Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Exenatide.

Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.

It had four arms (groups): one (experimental), one (experimental), one (placebo comparator) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 734 actual participants took part.

It was open to people of any sex aged from 16 years up to 75 years.

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

Examples of who could join: Subjects with Type 2 diabetes mellitus. BMI= 27-45 kg/m2.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening; patients treated previously with ac2993; patients presently treated with insulin.

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.

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

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 2002-05 with completion listed for 2003-08.

It ran at 100 sites in United States (100).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c from Baseline to Week 30 (time frame: Baseline (Day 1) to Week 30).

It also tracked 6 secondary outcomes, for example Change in HbA1c from baseline (Day 1) to each of the intermediate visits and Change in body weight from Baseline to each intermediate visit and Week 30.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 734 people.

With 734 participants it is a large trial for this field.

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.