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
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:
Week 27-52 after randomisation
Week 53-78 after randomisation
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 →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.
Exclusion Criteria:
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
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
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
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
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
1.2 mg once daily, subcutaneous (under the skin) injection
Tablets, 100 mg daily
Tablets, minimum 1500 mg daily
1.8 mg once daily, subcutaneous (under the skin) injection
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Started | 225 | 221 | 219 | 0 | 0 |
| Exposed | 221 | 218 | 219 | 0 | 0 |
| Completed | 169 | 191 | 194 | 0 | 0 |
| Not completed | 56 | 30 | 25 | 0 | 0 |
| Withdrew: Adverse event | 14 | 15 | 4 | 0 | 0 |
| Withdrew: Lack of efficacy | 4 | 0 | 4 | 0 | 0 |
| Withdrew: Protocol violation | 14 | 4 | 4 | 0 | 0 |
| Withdrew: Withdrawal criteria | 10 | 7 | 5 | 0 | 0 |
| Withdrew: Unclassified | 14 | 4 | 8 | 0 | 0 |
| Milestone | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Started | 155 | 176 | 166 | 0 | 0 |
| Completed | 135 | 150 | 151 | 0 | 0 |
| Not completed | 20 | 26 | 15 | 0 | 0 |
| Withdrew: Adverse event | 5 | 10 | 3 | 0 | 0 |
| Withdrew: Protocol violation | 3 | 2 | 2 | 0 | 0 |
| Withdrew: Lack of efficacy | 2 | 3 | 7 | 0 | 0 |
| Withdrew: Withdrawal criteria | 6 | 8 | 2 | 0 | 0 |
| Withdrew: Unclassified | 4 | 3 | 1 | 0 | 0 |
| Milestone | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Started | 134 | 150 | 0 | 67 | 68 |
| Completed | 124 | 135 | 0 | 59 | 63 |
| Not completed | 10 | 15 | 0 | 8 | 5 |
| Withdrew: Adverse event | 0 | 3 | 0 | 6 | 0 |
| Withdrew: Protocol violation | 1 | 2 | 0 | 1 | 1 |
| Withdrew: Lack of efficacy | 3 | 3 | 0 | 0 | 0 |
| Withdrew: Withdrawal criteria | 4 | 3 | 0 | 1 | 3 |
| Withdrew: Unclassified | 2 | 4 | 0 | 0 | 1 |
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
| Percentage point of total HbA1c | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
| Percentage point of total HbA1c | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
| Percentage point of total HbA1c | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — | — |
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
| Percentage point of total HbA1c | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 |
Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26
| percentage of subjects | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 | 43 | 55 | 22 | — | — |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 52
| percentage of subjects | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 | 50 | 63 | 27 | — | — |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the FAS.
| percentage of subjects | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 | 35 | 51 | — | — | — |
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.
| percentage of subjects | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 | — | — | — | 49 | 50 |
Calculated as the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 26
| percentage of subjects | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 | 23 | 36 | 12 | — | — |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 52
| percentage of subjects | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 | 24 | 40 | 17 | — | — |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the FAS.
| percentage of subjects | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 | 12 | 27 | — | — | — |
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.
| percentage of subjects | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 | — | — | — | 29 | 25 |
Calculated as an estimate of the mean change from baseline in body weight at Week 26.
| kg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the mean change from baseline in body weight at Week 52.
| kg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Mean change in body weight from Week 52 to Week 78.
| kg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Body Weight From Week 52 to Week 78 | — | — | — | -1.64 ± 3 | -2.48 ± 3.6 |
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — | — |
Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 |
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).
| percentage point | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Beta-cell Function at Week 26 | 27.23 ± 3.82 | 28.70 ± 3.75 | 4.18 ± 3.79 | — | — |
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).
| percentage point | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Beta-cell Function at Week 52 | 22.58 ± 3.31 | 25.76 ± 3.25 | 3.98 ± 3.30 | — | — |
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).
