Effect on Weight Loss of Exenatide Versus Placebo

What Was Tested

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

This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss.

This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea.

Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.

It had two arms (groups): Group A (experimental) and Group B (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 196 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: Diagnosed with type 2 diabetes for at least 6 months. Have a Body Mass Index (BMI) of 25 kg/m\^2 to 39.9 kg/m\^2, inclusive.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: have conditions contraindicating metformin and/or sulfonylurea use; have had a change in lipid-lowering agents within 6 weeks of screening; have received glucagon-like peptide-1 (glp-1) analogs, or dipeptidyl peptidase-iv inhibitors (dpp-iv inhibitors) or have previously participated in this study.

How the Study Was Run

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

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

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

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2006-09 with completion listed for 2008-02.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Body Weight (time frame: Baseline, Week 24).

It also tracked 11 secondary outcomes, for example Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24, Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24, Change From Baseline in Waist Circumference at Week 24, Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline, Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline and Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 196 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.