change in body weight from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  12. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

    Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.

    Time frame: Week 0, Week 26

  13. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

    Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.

    Time frame: Week 0, Week 52

  14. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78

    Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.

    Time frame: Week 0, Week 78

  15. Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78

    Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.

    Time frame: Week 52, Week 78

  16. Mean Change From Baseline in Beta-cell Function at Week 26

    Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

    Time frame: Week 0, Week 26

  17. Mean Change From Baseline in Beta-cell Function at Week 52

    Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

    Time frame: Week 0, Week 52

  18. Mean Change in Beta-cell Function From Week 52 to Week 78

    Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

    Time frame: Week 52, Week 78

  19. Mean Change From Baseline in Total Cholesterol at Week 26

    Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.

    Time frame: Week 0, Week 26

  20. Mean Change From Baseline in Total Cholesterol at Week 52

    Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.

    Time frame: Week 0, Week 52

  21. Mean Change in Total Cholesterol From Week 52 to Week 78

    Mean change in total cholesterol from Week 52 to Week 78

    Time frame: Week 52, Week 78

  22. Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26

    Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.

    Time frame: Week 0, Week 26

  23. Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52

    Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.

    Time frame: Week 0, Week 52

  24. Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78

    Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.

    Time frame: Week 52, Week 78

  25. Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26

    Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.

    Time frame: Week 0, Week 26

  26. Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52

    Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.

    Time frame: Week 0, Week 52

  27. Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78

    Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  28. Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26

    Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.

    Time frame: Week 0, Week 26

  29. Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52

    Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.

    Time frame: Week 0, Week 52

  30. Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78

    Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  31. Mean Change From Baseline in Triglycerides (TG) at Week 26

    Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.

    Time frame: Week 0, Week 26

  32. Mean Change From Baseline in Triglycerides (TG) at Week 52

    Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.

    Time frame: Week 0, Week 52

  33. Mean Change in Triglycerides (TG) From Week 52 to Week 78

    Mean change in triglycerides (TG) from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  34. Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26

    Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.

    Time frame: Week 0, Week 26

  35. Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52

    Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.

    Time frame: Week 0, Week 52

  36. Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78

    Mean change in free fatty acids (FFA) from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  37. Mean Change From Baseline in Apolipoprotein B at Week 26

    Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.

    Time frame: Week 0, Week 26

  38. Mean Change From Baseline in Apolipoprotein B at Week 52

    Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.

    Time frame: Week 0, Week 52

  39. Mean Change in Apolipoprotein B From Week 52 to Week 78

    Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  40. Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26

    Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.

    Time frame: Week 0, Week 26

  41. Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.

    Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.

    Time frame: Week 0, Week 26

  42. Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.

    Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.

    Time frame: Week 0, Week 26

  43. Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

    Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

    Time frame: Week 0, Week 26

  44. Mean Change From Baseline in Adiponectin at Week 26.

    Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.

    Time frame: Week 0, Week 26

  45. Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

    Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

    Time frame: Week 0, Week 26

  46. Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.

    Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.

    Time frame: Week 0, Week 26

  47. Mean Change From Baseline in Waist to Hip Ratio at Week 26.

    Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

    Time frame: Week 0, Week 26

  48. Mean Change From Baseline in Waist to Hip Ratio at Week 52

    Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

    Time frame: Week 0, Week 52

  49. Mean Change in Waist to Hip Ratio From Week 52 to Week 78

    Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

    Time frame: Week 52, Week 78

  50. Mean Change From Baseline in Waist Circumference at Week 26.

    Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26

    Time frame: Week 0, Week 26

  51. Mean Change From Baseline in Waist Circumference at Week 52

    Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.

    Time frame: Week 0, Week 52

  52. Mean Change in Waist Circumference From Week 52 to Week 78

    Mean change in Waist Circumference from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  53. Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

    Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26

    Time frame: Week 0, Week 26

  54. Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

    Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.

    Time frame: Week 0, Week 52

  55. Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78

    Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  56. Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

    Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.

    Time frame: Week 0, Week 26

  57. Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52

    Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.

    Time frame: Week 0, Week 52

  58. Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78

    Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  59. Mean Change From Baseline in Pulse at Week 26

    Calculated as an estimate of the mean change from baseline in pulse at Week 26.

    Time frame: Week 0, Week 26

  60. Mean Change From Baseline in Pulse at Week 52

    Calculated as an estimate of the mean change from baseline in pulse at Week 52.

    Time frame: Week 0, Week 52

  61. Mean Change in Pulse From Week 52 to Week 78

    Mean change in pulse from Week 52 to Week 78.

