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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide; Drug: placebo; Drug: glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620282

NN2211-1799

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 3 patient groups, including a placebo group

Lira 1.8

Experimental group

Description:

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)

Treatment:

Drug: liraglutide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Glimepiride

Active Comparator group

Description:

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

Treatment:

Drug: glimepiride