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

What Was Tested

This registered phase 3 trial tested Exenatide.

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

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

After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.

The registry classes the interventions as drug.

Who Took Part

182 actual participants took part.

It was open to people of any sex aged from 21 years up to 75 years.

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

Examples of who could join: Body mass index (BMI) between 25 kg/m\^2 and 45 kg/m\^2.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: patient previously in a study using exenatide or glp-1 analogs; treated with oral anti-diabetic medications other than tzd and metformin within 3 months of screening; treated with oral insulin within 3 months of screening.

How the Study Was Run

Design: 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.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2004-05 with completion listed for 2005-08.

It ran at 51 sites in United States (40), Canada (6) and Spain (5).

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 16, and if measured, any visits in between (time frame: Baseline, Week 4, Week 8, Week 12, Week 16). Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose (time frame: Baseline, Week 16).

It also tracked 5 secondary outcomes, for example Change in body weight from Baseline to Week 16, Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose, Changes in beta cell function and insulin sensitivity between Baseline and Week 16 and Changes in lipids between Baseline and Week 16.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 182 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.