    Time frame: Week 52, Week 78

  62. Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26

    The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

    Time frame: Week 0, Week 26

  63. Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52

    The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

    Time frame: Week 0, Week 52

  64. Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78

    The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

    Time frame: Week 52, Week 78

  65. Hypoglyceamic Episodes, Weeks 0-26

    Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

    Time frame: Weeks 0-26

  66. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

    Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

    Time frame: Weeks 0-26

  67. Hypoglyceamic Episodes, Weeks 0-52

    Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

    Time frame: Weeks 0-52

  68. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52

    Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

    Time frame: Weeks 0-52

  69. Hypoglyceamic Episodes, Weeks 0-78

    Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

    Time frame: Weeks 0-78

  70. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78

    Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

    Time frame: Weeks 0-78

  71. Hypoglycaamic Episodes, Weeks 52-78

    Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

    Time frame: Week 52-78

07

Results

Posted Aug 4, 2010

Participant flow

A total of 158 centres in 13 countries participated: Canada (11), Croatia (3), Germany (12), Ireland (5), Italy (8), Netherlands (8), Romania (4), Serbia (3), Slovakia (6), Slovenia (3), Spain (9), United Kingdom (20) and United States (66). Of the 158 sites approved by an Independent Ethics Committee, 151 actively screened and enrolled subjects.

Week 0-26 (Main Period)
Participant flow — Week 0-26 (Main Period)
MilestoneLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Started22522121900
Exposed22121821900
Completed16919119400
Not completed56302500
Withdrew: Adverse event1415400
Withdrew: Lack of efficacy40400
Withdrew: Protocol violation144400
Withdrew: Withdrawal criteria107500
Withdrew: Unclassified144800
Week 26-52 (Extension Period 1)
Participant flow — Week 26-52 (Extension Period 1)
MilestoneLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Started15517616600
Completed13515015100
Not completed20261500
Withdrew: Adverse event510300
Withdrew: Protocol violation32200
Withdrew: Lack of efficacy23700
Withdrew: Withdrawal criteria68200
Withdrew: Unclassified43100
Week 52-78 (Extension Period 2)
Participant flow — Week 52-78 (Extension Period 2)
MilestoneLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Started13415006768
Completed12413505963
Not completed1015085
Withdrew: Adverse event03060
Withdrew: Protocol violation12011
Withdrew: Lack of efficacy33000
Withdrew: Withdrawal criteria43013
Withdrew: Unclassified24001

Outcome measures

PrimaryMean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · Percentage point of total HbA1c
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Percentage point of total HbA1cLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26-1.24 ± 0.07-1.5 ± 0.06-0.9 ± 0.07——
Statistical analysis
  • Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg vs Sita -> Sita · ANCOVA · p = 0.0001 (Multiple comparisons not applicable due to the hieracheal testing.) · Estimated treatment difference, ls mean: -0.6 · 95% CI -0.77 to -0.43Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
  • Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg vs Sita -> Sita · ANCOVA · p = 0.0001 (Multiple comparisons not applicable due to the hieracheal testing.) · Estimated treatment difference, ls mean: -0.34 · 95% CI -0.51 to -0.16Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
PrimaryMean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · Percentage point of total HbA1c
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Percentage point of total HbA1cLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52-1.29 ± 0.07-1.51 ± 0.07-0.88 ± 0.07——
Statistical analysis
  • Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg vs Sita -> Sita · ANCOVA · p = 0.0001 (Multiple comparisons not applicable due to the hieracheal testing.) · Estimated treatment difference, ls mean: -0.63 · 95% CI -0.81 to -0.44Lira 1.8 - Sita
  • Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg vs Sita -> Sita · ANCOVA · p = 0.0001 (Multiple comparisons not applicable due to the hieracheal testing.) · Estimated treatment difference, ls mean: -0.40 · 95% CI -0.59 to -0.22Lira 1.2 - Sita
PrimaryMean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.

Time frame:
Week 0, Week 78
Reported as:
Least squares mean · Percentage point of total HbA1c
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Percentage point of total HbA1cLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78-0.94 ± 0.08-1.28 ± 0.07———
PrimaryMean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78

Time frame:
Week 52, Week 78
Reported as:
Mean · Percentage point of total HbA1c
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Percentage point of total HbA1cLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78———-0.24 ± 0.7-0.45 ± 0.9
Statistical analysis
  • Sita -> Sita -> Lira 1.2 mg · paired t-test · p = 0.0060 (Multiple comparisons is not applicable.) · Change within treatment group: -0.24 · 95% CI -0.41 to -0.07The analysis is not a controlled comparison, and there are no adjustments
  • Sita -> Sita -> Lira 1.8 mg · paired t-test · p = 0.0001 (Multiple comparisons is not applicable.) · Change within treatment group: -0.45 · 95% CI -0.67 to -0.23The analysis is not a controlled comparison, and there are no adjustments
SecondaryPercentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26

Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26

Time frame:
Week 0, Week 26
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
percentage of subjectsLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26435522——
SecondaryPercentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 52

Time frame:
Week 0, Week 52
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
percentage of subjectsLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52506327——
SecondaryPercentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the FAS.

