Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Exenatide.

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

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

It had two arms (groups): Exenatide once weekly suspension (experimental) and Exenatide twice daily (BID) (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 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 (BMI) \<=45 kg/m2, inclusive, at screening. Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either; active cardiovascular disease; presence of congestive heart failure.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-01 with completion listed for 2014-08.

It ran at 58 sites in United States (58).

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 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.

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; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.