An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 3) is built around Exenatide.

This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.

It had three arms (groups): Exenatide Arm (experimental), Exenatide plus Rosiglitazone Arm (experimental) and Rosiglitazone Arm (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 137 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Body mass index (BMI) of 25 kg/m\^2 to 40 kg/m\^2, inclusive.

The full record lists 2 inclusion and 16 exclusion criteria; among the exclusions: have participated in this study previously, or have received exenatide, pramlintide acetate, glp-1 analogs, or dipeptidyl peptidase-iv (dpp-iv) inhibitors; treated with any of the following medications:; thiazolidinedione within 5 months of screening;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

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

Being open-label, the Exenatide study did not mask who received what.

It started in 2005-10 with completion listed for 2008-07.

It ran at 19 sites in United States (19).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in ASIiAUC During a Hyperglycemic Clamp Test (time frame: 20 weeks).

It also tracked 28 secondary outcomes, for example Change in AUC for Glucose During a Meal Challenge Test (MCT), Change in Insulin Sensitivity Index as Measured by M-value, Change in Insulin AUC in the First Stage From Baseline to Endpoint, Change in Insulin iAUC From Baseline to Endpoint, Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT) and Change in AUC for C-peptide During a Meal Challenge Test (MCT).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 137 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, all human trials.