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

What Was Tested

The trial (phase 3) is built around Liraglutide.

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.

It had three arms (groups): Lira 1.8 (experimental), Placebo (placebo comparator) and Glimepiride (active comparator).

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 49 actual participants took part.

It was open to people of any sex aged from 40 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 diabetes. Diet and lifestyle changes or metformin monotherapy for at least three months. Body Mass Index (BMI) less than or equal to 40 kg/m\^2.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-02 with completion listed for 2010-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF) (time frame: week 0, week 12).

It also tracked 13 secondary outcomes, for example Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF), Change in HbA1c (Glycosylated Haemoglobin A1c), Change in Fasting Plasma Glucose (FPG), Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles, Change in Body Weight and Fasting Lipid Profile - Change in Total Cholesterol (TC).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 49 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.