Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

What Was Tested

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

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.

It had three arms (groups): Exenatide once weekly suspension (experimental), one (active comparator) and Placebo (placebo comparator).

Placebo oral capsule once daily.

The registry classes the interventions as drug.

Who Took Part

The registry lists 365 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: At least 18 years old. Diagnosed with type 2 diabetes mellitus. Body mass index of \<45 kg/m2 at screening.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either; active cardiovascular disease; presence or history of severe congestive heart failure.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

The Exenatide group and the comparison group ran side by side rather than switching.

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

It started in 2013-02 with completion listed for 2014-04.

It ran at 60 sites in United States (60).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 (time frame: Baseline to Week 28).

It also tracked 4 secondary outcomes, for example Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28, Change in Body Weight (kg) From Baseline to Week 28 and Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 365 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.