Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

What Was Tested

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

It had three arms (groups): 1 (experimental), 2 (experimental) and 3 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 181 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

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

Examples of who could join: Diagnosed with type 2 diabetes. Have a body weight \>=50 kg.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (glp-1) analogs within the last 90 days; have been treated with any exogenous insulin within 90 days before study start; the combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

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

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 2008-01 with completion listed for 2008-11.

It ran at 12 sites in Japan (12).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 (time frame: baseline, 24 weeks).

It also tracked 16 secondary outcomes, for example Change in Fasting Blood Glucose, Change in Body Weight, Change in Total Cholesterol, Change in Low Density Lipoprotein Cholesterol (LDL-C), Change in High Density Lipoprotein Cholesterol (HDL-C) and Change in Triglycerides.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 181 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.