Time frame:
Week 0, Week 78
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
percentage of subjectsLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 783551———
SecondaryPercentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the extension 2 FAS.

Time frame:
Week 0, Week 78
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
percentage of subjectsLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78———4950
SecondaryPercentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26

Calculated as the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 26

Time frame:
Week 0, Week 26
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
percentage of subjectsLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26233612——
SecondaryPercentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 52

Time frame:
Week 0, Week 52
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
percentage of subjectsLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52244017——
SecondaryPercentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the FAS.

Time frame:
Week 0, Week 78
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
percentage of subjectsLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 781227———
SecondaryPercentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the extension 2 FAS.

Time frame:
Week 0, Week 78
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
percentage of subjectsLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78———2925
SecondaryMean Change From Baseline in Body Weight at Week 26

Calculated as an estimate of the mean change from baseline in body weight at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · kg
Mean Change From Baseline in Body Weight at Week 26
kgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Body Weight at Week 26-2.86 ± 0.27-3.38 ± 0.27-0.96 ± 0.27——
SecondaryMean Change From Baseline in Body Weight at Week 52

Calculated as an estimate of the mean change from baseline in body weight at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · kg
Mean Change From Baseline in Body Weight at Week 52
kgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Body Weight at Week 52-2.78 ± 0.31-3.68 ± 0.31-1.16 ± 0.31——
SecondaryMean Change in Body Weight From Week 52 to Week 78

Mean change in body weight from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · kg
Mean Change in Body Weight From Week 52 to Week 78
kgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Body Weight From Week 52 to Week 78———-1.64 ± 3-2.48 ± 3.6
SecondaryMean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26-1.87 ± 0.15-2.14 ± 0.15-0.83 ± 0.15——
SecondaryMean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52-1.71 ± 0.17-2.04 ± 0.17-0.59 ± 0.17——
SecondaryMean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78

Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.

Time frame:
Week 0, Week 78
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78-1.30 ± 0.18-1.65 ± 0.18———
SecondaryMean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78

Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · mmol/L
Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78———-0.84 ± 1.8-1.42 ± 2.1
SecondaryMean Change From Baseline in Beta-cell Function at Week 26

Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · percentage point
Mean Change From Baseline in Beta-cell Function at Week 26
percentage pointLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Beta-cell Function at Week 2627.23 ± 3.8228.70 ± 3.754.18 ± 3.79——
SecondaryMean Change From Baseline in Beta-cell Function at Week 52

Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · percentage point
Mean Change From Baseline in Beta-cell Function at Week 52
percentage pointLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Beta-cell Function at Week 5222.58 ± 3.3125.76 ± 3.253.98 ± 3.30——
SecondaryMean Change in Beta-cell Function From Week 52 to Week 78

Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Time frame:
Week 52, Week 78
Reported as:
Mean · percentage point
Mean Change in Beta-cell Function From Week 52 to Week 78
percentage pointLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Beta-cell Function From Week 52 to Week 78———13.31 ± 29.423.09 ± 43.7
SecondaryMean Change From Baseline in Total Cholesterol at Week 26

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Total Cholesterol at Week 26
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Total Cholesterol at Week 26-0.03 ± 0.06-0.17 ± 0.05-0.02 ± 0.05——
SecondaryMean Change From Baseline in Total Cholesterol at Week 52

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Total Cholesterol at Week 52
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Total Cholesterol at Week 52-0.01 ± 0.06-0.09 ± 0.060.03 ± 0.06——
SecondaryMean Change in Total Cholesterol From Week 52 to Week 78

Mean change in total cholesterol from Week 52 to Week 78

Time frame:
Week 52, Week 78
Reported as:
Mean · mmol/L
Mean Change in Total Cholesterol From Week 52 to Week 78
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Total Cholesterol From Week 52 to Week 78———-0.16 ± 0.8-0.24 ± 0.7
SecondaryMean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 260.08 ± 0.050.05 ± 0.050.13 ± 0.05——
SecondaryMean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 520.09 ± 0.050.09 ± 0.050.17 ± 0.05——
SecondaryMean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78

Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · mmol/L
Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78———-0.22 ± 0.7-0.25 ± 0.6
SecondaryMean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 260.00 ± 0.010.00 ± 0.010.00 ± 0.01——
SecondaryMean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 520.01 ± 0.010.02 ± 0.010.01 ± 0.01——
SecondaryMean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78

Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · mmol/L
Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78———0.02 ± 0.1-0.01 ± 0.2
SecondaryMean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26-0.11 ± 0.03-0.20 ± 0.03-0.15 ± 0.03——
SecondaryMean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52-0.11 ± 0.04-0.19 ± 0.04-0.15 ± 0.04——
SecondaryMean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78

Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · mmol/L
Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78———0.03 ± 0.30.02 ± 0.3
SecondaryMean Change From Baseline in Triglycerides (TG) at Week 26

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Triglycerides (TG) at Week 26
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Triglycerides (TG) at Week 26-0.19 ± 0.10-0.43 ± 0.09-0.40 ± 0.09——
SecondaryMean Change From Baseline in Triglycerides (TG) at Week 52

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Triglycerides (TG) at Week 52
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Triglycerides (TG) at Week 52-0.10 ± 0.10-0.32 ± 0.10-0.23 ± 0.10——
SecondaryMean Change in Triglycerides (TG) From Week 52 to Week 78

Mean change in triglycerides (TG) from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · mmol/L
Mean Change in Triglycerides (TG) From Week 52 to Week 78
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Triglycerides (TG) From Week 52 to Week 78———-0.20 ± 0.8-0.26 ± 0.8
SecondaryMean Change From Baseline in Free Fatty Acids (FFA) at Week 26

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26-0.03 ± 0.02-0.07 ± 0.02-0.05 ± 0.02——
SecondaryMean Change From Baseline in Free Fatty Acids (FFA) at Week 52

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmol/L
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52-0.07 ± 0.02-0.10 ± 0.02-0.06 ± 0.02——
SecondaryMean Change in Free Fatty Acids (FFA) From Week 52 to Week 78

Mean change in free fatty acids (FFA) from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · mmol/L
Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78———0.02 ± 0.3-0.01 ± 0.3
SecondaryMean Change From Baseline in Apolipoprotein B at Week 26

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · g/L
Mean Change From Baseline in Apolipoprotein B at Week 26
g/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Apolipoprotein B at Week 26-0.06 ± 0.01-0.07 ± 0.01-0.05 ± 0.01——
SecondaryMean Change From Baseline in Apolipoprotein B at Week 52

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · g/L
Mean Change From Baseline in Apolipoprotein B at Week 52
g/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Apolipoprotein B at Week 52-0.03 ± 0.01-0.03 ± 0.01-0.03 ± 0.01——
SecondaryMean Change in Apolipoprotein B From Week 52 to Week 78

Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · mmol/L
Mean Change in Apolipoprotein B From Week 52 to Week 78
mmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Apolipoprotein B From Week 52 to Week 78———0.23 ± 0.40.17 ± 0.4
SecondaryMean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26

Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mg/L
Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
mg/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26-1.02 ± 0.31-0.99 ± 0.31-0.66 ± 0.31——
SecondaryMean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.

Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · U/L
Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
U/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.-833 ± 945.1-561 ± 941.1586 ± 952——
SecondaryMean Change From Baseline in Interleukin-6 (IL-6) at Week 26.

Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · pg/mL
Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
pg/mLLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.-1.70 ± 2.491.71 ± 2.470.91 ± 2.49——
SecondaryMean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · pmol/L
Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
pmol/LLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.5.19 ± 2.073.74 ± 2.063.71 ± 2.07——
SecondaryMean Change From Baseline in Adiponectin at Week 26.

Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mcg/mL
Mean Change From Baseline in Adiponectin at Week 26.
mcg/mLLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Adiponectin at Week 26.1.69 ± 0.191.51 ± 0.191.35 ± 0.19——
SecondaryMean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · pg/mL
Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
pg/mLLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.-0.55 ± 0.25-0.74 ± 0.25-0.53 ± 0.25——
SecondaryMean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.

Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · percentage point
Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
percentage pointLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.-1.73 ± 2.77-4.34 ± 2.76-1.8 ± 2.82——
SecondaryMean Change From Baseline in Waist to Hip Ratio at Week 26.

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · cm/cm
Mean Change From Baseline in Waist to Hip Ratio at Week 26.
cm/cmLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Waist to Hip Ratio at Week 26.-0.01 ± 0.00-0.01 ± 0.00-0.00 ± 0.00——
SecondaryMean Change From Baseline in Waist to Hip Ratio at Week 52

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · cm/cm
Mean Change From Baseline in Waist to Hip Ratio at Week 52
cm/cmLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Waist to Hip Ratio at Week 52-0.00 ± 0.00-0.01 ± 0.00-0.00 ± 0.00——
SecondaryMean Change in Waist to Hip Ratio From Week 52 to Week 78

Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Time frame:
Week 52, Week 78
Reported as:
Mean · cm/cm
Mean Change in Waist to Hip Ratio From Week 52 to Week 78
cm/cmLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Waist to Hip Ratio From Week 52 to Week 78———-0.01 ± 0-0.00 ± 0
SecondaryMean Change From Baseline in Waist Circumference at Week 26.

