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CompletedNCT00620282Updated Mar 8, 2017Results posted

The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

A Phase 3 interventional study of liraglutide and placebo in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to participants aged 40 Years to 70 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
49
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

This trial is conducted in the United States of America (USA). The purpose of the trial is to assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who are on diet and lifestyle changes or treated with metformin alone.

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 49 is below 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
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes
  • Diet and lifestyle changes or metformin monotherapy for at least three months
  • HbA1c (glycosylated haemoglobin) 6.5-9.0% (both inclusive)
  • Body Mass Index (BMI) less than or equal to 40 kg/m\^2

Exclusion criteria

Exclusion Criteria:

  • Previous treatment with insulin (except for short term treatment with insulin in connection with intercurrent illness, at the discretion of the Investigator)
  • Previous treatment with glucagon-like peptide-1 (GLP-1) analogues/mimetics, including treatment in a clinical trial
  • Treatment with any oral hypoglycaemic agents other than metformin in a period of 3 months prior to screening
  • Current smoker or history of smoking within 6 months prior to screening
  • Evidence of overt cardiovascular disease (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease)
  • Abnormal, clinically significant exercise stress electrocardiogram (ECG) test, as judged by the Investigator
  • Known retinopathy or maculopathy requiring acute treatment, as judged by the Investigator
  • Known autonomic neuropathy, as judged by the Investigator
  • Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering or lipid-lowering medication within 4 weeks prior to screening
  • Systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equal to 90 mmHg
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Lira 1.8

    Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)

    Drug: liraglutide

  • Placebo comparator
    Placebo

    Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)

    Drug: placebo

  • Active comparator
    Glimepiride

    Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12

    Drug: glimepiride

Interventions

  • Drugliraglutide

    Stepwise dose increase, s.c. (under the skin) injection, once daily

  • Drugplacebo

    Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily

  • Drugglimepiride

    Tablets, 1 - 4 mg daily

06

What researchers measure

Primary outcomes

  1. Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)

    Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.

    Time frame: week 0, week 12

Secondary outcomes

  1. Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)

    Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.

    Time frame: week 0, week 12

  2. Change in HbA1c (Glycosylated Haemoglobin A1c)

    Percentage point change in HbA1c

    Time frame: week 0, week 12

  3. Change in Fasting Plasma Glucose (FPG)

    Change in FPG

    Time frame: week 0, week 12

  4. Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles

    The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.

    Time frame: week 0, week 12

  5. Change in Body Weight

    Time frame: week 0, week 12

  6. Fasting Lipid Profile - Change in Total Cholesterol (TC)

    Change in TC

    Time frame: week 0, week 12

  7. Fasting Lipid Profile - Change in LDL-C

    Change in LDL-C

    Time frame: week 0, week 12

  8. Fasting Lipid Profile - Change in HDL-C

    Change in HDL-C

    Time frame: week 0, week 12

  9. Fasting Lipid Profile - Change in Triglycerides (TG)

    Change in TG

    Time frame: week 0, week 12

  10. Biomarkers of Cardiovascular Risk - Change in TNF-alpha

    Change in TNF-alpha

    Time frame: week 0, week 12

  11. Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range

    Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).

    Time frame: week 0, week 12

  12. Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range

    Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).

    Time frame: week 0, week 12

  13. Number of Hypoglycaemic Episodes

    Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.

    Time frame: weeks 0-12

07

Results

Posted Jun 15, 2011

Participant flow

The trial was conducted at one site in the United States of America (USA).

Participant flow — Overall Study
MilestoneLira 1.8PlaceboGlimepiride
Started161617
Completed161416
Not completed021
Withdrew: Adverse event010
Withdrew: Arterial line unable to be placed001
Withdrew: Withdrawal by subject010

Outcome measures

PrimaryChange in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)

Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.

Time frame:
week 0, week 12
Reported as:
Least squares mean · mL/100 mL/min
Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)
mL/100 mL/minLira 1.8PlaceboGlimepiride
Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)4.244 ± 2.551-3.187 ± 2.7582.164 ± 2.568
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.0549 (2-sided significance level of 5%.) · Least squares mean: 7.43 · 95% CI -0.164 to 15.025
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.5681 (2-sided significance level of 5%.) · Least squares mean: 2.08 · 95% CI -5.215 to 9.375
  • Placebo vs Glimepiride · ANCOVA · p = 0.1668 (2-sided significance level of 5%.) · Least squares mean: 5.35 · 95% CI -2.323 to 13.024
SecondaryChange in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)

Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.