| percentage point | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Beta-cell Function From Week 52 to Week 78 | — | — | — | 13.31 ± 29.4 | 23.09 ± 43.7 |
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Total Cholesterol at Week 52 | -0.01 ± 0.06 | -0.09 ± 0.06 | 0.03 ± 0.06 | — | — |
Mean change in total cholesterol from Week 52 to Week 78
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Total Cholesterol From Week 52 to Week 78 | — | — | — | -0.16 ± 0.8 | -0.24 ± 0.7 |
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 | 0.08 ± 0.05 | 0.05 ± 0.05 | 0.13 ± 0.05 | — | — |
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 | 0.09 ± 0.05 | 0.09 ± 0.05 | 0.17 ± 0.05 | — | — |
Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 |
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 | 0.00 ± 0.01 | 0.00 ± 0.01 | 0.00 ± 0.01 | — | — |
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 | 0.01 ± 0.01 | 0.02 ± 0.01 | 0.01 ± 0.01 | — | — |
Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 |
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78 | — | — | — | 0.03 ± 0.3 | 0.02 ± 0.3 |
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Mean change in triglycerides (TG) from Week 52 to Week 78.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Triglycerides (TG) From Week 52 to Week 78 | — | — | — | -0.20 ± 0.8 | -0.26 ± 0.8 |
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Mean change in free fatty acids (FFA) from Week 52 to Week 78.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 |
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.
| g/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.
| g/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.
| mmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Apolipoprotein B From Week 52 to Week 78 | — | — | — | 0.23 ± 0.4 | 0.17 ± 0.4 |
Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.
| mg/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.
| U/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. | -833 ± 945.1 | -561 ± 941.1 | 586 ± 952 | — | — |
Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.
| pg/mL | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. | -1.70 ± 2.49 | 1.71 ± 2.47 | 0.91 ± 2.49 | — | — |
Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
| pmol/L | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. | 5.19 ± 2.07 | 3.74 ± 2.06 | 3.71 ± 2.07 | — | — |
Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.
| mcg/mL | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Adiponectin at Week 26. | 1.69 ± 0.19 | 1.51 ± 0.19 | 1.35 ± 0.19 | — | — |
Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
| pg/mL | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
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.
| percentage point | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
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.
| cm/cm | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
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.
| cm/cm | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
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.
| cm/cm | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Waist to Hip Ratio From Week 52 to Week 78 | — | — | — | -0.01 ± 0 | -0.00 ± 0 |
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26
| cm | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.
| participants | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Mean change in Waist Circumference from Week 52 to Week 78.
| kg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Waist Circumference From Week 52 to Week 78 | — | — | — | -1.33 ± 3.5 | -2.05 ± 4.1 |
Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26
| mmHg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.
| mmHg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.
| mmHg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78 | — | — | — | -2.12 ± 14.6 | 0.35 ± 12.4 |
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.
| mmHg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 | -0.71 ± 0.60 | 0.07 ± 0.59 | -1.78 ± 0.60 | — | — |
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.
| mmHg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> 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 | — | — |
Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.
| mmHg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78 | — | — | — | -0.60 ± 10.0 | 0.03 ± 8.9 |
Calculated as an estimate of the mean change from baseline in pulse at Week 26.
| beats/minute | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Pulse at Week 26 | 2.32 ± 0.59 | 3.94 ± 0.58 | -0.64 ± 0.59 | — | — |
Calculated as an estimate of the mean change from baseline in pulse at Week 52.
| mmHg | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Pulse at Week 52 | 1.72 ± 0.60 | 3.09 ± 0.60 | 0.09 ± 0.60 | — | — |
Mean change in pulse from Week 52 to Week 78.
| beats/minute | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Pulse From Week 52 to Week 78 | — | — | — | 0.90 ± 8.4 | 2.19 ± 7.7 |
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.
| scores on a scale | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 | 3.51 ± 0.49 | 4.35 ± 0.48 | 2.96 ± 0.48 | — | — |
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.
| scores on a scale | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 | 3.32 ± 0.49 | 4.31 ± 0.48 | 2.96 ± 0.48 | — | — |
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.
| scores on a scale | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78 | — | — | — | 1.48 ± 4.4 | 0.98 ± 6.1 |
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.
| episodes | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Major | 1 | 0 | 0 | — | — |
| Minor | 17 | 37 | 11 | — | — |
| Symptoms only | 12 | 15 | 10 | — | — |
| Unclassified | 0 | 1 | 0 | — | — |
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.
| episodes | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Major | 1 | 0 | 0 | — | — |
| Minor | 17 | 16 | 11 | — | — |
| Symptoms only | 12 | 15 | 10 | — | — |
| Unclassified | 0 | 1 | 0 | — | — |
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.
| episodes | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Major | 1 | 0 | 0 | — | — |
| Minor | 24 | 51 | 25 | — | — |
| Symptoms only | 14 | 29 | 12 | — | — |
| Unclassified | 0 | 1 | 0 | — | — |
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.
| episodes | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Major | 1 | 0 | 0 | — | — |
| Minor | 24 | 28 | 25 | — | — |
| Symptoms only | 14 | 29 | 12 | — | — |
| Unclassified | 0 | 1 | 0 | — | — |
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.
