Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Exenatide.

This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.

It had two arms (groups): 1 - exenatide before breakfast and dinner (experimental) and 2 - exenatide before lunch and dinner (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 377 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Diagnosed with type 2 diabetes. Body Mass Index (BMI) \> 25 kg/m\^2 and \< 45 kg/m\^2.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: have characteristics contraindicating metformin, su, or tzd use; have used any prescription drug to promote weight loss within 3 months prior to screening.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2006-09 with completion listed for 2007-07.

It ran at 15 sites in Brazil (9) and Mexico (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 (time frame: Baseline, Week 12).

It also tracked 3 secondary outcomes, for example Change in body weight from Baseline to Week 12, and if measured, at each visit, Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit and Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 377 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.