Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Exenatide and Liraglutide.

This trial is conducted in Europe and the United States of America (USA).

The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes.

Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

It had two arms (groups): Liraglutide (experimental) and Exenatide (active comparator).

The registry classes the interventions as drug.

Who Took Part

467 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Type 2 diabetes. Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator. Body Mass Index (BMI) equal to or lower than 45.0 kg/m2.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: previous treatment with insulin; treatment with any anti-diabetic drug other than metformin and sulphonylurea; any previous exposure to exenatide or liraglutide.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-08 with completion listed for 2008-04.

It ran at 125 sites in United States (61), Germany (14), Poland (9), Denmark (5), France (5) and Norway (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated A1c (HbA1c) at Week 26 (time frame: week 0, week 26).

It also tracked 54 secondary outcomes, for example Change in Glycosylated A1c (HbA1c), Weeks 26-78, Change in Glycosylated A1c (HbA1c) at Week 78, Change in Body Weight at Week 26, Change in Body Weight, Weeks 26-78, Change in Body Weight at Week 78 and Change in Fasting Plasma Glucose at Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Liraglutide in 467 people.

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

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