Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

What Was Tested

The trial (phase 4) is built around Exenatide.

This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione \[TZD\]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.

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 83 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: Have type 2 diabetes. Are between 18 and 70 years of age, inclusive. Have body mass index ≥25 kg/m2 and ≤45 kg/m2. Can swallow oral study drug capsule, without splitting or crushing.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:; are breastfeeding; test positive for pregnancy at the time of screening.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

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 2008-08 with completion listed for 2009-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Time-averaged Glucose During a 24 Hour Period (time frame: baseline and 8 Weeks).

It also tracked 18 secondary outcomes, for example Change in Two-hour Postprandial Glucose After the Morning Meal, Change in Fasting Blood Glucose After the Morning Meal, Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal, Change in Postprandial Glucagon AUC Excursion After the Morning Meal, Change in Postprandial Triglyceride AUC After the Morning Meal and Change in Postprandial Triglyceride AUC Excursion After the Morning Meal.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 83 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.