Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Exenatide.

It had four arms (groups): Group A1 (placebo comparator), Group A2 (placebo comparator), Group B (experimental) and Group C (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 45 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: Has type 2 diabetes treated with either: \*A stable regimen of metformin for a minimum of 3 months, and/or \*Diet modification and exercise for a minimum of 3 months. Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: received any investigational drug within 3 months prior to screening; participated previously in an exenatide clinical study.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant and investigator.

It started in 2005-02 with completion listed for 2005-10.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27) and Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 45 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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