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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lira 1.8

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)

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Glimepiride

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

Group Type ACTIVE_COMPARATOR

glimepiride

Intervention Type DRUG

Tablets, 1 - 4 mg daily

Interventions

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liraglutide

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

glimepiride

Tablets, 1 - 4 mg daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No