Time frame:
week 0, week 12
Reported as:
Least squares mean · mL/100 mL/min
Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)
mL/100 mL/minLira 1.8PlaceboGlimepiride
Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)3.455 ± 2.681-1.044 ± 2.8932.746 ± 2.67
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.2648 (2-sided significance level of 5%.) · Least squares mean: 4.499 · 95% CI -3.535 to 12.534
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.8518 (2-sided significance level of 5%.) · Least squares mean: 0.709 · 95% CI -6.904 to 8.322
  • Placebo vs Glimepiride · ANCOVA · p = 0.3435 (2-sided significance level of 5%.) · Least squares mean: 3.79 · 95% CI -4.194 to 11.774
SecondaryChange in HbA1c (Glycosylated Haemoglobin A1c)

Percentage point change in HbA1c

Time frame:
week 0, week 12
Reported as:
Least squares mean · percentage of total haemoglobin
Change in HbA1c (Glycosylated Haemoglobin A1c)
percentage of total haemoglobinLira 1.8PlaceboGlimepiride
Change in HbA1c (Glycosylated Haemoglobin A1c)-0.629 ± 0.109-0.094 ± 0.121-0.552 ± 0.112
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.0023 (2-sided significance level of 5%.) · Least squares mean: -0.536 · 95% CI -0.868 to -0.203
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.6207 (2-sided significance level of 5%.) · Least squares mean: -0.077 · 95% CI -0.391 to 0.236
  • Placebo vs Glimepiride · ANCOVA · p = 0.0098 (2-sided significance level of 5%.) · Least squares mean: -0.458 · 95% CI -0.8 to -0.116
SecondaryChange in Fasting Plasma Glucose (FPG)

Change in FPG

Time frame:
week 0, week 12
Reported as:
Least squares mean · mg/dL
Change in Fasting Plasma Glucose (FPG)
mg/dLLira 1.8PlaceboGlimepiride
Change in Fasting Plasma Glucose (FPG)-41.672 ± 3.643-6.067 ± 4.079-32.019 ± 3.708
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · Least squares mean: -35.605 · 95% CI -46.797 to -24.413
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.0677 (2-sided significance level of 5%.) · Least squares mean: -9.653 · 95% CI -20.041 to 0.736
  • Placebo vs Glimepiride · ANCOVA · Least squares mean: -25.952 · 95% CI -37.429 to -14.475
SecondaryChange in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles

The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.

Time frame:
week 0, week 12
Reported as:
Least squares mean · mg/dL
Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles
mg/dLLira 1.8PlaceboGlimepiride
Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles-32.175 ± 9.104-20.304 ± 10.619-35.99 ± 8.673
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.4121 (2-sided significance level of 5%.) · Least squares mean: -11.871 · 95% CI -40.943 to 17.201
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.7622 (2-sided significance level of 5%) · Least squares mean: 3.815 · 95% CI -21.618 to 29.247
  • Placebo vs Glimepiride · ANCOVA · p = 0.2651 (2-sided significance level of 5%.) · Least squares mean: -15.686 · 95% CI -43.838 to 12.466
SecondaryChange in Body Weight
Time frame:
week 0, week 12
Reported as:
Least squares mean · kg
Change in Body Weight
kgLira 1.8PlaceboGlimepiride
Change in Body Weight-1.821 ± 0.455-0.293 ± 0.4861.038 ± 0.441
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.0268 (2-sided significance level of 5%.) · Least squares mean: -1.528 · 95% CI -2.873 to -0.184
  • Lira 1.8 vs Glimepiride · ANCOVA · Least squares mean: -2.859 · 95% CI -4.139 to -1.579
  • Placebo vs Glimepiride · ANCOVA · p = 0.0486 (2-sided significance level of 5%.) · Least squares mean: 1.331 · 95% CI 0.0090 to 2.653
SecondaryFasting Lipid Profile - Change in Total Cholesterol (TC)

