Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

What Was Tested

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

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 1029 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Diagnosed with type 2 diabetes mellitus. Body Mass Index (BMI) \>=25 kg/m\^2 and \<40 kg/m\^2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: characteristics contraindicating metformin or glimepiride use; receiving drugs that directly affect gastrointestinal motility; receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2006-09 with completion listed for 2011-03.

It ran at 114 sites in Italy (23), Germany (19), France (17), United Kingdom (12), Czechia (7) and Poland (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Patients With Treatment Failure (time frame: Baseline to end of Period II (up to 4.5 years)). Time to Treatment Failure (time frame: Baseline to end of Period II (up to 4.5 years)).

It also tracked 25 secondary outcomes, for example Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3, Change in HOMA-B From Baseline to Endpoint, Fasting Proinsulin/Insulin Ratio at Year 3, Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint, Change in DI30/DG30 Ratio From Baseline to Endpoint and Disposition Index at Year 3.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 1029 people.

With 1029 participants it is a large trial for this field.

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

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