Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

What Was Tested

This registered phase 3 trial tested Exenatide.

It had two arms (groups): Exenatide twice daily (BID) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 165 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. Have a body mass index (BMI): 25 kg/m2 \< BMI \< 45 kg/m2.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening; used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening; are currently treated with any of the following excluded medications:.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2008-01 with completion listed for 2009-07.

It ran at 25 sites in United States (7), Romania (6), Canada (5), Mexico (5) and South Africa (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Hemoglobin (HbA1c) (time frame: baseline and 26 weeks).

It also tracked 10 secondary outcomes, for example Change in Fasting Serum Glucose (FSG), Change in Body Weight, Change in Waist Circumference, Change in Beta-cell Function, Change in Insulin Sensitivity and Number of Subjects Who Experienced an Episode of Minor Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 165 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.