Change in TC

Time frame:
week 0, week 12
Reported as:
Least squares mean · mg/dL
Fasting Lipid Profile - Change in Total Cholesterol (TC)
mg/dLLira 1.8PlaceboGlimepiride
Fasting Lipid Profile - Change in Total Cholesterol (TC)2.006 ± 5.2744.243 ± 5.5970.094 ± 5.239
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.7736 (2-sided significance level of 5%.) · Least squares mean: -2.237 · 95% CI -17.829 to 13.354
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.7993 (2-sided significance level of 5%.) · Least squares mean: 1.912 · 95% CI -13.168 to 16.991
  • Placebo vs Glimepiride · ANCOVA · p = 0.5903 (2-sided significance level of 5%.) · Least squares mean: -4.149 · 95% CI -19.582 to 11.284
SecondaryFasting Lipid Profile - Change in LDL-C

Change in LDL-C

Time frame:
week 0, week 12
Reported as:
Least squares mean · mg/dL
Fasting Lipid Profile - Change in LDL-C
mg/dLLira 1.8PlaceboGlimepiride
Fasting Lipid Profile - Change in LDL-C1.243 ± 4.294-2.459 ± 4.551-1.529 ± 4.275
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.5583 (2-sided significance level of 5%.) · Least squares mean: 3.702 · 95% CI -8.96 to 16.365
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.6517 (2-sided significance level of 5%.) · Least squares mean: 2.773 · 95% CI -9.537 to 15.082
  • Placebo vs Glimepiride · ANCOVA · p = 0.8822 (2-sided significance level of 5%.) · Least squares mean: 0.929 · 95% CI -11.646 to 13.505
SecondaryFasting Lipid Profile - Change in HDL-C

Change in HDL-C

Time frame:
week 0, week 12
Reported as:
Least squares mean · mg/dL
Fasting Lipid Profile - Change in HDL-C
mg/dLLira 1.8PlaceboGlimepiride
Fasting Lipid Profile - Change in HDL-C0.393 ± 1.0530.562 ± 1.1331.116 ± 1.074
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.9131 (2-sided significance level of 5%.) · Least squares mean: -0.169 · 95% CI -3.273 to 2.935
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.6362 (2-sided significance level of 5%.) · Least squares mean: -0.723 · 95% CI -3.785 to 2.339
  • Placebo vs Glimepiride · ANCOVA · p = 0.7283 (2-sided significance level of 5%.) · Least squares mean: 0.554 · 95% CI -2.643 to 3.751
SecondaryFasting Lipid Profile - Change in Triglycerides (TG)

Change in TG

Time frame:
week 0, week 12
Reported as:
Least squares mean · mg/dL
Fasting Lipid Profile - Change in Triglycerides (TG)
mg/dLLira 1.8PlaceboGlimepiride
Fasting Lipid Profile - Change in Triglycerides (TG)-8.163 ± 13.47128.546 ± 14.282-4.377 ± 13.399
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.0694 (2-sided significance level of 5%.) · Least squares mean: -36.709 · 95% CI -76.467 to 3.048
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.844 (2-sided significance level of 5%.) · Least squares mean: -3.786 · 95% CI -42.373 to 34.801
  • Placebo vs Glimepiride · ANCOVA · p = 0.0994 (2-sided significance level of 5%.) · Least squares mean: -32.923 · 95% CI -72.353 to 6.507
SecondaryBiomarkers of Cardiovascular Risk - Change in TNF-alpha

Change in TNF-alpha

Time frame:
week 0, week 12
Reported as:
Least squares mean · pg/mL
Biomarkers of Cardiovascular Risk - Change in TNF-alpha
pg/mLLira 1.8PlaceboGlimepiride
Biomarkers of Cardiovascular Risk - Change in TNF-alpha-0.024 ± 0.2320.397 ± 0.25-0.0050 ± 0.231
Statistical analysis
  • Lira 1.8 vs Placebo · ANCOVA · p = 0.2282 (2-sided significance level of 5%.) · Least squares mean: -0.42 · 95% CI -1.118 to 0.278
  • Lira 1.8 vs Glimepiride · ANCOVA · p = 0.9569 (2-sided significance level of 5%.) · Least squares mean: -0.018 · 95% CI -0.697 to 0.661
  • Placebo vs Glimepiride · ANCOVA · p = 0.2465 (2-sided significance level of 5%.) · Least squares mean: -0.402 · 95% CI -1.097 to 0.293
SecondaryHaematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range

Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).

