A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide.

This purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.

It had two arms (groups): Sequence A (experimental) and Sequence B (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 102 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Treatment with metformin for at least 2 months. Body mass index (BMI)25 kg/m\^2 to 45 kg/m\^2, inclusive. List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:. Hormone replacement therapy (female subjects). Oral contraceptives (female subjects).

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: has been treated with exenatide (byetta®) or any dpp-4 inhibitor prior to screening; received any study medication or participated in any type of clinical trial within 30 days prior to screening; has donated blood within 60 days of screening visit or is planning to donate blood during the study.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2007-05 with completion listed for 2007-09.

It ran at 19 sites in United States (19).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of Exenatide on postprandial glucose (time frame: 28 days).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 102 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.