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · cm
Mean Change From Baseline in Waist Circumference at Week 26.
cmLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Waist Circumference at Week 26.-2.69 ± 0.35-2.63 ± 0.36-1.12 ± 0.36——
SecondaryMean Change From Baseline in Waist Circumference at Week 52

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · participants
Mean Change From Baseline in Waist Circumference at Week 52
participantsLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Waist Circumference at Week 52-2.36 ± 0.38-3.02 ± 0.38-1.23 ± 0.38——
SecondaryMean Change in Waist Circumference From Week 52 to Week 78

Mean change in Waist Circumference from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · kg
Mean Change in Waist Circumference From Week 52 to Week 78
kgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Waist Circumference From Week 52 to Week 78———-1.33 ± 3.5-2.05 ± 4.1
SecondaryMean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mmHg
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
mmHgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26-0.55 ± 0.89-0.72 ± 0.89-0.94 ± 0.89——
SecondaryMean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmHg
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
mmHgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52-0.37 ± 0.93-2.55 ± 0.93-1.03 ± 0.93——
SecondaryMean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78

Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · mmHg
Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
mmHgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78———-2.12 ± 14.60.35 ± 12.4
SecondaryMean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · mmHg
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
mmHgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26-0.71 ± 0.600.07 ± 0.59-1.78 ± 0.60——
SecondaryMean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmHg
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
mmHgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52-0.53 ± 0.57-0.87 ± 0.57-1.47 ± 0.57——
SecondaryMean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78

Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · mmHg
Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
mmHgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78———-0.60 ± 10.00.03 ± 8.9
SecondaryMean Change From Baseline in Pulse at Week 26

Calculated as an estimate of the mean change from baseline in pulse at Week 26.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · beats/minute
Mean Change From Baseline in Pulse at Week 26
beats/minuteLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Pulse at Week 262.32 ± 0.593.94 ± 0.58-0.64 ± 0.59——
SecondaryMean Change From Baseline in Pulse at Week 52

Calculated as an estimate of the mean change from baseline in pulse at Week 52.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · mmHg
Mean Change From Baseline in Pulse at Week 52
mmHgLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Pulse at Week 521.72 ± 0.603.09 ± 0.600.09 ± 0.60——
SecondaryMean Change in Pulse From Week 52 to Week 78

Mean change in pulse from Week 52 to Week 78.

Time frame:
Week 52, Week 78
Reported as:
Mean · beats/minute
Mean Change in Pulse From Week 52 to Week 78
beats/minuteLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Pulse From Week 52 to Week 78———0.90 ± 8.42.19 ± 7.7
SecondaryMean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

Time frame:
Week 0, Week 26
Reported as:
Least squares mean · scores on a scale
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
scores on a scaleLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 263.51 ± 0.494.35 ± 0.482.96 ± 0.48——
SecondaryMean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

Time frame:
Week 0, Week 52
Reported as:
Least squares mean · scores on a scale
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
scores on a scaleLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 523.32 ± 0.494.31 ± 0.482.96 ± 0.48——
SecondaryMean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

Time frame:
Week 52, Week 78
Reported as:
Mean · scores on a scale
Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78
scores on a scaleLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78———1.48 ± 4.40.98 ± 6.1
SecondaryHypoglyceamic Episodes, Weeks 0-26

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Time frame:
Weeks 0-26
Reported as:
Number · episodes
Hypoglyceamic Episodes, Weeks 0-26
episodesLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Major100——
Minor173711——
Symptoms only121510——
Unclassified010——
SecondaryHypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Time frame:
Weeks 0-26
Reported as:
Number · episodes
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
episodesLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Major100——
Minor171611——
Symptoms only121510——
Unclassified010——
SecondaryHypoglyceamic Episodes, Weeks 0-52

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Time frame:
Weeks 0-52
Reported as:
Number · episodes
Hypoglyceamic Episodes, Weeks 0-52
episodesLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Major100——
Minor245125——
Symptoms only142912——
Unclassified010——
SecondaryHypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Time frame:
Weeks 0-52
Reported as:
Number · episodes
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
episodesLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Major100——
Minor242825——
Symptoms only142912——
Unclassified010——
SecondaryHypoglyceamic Episodes, Weeks 0-78

Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Time frame:
Weeks 0-78
Reported as:
Number · episodes
Hypoglyceamic Episodes, Weeks 0-78
episodesLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Major200——
Minor365634——
Symptoms only184013——
Unclassified010——
SecondaryHypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78

Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Time frame:
Weeks 0-78
Reported as:
Number · episodes
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
episodesLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Major200——
Minor363334——
Symptoms only184013——
Unclassified010——
SecondaryHypoglycaamic Episodes, Weeks 52-78

Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Time frame:
Week 52-78
Reported as:
Number · episodes
Hypoglycaamic Episodes, Weeks 52-78
episodesLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg
Major10—00
Minor125—36
Symptoms only311—10
Unclassified00—00

