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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Glimepiride; Liraglutide

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