| episodes | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Major | 2 | 0 | 0 | — | — |
| Minor | 36 | 56 | 34 | — | — |
| Symptoms only | 18 | 40 | 13 | — | — |
| Unclassified | 0 | 1 | 0 | — | — |
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.
| episodes | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Major | 2 | 0 | 0 | — | — |
| Minor | 36 | 33 | 34 | — | — |
| Symptoms only | 18 | 40 | 13 | — | — |
| Unclassified | 0 | 1 | 0 | — | — |
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.
| episodes | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg |
|---|---|---|---|---|---|
| Major | 1 | 0 | — | 0 | 0 |
| Minor | 12 | 5 | — | 3 | 6 |
| Symptoms only | 3 | 11 | — | 1 | 0 |
| Unclassified | 0 | 0 | — | 0 | 0 |
Collected over The adverse events were collected in a timeframe of 78 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 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%) |
| Event | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita |
|---|---|---|---|
| Cardiac failureCardiac disorders | 0/221 | 2/218 | 0/219 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/221 | 0/218 | 0/219 |
| Diabetic retinopathyEye disorders | 0/221 | 1/218 | 0/219 |
| PapilloedemaEye disorders | 0/221 | 1/218 | 0/219 |
| Mycetoma mycoticInfections and infestations | 0/221 | 1/218 | 0/219 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/221 | 1/218 | 0/219 |
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/221 | 1/218 | 0/219 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/221 | 1/218 | 0/219 |
| Abcess LimbInfections and infestations | 0/221 | 1/218 | 0/219 |
| CellulitisInfections and infestations | 0/221 | 1/218 | 0/219 |
| Event | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita |
|---|---|---|---|
| NauseaGastrointestinal disorders | 48/221 | 61/218 | 36/219 |
| NasopharyngitisInfections and infestations | 33/221 | 36/218 | 32/219 |
| HeadacheNervous system disorders | 23/221 | 31/218 | 33/219 |
| DiarrhoeaGastrointestinal disorders | 21/221 | 29/218 | 24/219 |
| VomitingGastrointestinal disorders | 18/221 | 24/218 | 15/219 |
| DyspepsiaGastrointestinal disorders | 8/221 | 17/218 | 11/219 |
| Upper respiratory tract infectionInfections and infestations | 16/221 | 11/218 | 14/219 |
| ConstipationGastrointestinal disorders | 10/221 | 14/218 | 10/219 |
| Back painMusculoskeletal and connective tissue disorders | 13/221 | 14/218 | 13/219 |
| DizzinessNervous system disorders | 10/221 | 14/218 | 8/219 |
| Age, Continuous(years) | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 55.9 ± 9.6 | 55.0 ± 9.1 | 55.0 ± 9.0 | — | — | 55.3 ± 9.2 |
| Sex: Female, Male(Participants) | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg | Total |
|---|---|---|---|---|---|---|
| Female | 109 | 105 | 99 | — | — | 313 |
| Male | 116 | 116 | 120 | — | — | 352 |
| Ethnicity (NIH/OMB)(Participants) | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 39 | 34 | 35 | — | — | 108 |
| Not Hispanic or Latino | 186 | 187 | 184 | — | — | 557 |
| Unknown or Not Reported | 0 | 0 | 0 | — | — | 0 |
| Race (NIH/OMB)(Participants) | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 0 | 0 | — | — | 3 |
| Asian | 6 | 4 | 1 | — | — | 11 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 | — | — | 2 |
| Black or African American | 22 | 16 | 10 | — | — | 48 |
| White | 184 | 193 | 199 | — | — | 576 |
| More than one race | 0 | 0 | 0 | — | — | 0 |
| Unknown or Not Reported | 9 | 8 | 8 | — | — | 25 |
| Body Mass Index (BMI) at Screening(kg/m^2) | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 32.6 ± 5.2 | 33.1 ± 5.1 | 32.6 ± 5.4 | — | — | 32.8 ± 5.2 |
| Duration of Diabetes(years) | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 6.0 ± 4.5 | 6.4 ± 5.4 | 6.3 ± 5.4 | — | — | 6.2 ± 5.1 |
| Fasting Plasma Glucose (FPG) at Randomisation(mmol/L) | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 10.1 ± 2.4 | 9.9 ± 2.4 | 10.0 ± 2.0 | — | — | 10.0 ± 2.3 |
| Glycosylated Haemoglobin A1c (HbA1c) at Randomisation(Percentage point of total HbA1c) | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Sita -> Sita -> Lira 1.2 mg | Sita -> Sita -> Lira 1.8 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 8.4 ± 0.8 | 8.4 ± 0.7 | 8.5 ± 0.7 | — | — | 8.4 ± 0.8 |
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