Adverse events

Collected over The adverse events were collected in a timeframe of 78 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg—12/221 (5.4%)120/221 (54.3%)
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg—19/218 (8.7%)134/218 (61.5%)
Sita -> Sita—17/219 (7.8%)106/219 (48.4%)
Most frequent serious events
Showing 10 of 63
Most frequent serious events
EventLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> Sita
Cardiac failureCardiac disorders0/2212/2180/219
OsteoarthritisMusculoskeletal and connective tissue disorders2/2210/2180/219
Diabetic retinopathyEye disorders0/2211/2180/219
PapilloedemaEye disorders0/2211/2180/219
Mycetoma mycoticInfections and infestations0/2211/2180/219
Subdural haematomaInjury, poisoning and procedural complications0/2211/2180/219
Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2211/2180/219
EpistaxisRespiratory, thoracic and mediastinal disorders0/2211/2180/219
Abcess LimbInfections and infestations0/2211/2180/219
CellulitisInfections and infestations0/2211/2180/219
Most frequent other events
Showing 10 of 15
Most frequent other events
EventLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> Sita
NauseaGastrointestinal disorders48/22161/21836/219
NasopharyngitisInfections and infestations33/22136/21832/219
HeadacheNervous system disorders23/22131/21833/219
DiarrhoeaGastrointestinal disorders21/22129/21824/219
VomitingGastrointestinal disorders18/22124/21815/219
DyspepsiaGastrointestinal disorders8/22117/21811/219
Upper respiratory tract infectionInfections and infestations16/22111/21814/219
ConstipationGastrointestinal disorders10/22114/21810/219
Back painMusculoskeletal and connective tissue disorders13/22114/21813/219
DizzinessNervous system disorders10/22114/2188/219

Baseline characteristics

Age, Continuous
Age, Continuous(years)Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mgTotal
Mean55.9 ± 9.655.0 ± 9.155.0 ± 9.0——55.3 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mgTotal
Female10910599——313
Male116116120——352
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mgTotal
Hispanic or Latino393435——108
Not Hispanic or Latino186187184——557
Unknown or Not Reported000——0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mgTotal
American Indian or Alaska Native300——3
Asian641——11
Native Hawaiian or Other Pacific Islander101——2
Black or African American221610——48
White184193199——576
More than one race000——0
Unknown or Not Reported988——25
Body Mass Index (BMI) at Screening
Body Mass Index (BMI) at Screening(kg/m^2)Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mgTotal
Mean32.6 ± 5.233.1 ± 5.132.6 ± 5.4——32.8 ± 5.2
Duration of Diabetes
Duration of Diabetes(years)Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mgTotal
Mean6.0 ± 4.56.4 ± 5.46.3 ± 5.4——6.2 ± 5.1
Fasting Plasma Glucose (FPG) at Randomisation
Fasting Plasma Glucose (FPG) at Randomisation(mmol/L)Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mgTotal
Mean10.1 ± 2.49.9 ± 2.410.0 ± 2.0——10.0 ± 2.3
Glycosylated Haemoglobin A1c (HbA1c) at Randomisation
Glycosylated Haemoglobin A1c (HbA1c) at Randomisation(Percentage point of total HbA1c)Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mgTotal
Mean8.4 ± 0.88.4 ± 0.78.5 ± 0.7——8.4 ± 0.8
08

