Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

What Was Tested

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

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

It had two arms (groups): exenatide once weekly (experimental) and insulin glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 427 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Present with type 2 diabetes mellitus. Body mass index (BMI) of \>18kg/m2 and \<35kg/m2, inclusive.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: have been treated with drugs that promote weight loss within 90 days prior to study start; have been treated with drugs that directly affect gastrointestinal motility for \> 21 consecutive days within 90 days prior to study start; have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.

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.

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 2009-07 with completion listed for 2010-09.

It ran at 22 sites in Japan (22).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c From Baseline to Endpoint (Week 26) (time frame: Baseline, Week 26).

It also tracked 10 secondary outcomes, for example Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26), Change in Body Weight From Baseline to Endpoint (Week 26), Change in Total Cholesterol From Baseline to Endpoint (Week 26), Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26), Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline and Change in Blood Pressure From Baseline to Endpoint (Week 26).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Glargine in 427 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 and the Insulin Glargine compound page, all human trials.