A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

What Was Tested

This registered phase 3 trial tested Exenatide.

These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

691 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: Have been diagnosed with type 2 diabetes. Have a body mass index (BMI) of \>21 kg/m2 and \<35 kg/m2, inclusive.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: have any contraindication for the oad(s) that they use; have a known allergy or hypersensitivity to exenatide bid, exenatide qw, or excipients contained in these agents; have been treated for \>2 weeks with any of the following excluded medications within 90 days prior to study start:.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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 2009-07 with completion listed for 2010-09.

It ran at 42 sites in Japan (16), India (12), Taiwan (6), China (5) and South Korea (3).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 9 secondary outcomes, for example Change in Fasting Serum Glucose (FSG) From Baseline to Week 26, Change in Body Weight (BW) From Baseline to Week 26, Change in Total Cholesterol (TC) From Baseline to Week 26, Change in High-Density Lipoprotein (HDL) From Baseline to Week 26, Ratio of Triglycerides (TG) at Week 26 to Baseline and Change in Blood Pressure From Baseline to Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 691 people.

With 691 participants it is a large trial for this field.

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.