Study locations

166 sites
  • Novo Nordisk Investigational Site
    Birmingham, Alabama 35242, United States
  • Novo Nordisk Investigational Site
    Escondido, California 92025, United States
  • Novo Nordisk Investigational Site
    Fresno, California 93720, United States
  • Novo Nordisk Investigational Site
    Huntington Beach, California 92646, United States
  • Novo Nordisk Investigational Site
    Long Beach, California 90822, United States
  • Novo Nordisk Investigational Site
    Northridge, California 91325, United States
  • Novo Nordisk Investigational Site
    Orange, California 92869, United States
  • Novo Nordisk Investigational Site
    Poway, California 92064, United States
  • Novo Nordisk Investigational Site
    Walnut Creek, California 94598, United States
  • Novo Nordisk Investigational Site
    Denver, Colorado 80209, United States
  • Novo Nordisk Investigational Site
    Crystal River, Florida 34429, United States
  • Novo Nordisk Investigational Site
    Jacksonville, Florida 32205, United States
  • Novo Nordisk Investigational Site
    Jacksonville, Florida 32216, United States
  • Novo Nordisk Investigational Site
    Miami, Florida 33169, United States
  • Novo Nordisk Investigational Site
    Ocala, Florida 34471, United States
  • Novo Nordisk Investigational Site
    Panama City, Florida 32401, United States
  • Novo Nordisk Investigational Site
    St. Cloud, Florida 34769, United States
  • Novo Nordisk Investigational Site
    Athens, Georgia 30606, United States
  • Novo Nordisk Investigational Site
    Atlanta, Georgia 30342, United States
  • Novo Nordisk Investigational Site
    Dunwoody, Georgia 30338, United States
  • Novo Nordisk Investigational Site
    Lithia Springs, Georgia 30122, United States
  • Novo Nordisk Investigational Site
    Honolulu, Hawaii 96814, United States
  • Novo Nordisk Investigational Site
    Boise, Idaho 83702, United States
  • Novo Nordisk Investigational Site
    Chicago, Illinois 60616, United States
  • Novo Nordisk Investigational Site
    Shawnee Mission, Kansas 66204, United States
  • Novo Nordisk Investigational Site
    Metairie, Louisiana 70002, United States
  • Novo Nordisk Investigational Site
    Hyattsville, Maryland 20782, United States
  • Novo Nordisk Investigational Site
    Minneapolis, Minnesota 55416, United States
  • Novo Nordisk Investigational Site
    Cleveland, Mississippi 38732, United States
  • Novo Nordisk Investigational Site
    St. Peters, Missouri 63376, United States
  • Novo Nordisk Investigational Site
    Las Vegas, Nevada 89109, United States
  • Novo Nordisk Investigational Site
    Berlin, New Jersey 08009, United States
  • Novo Nordisk Investigational Site
    Northport, New York 11768, United States
  • Novo Nordisk Investigational Site
    Rosedale, New York 11422, United States
  • Novo Nordisk Investigational Site
    Pinehurst, North Carolina 28374, United States
  • Novo Nordisk Investigational Site
    Tabor City, North Carolina 28463, United States
  • Novo Nordisk Investigational Site
    Cincinnati, Ohio 45245, United States
  • Novo Nordisk Investigational Site
    Columbus, Ohio 43201, United States
  • Novo Nordisk Investigational Site
    Cuyahoga Falls, Ohio 44223, United States
  • Novo Nordisk Investigational Site
    Dayton, Ohio 45406, United States
  • Novo Nordisk Investigational Site
    Dayton, Ohio 45439, United States
  • Novo Nordisk Investigational Site
    Mentor, Ohio 44060, United States
  • Novo Nordisk Investigational Site
    Eugene, Oregon 97404, United States
  • Novo Nordisk Investigational Site
    Altoona, Pennsylvania 16602, United States
  • Novo Nordisk Investigational Site
    Norristown, Pennsylvania 19401, United States
  • Novo Nordisk Investigational Site
    Kingsport, Tennessee 37660, United States
  • Novo Nordisk Investigational Site
    Arlington, Texas 76014, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75230, United States
  • Novo Nordisk Investigational Site
    Houston, Texas 77024, United States
  • Novo Nordisk Investigational Site
    Houston, Texas 77030, United States
  • Novo Nordisk Investigational Site
    Hurst, Texas 76054, United States
  • Novo Nordisk Investigational Site
    New Braunfels, Texas 78130, United States
  • Novo Nordisk Investigational Site
    San Antonio, Texas 78229, United States
  • Novo Nordisk Investigational Site
    Sugar Land, Texas 77479, United States
  • Novo Nordisk Investigational Site
    Ogden, Utah 84403, United States
  • Novo Nordisk Investigational Site
    St. George, Utah 84790, United States
  • Novo Nordisk Investigational Site
    South Burlington, Vermont 05403, United States
  • Novo Nordisk Investigational Site
    Newport News, Virginia 23606, United States
  • Novo Nordisk Investigational Site
    Richmond, Virginia 23294, United States
  • Novo Nordisk Investigational Site
    Milwaukee, Wisconsin 53209, United States
  • Novo Nordisk Investigational Site
    Edmonton, Alberta T5A 4L8, Canada
  • Novo Nordisk Investigational Site
    Vancouver, British Columbia V5Z 1M9, Canada
  • Novo Nordisk Investigational Site
    London, Ontario N6G 2M1, Canada
  • Novo Nordisk Investigational Site
    Newmarket, Ontario L4Y 8E3, Canada
  • Novo Nordisk Investigational Site
    Ottawa, Ontario K1N 6N5, Canada
  • Novo Nordisk Investigational Site
    Toronto, Ontario M3J 1N2, Canada
  • Novo Nordisk Investigational Site
    Toronto, Ontario M5C 2T2, Canada
  • Novo Nordisk Investigational Site
    Toronto, Ontario M5T 3L9, Canada
  • Novo Nordisk Investigational Site
    Montreal, Quebec H2W 1T8, Canada
  • Novo Nordisk Investigational Site
    Montreal, Quebec H3J 2V5, Canada
  • Novo Nordisk Investigational Site
    Hamilton, L8M 1K7, Canada
  • Novo Nordisk Investigational Site
    Karlovac, 47000, Croatia
  • Novo Nordisk Investigational Site
    Sisak, 44000, Croatia
  • Novo Nordisk Investigational Site
    Slavonski Brod, 35 000, Croatia
  • Novo Nordisk Investigational Site
    Belgrade, 11000, Former Serbia and Montenegro
  • Novo Nordisk Investigational Site
    Nis, 18000, Former Serbia and Montenegro
  • Novo Nordisk Investigational Site
    LA ROCHE-sur-YON cedex 9, 85295, France
  • Novo Nordisk Investigational Site
    LA ROCHELLE cedex, 17019, France
  • Novo Nordisk Investigational Site
    Limoges, 87042, France
  • Novo Nordisk Investigational Site
    Narbonne, 11108, France
  • Novo Nordisk Investigational Site
    Rennes, 35056, France
  • Novo Nordisk Investigational Site
    Saint Mandé, 94160, France
  • Novo Nordisk Investigational Site
    Strasbourg, 67000, France
  • Novo Nordisk Investigational Site
    Venissieux, 69200, France
  • Novo Nordisk Investigational Site
    Bad Lauterberg, 37431, Germany
  • Novo Nordisk Investigational Site
    Bochum, 44791, Germany
  • Novo Nordisk Investigational Site
    Dormagen, 41539, Germany
  • Novo Nordisk Investigational Site
    Frankfurt, 60388, Germany
  • Novo Nordisk Investigational Site
    Herrenberg, 71083, Germany
  • Novo Nordisk Investigational Site
    Kassel, 34117, Germany
  • Novo Nordisk Investigational Site
    Marburg, 35039, Germany
  • Novo Nordisk Investigational Site
    Riesa, 01587, Germany
  • Novo Nordisk Investigational Site
    Schönebeck, 39218, Germany
  • Novo Nordisk Investigational Site
    Ulm, 89073, Germany
  • Novo Nordisk Investigational Site
    Völklingen, 66333, Germany
  • Novo Nordisk Investigational Site
    Wangen, 88239, Germany
  • Novo Nordisk Investigational Site
    Dublin 9, Ireland
  • Novo Nordisk Investigational Site
    Dublin, DUBLIN 15, Ireland
  • Novo Nordisk Investigational Site
    Dublin, DUBLIN 4, Ireland
  • Novo Nordisk Investigational Site
    Dublin, DUBLIN 7, Ireland

