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

Phase 3CompletedNCT00620282

Novo Nordisk A/S49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

liraglutideDRUG

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

placeboDRUG

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

glimepirideDRUG

Tablets, 1 - 4 mg daily

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

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

Change in HbA1c (Glycosylated Haemoglobin A1c)

Percentage point change in HbA1c

Time frame: week 0, week 12

Change in Fasting Plasma Glucose (FPG)

Change in FPG

Time frame: week 0, week 12

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

Change in Body Weight

Time frame: week 0, week 12

Fasting Lipid Profile - Change in Total Cholesterol (TC)

Change in TC

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.