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

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening.

Patients whose diabetes management consists of diet and exercise will also be eligible for this study.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 156 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Subjects with type 2 diabetes. Treated with diet and exercise alone or with metformin for at least 3 months prior to screening. BMI 27-45 kg/m\^2.

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

How the Study Was Run

The set-up was 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.

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 2002-08 with completion listed for 2003-05.

It ran at 33 sites in United States (33).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 (time frame: Baseline (Day 1) to Day 28).

It also tracked 3 secondary outcomes, for example Change in HbA1c from Baseline to Day 14, Change in fasting plasma glucose from Baseline to Day 14 and to Day 28 and Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 156 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.