Time frame:
week 0, week 12
Reported as:
Number · participants
Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range
participantsLira 1.8PlaceboGlimepiride
Week 0101
Week 12120
SecondaryHaematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range

Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).

Time frame:
week 0, week 12
Reported as:
Number · participants
Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range
participantsLira 1.8PlaceboGlimepiride
Week 0135
Week 12122
SecondaryNumber of Hypoglycaemic Episodes

Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.

Time frame:
weeks 0-12
Reported as:
Number · episodes
Number of Hypoglycaemic Episodes
episodesLira 1.8PlaceboGlimepiride
Major000
Minor1010
Symptoms Only304

Adverse events

Collected over The adverse events were collected from week 0 to week 12.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lira 1.8—0/16 (0%)11/16 (68.8%)
Placebo—1/16 (6.3%)9/16 (56.3%)
Glimepiride—0/17 (0%)5/17 (29.4%)
Most frequent serious events
Most frequent serious events
EventLira 1.8PlaceboGlimepiride
Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/161/160/17
Most frequent other events
Showing 10 of 39
Most frequent other events
EventLira 1.8PlaceboGlimepiride
DyspepsiaGastrointestinal disorders2/160/160/17
NauseaGastrointestinal disorders2/160/160/17
VomitingGastrointestinal disorders2/160/160/17
Abdominal pain upperGastrointestinal disorders1/160/160/17
DiarrhoeaGastrointestinal disorders1/160/160/17
Parotid Duct ObstructionGastrointestinal disorders1/160/160/17
Chest PainGeneral disorders0/161/160/17
FatigueGeneral disorders0/161/160/17
Oedema peripheralGeneral disorders1/160/160/17
BronchitisInfections and infestations0/161/160/17

Baseline characteristics

Age, Continuous
Age, Continuous(years)Lira 1.8PlaceboGlimepirideTotal
Mean57.7 ± 9.060.3 ± 7.357.7 ± 5.358.5 ± 7.3
Sex: Female, Male
Sex: Female, Male(Participants)Lira 1.8PlaceboGlimepirideTotal
Female66618
Male10101131
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lira 1.8PlaceboGlimepirideTotal
Hispanic or Latino0000
Not Hispanic or Latino16161749
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Lira 1.8PlaceboGlimepirideTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White16161749
More than one race0000
Unknown or Not Reported0000
Duration of Diabetes
Duration of Diabetes(years)Lira 1.8PlaceboGlimepirideTotal
Mean5.3 ± 4.18.4 ± 4.66.8 ± 8.16.8 ± 6.0
Previous Anti-diabetic Treatment
Previous Anti-diabetic Treatment(participants)Lira 1.8PlaceboGlimepirideTotal
Diet/Exercise2125
Metformin14151544
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Lira 1.8PlaceboGlimepirideTotal
Mean32.7 ± 4.531.6 ± 4.231.1 ± 4.931.8 ± 4.5
Body Weight
Body Weight(kg)Lira 1.8PlaceboGlimepirideTotal
Mean95.09 ± 13.1290.63 ± 13.4791.99 ± 13.9792.56 ± 13.38

7 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Novo Nordisk Investigational Site
    Rochester, Minnesota 55905, United States
09

References and documents

Publications

  • 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 ↗
  • Nandy D, Johnson C, Basu R, Joyner M, Brett J, Svendsen CB, Basu A. The effect of liraglutide on endothelial function in patients with type 2 diabetes. Diab Vasc Dis Res. 2014 Nov;11(6):419-30. doi: 10.1177/1479164114547358. Epub 2014 Sep 11. PubMed 25212693 ↗
  • 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 ↗
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
NCT00620282
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 21, 2008
Start date
Feb 2008
Primary completion
May 2010
Completion
May 2010
Results posted
Jun 15, 2011
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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