Showing the first 100 of 166 sites across 15 countries.

09

References and documents

Publications

  • Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, Sondergaard RE, Davies M; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010 Apr 24;375(9724):1447-56. doi: 10.1016/S0140-6736(10)60307-8. Erratum In: Lancet. 2010 Jul 24;376(9737):234. PubMed 20417856 ↗
  • Davies M, Pratley R, Hammer M, Thomsen AB, Cuddihy R. Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. Diabet Med. 2011 Mar;28(3):333-7. doi: 10.1111/j.1464-5491.2010.03074.x. PubMed 21309842 ↗
  • Pratley R, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Garber A, Thomsen AB, Hartvig H, Davies M; 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011 Apr;65(4):397-407. doi: 10.1111/j.1742-1241.2011.02656.x. Epub 2011 Mar 1. PubMed 21355967 ↗
  • Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906. PubMed 22193143 ↗
  • Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30. PubMed 21883806 ↗
  • Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x. PubMed 21883438 ↗
  • Pratley RE, Nauck MA, Bailey T, Montanya E, Filetti S, Garber AJ, Thomsen AB, Furber S, Davies M; 1860-LIRA-DPP-4 Study Group. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial. Diabetes Care. 2012 Oct;35(10):1986-93. doi: 10.2337/dc11-2113. Epub 2012 Jul 30. PubMed 22851600 ↗
  • Lee WC, Samyshkin Y, Langer J, Palmer JL. Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis. J Med Econ. 2012;15 Suppl 2:28-37. doi: 10.3111/13696998.2012.716111. Epub 2012 Aug 13. PubMed 22834986 ↗
  • Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9. PubMed 22862847 ↗
  • Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23. PubMed 23010561 ↗
  • King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR. PubMed 23186975 ↗
  • Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622. doi: 10.2337/dc15-er08. PubMed 25504028 ↗
  • Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28. PubMed 26936426 ↗
  • Langer J, Hunt B, Valentine WJ. Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States. J Manag Care Pharm. 2013 Apr;19(3):237-46. doi: 10.18553/jmcp.2013.19.3.237. PubMed 23537458 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00700817
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jun 19, 2008
Start date
Jun 2008
Primary completion
Jun 2009
Completion
Jun 2010
Results posted
Aug 4, 2010
Last update
Mar 8, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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