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Completed

NCT Number: NCT00620282

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

liraglutide

Drug

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

Placebo

Drug

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

Glimepiride

Drug

Tablets, 1 - 4 mg daily

Primary outcomes

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

    Time frame: week 0, week 12

    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.

Secondary outcomes

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

    Time frame: week 0, week 12

    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.

  2. Change in HbA1c (Glycosylated Haemoglobin A1c)

    Time frame: week 0, week 12

    Percentage point change in HbA1c

  3. Change in Fasting Plasma Glucose (FPG)

    Time frame: week 0, week 12

    Change in FPG

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

    Time frame: week 0, week 12

    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.

  5. Change in Body Weight

    Time frame: week 0, week 12

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

    Time frame: week 0, week 12

    Change in TC

  7. Fasting Lipid Profile - Change in LDL-C

    Time frame: week 0, week 12

    Change in LDL-C

  8. Fasting Lipid Profile - Change in HDL-C

    Time frame: week 0, week 12

    Change in HDL-C

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

    Time frame: week 0, week 12

    Change in TG

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

    Time frame: week 0, week 12

    Change in TNF-alpha

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

    Time frame: week 0, week 12

    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).

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

    Time frame: week 0, week 12

    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).

  13. Number of Hypoglycaemic Episodes

    Time frame: weeks 0-12

    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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus: A 12-week Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial With an Open-label Glimepiride Arm

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 21, 2008
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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