Safety and Efficacy of Exenatide as Monotherapy

What Was Tested

The trial (phase 3) is built around Exenatide.

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.

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

Placebo in volumes equivalent to exenatide.

The registry classes the interventions as drug.

Who Took Part

233 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Diagnosed with type 2 diabetes. Treating diabetes with diet and exercise. Body Mass Index (BMI) between 25 kg/m\^2 and 45 kg/m\^2, inclusive.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: have previously completed or withdrawn from this study; have been treated with any antidiabetic agent; have used drugs for weight loss (for example, xenical, meridia, acutrim, or similar over-the counter medications) within 3 months of screening.

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 2006-09 with completion listed for 2007-09.

It ran at 19 sites in India (7), Romania (6), United States (2), Puerto Rico (2) and Russia (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24 (time frame: Baseline, Week 24).

It also tracked 6 secondary outcomes, for example Change in fasting serum glucose (FSG) from Baseline to Week 24, Change in body weight from Baseline to Week 24, Change in glucose measurements from Baseline to Week 24, Changes in beta-cell function and insulin sensitivity from Baseline to Week 24 and Changes in fasting and 30, 60, 120 and 180-minute glucose measurements.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 233 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.