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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00620282
• Date of registration: 11/02/2008
• Primary sponsor: Novo Nordisk
• Public title: The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
• Scientific 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
• Date of first enrolment: February 2008
• Target sample size: 49
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00620282
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jason Brett, MD
• Affiliation: Novo Nordisk

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 2

Intervention(s)

Drug: glimepiride

Drug: liraglutide

Drug: placebo

Primary Outcome(s)

Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF) [Time Frame: week 0, week 12]

Secondary Outcome(s)

Biomarkers of Cardiovascular Risk - Change in TNF-alpha [Time Frame: week 0, week 12]

Change in Body Weight [Time Frame: week 0, week 12]

Change in Fasting Plasma Glucose (FPG) [Time Frame: week 0, week 12]

Change in HbA1c (Glycosylated Haemoglobin A1c) [Time Frame: week 0, week 12]

Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles [Time Frame: week 0, week 12]

Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF) [Time Frame: week 0, week 12]

Fasting Lipid Profile - Change in HDL-C [Time Frame: week 0, week 12]

Fasting Lipid Profile - Change in LDL-C [Time Frame: week 0, week 12]

Fasting Lipid Profile - Change in Total Cholesterol (TC) [Time Frame: week 0, week 12]

Fasting Lipid Profile - Change in Triglycerides (TG) [Time Frame: week 0, week 12]

Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range [Time Frame: week 0, week 12]

Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range [Time Frame: week 0, week 12]

Number of Hypoglycaemic Episodes [Time Frame: weeks 0-12]

Secondary ID(s)

NN2211-1799

Source(s) of Monetary Support

Please refer to primary and secondary sponsors