Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)
NCT00577824 · Completed
Last updated 2026-05-28This clinical trial tested the effects of the medication exenatide in Japanese adults with type 2 diabetes who were already taking oral diabetes medications.
Status Completed The study has finished.
Phase Phase 3 Confirms effectiveness in a large group before approval.
Type Interventional (clinical trial)
Design Randomized, double-blind treatment study
Participants 181 people
Who can join Ages 20–75 · all sexes
Timeline Started 2008-01 · est. completion 2008-11
Where 12 sites · Japan
What this study is testing ClinicalTrials.gov NCT00577824 ↗
Description as written by the study sponsor.
This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.
Treatments tested
- exenatide also known as LY2148568, Byetta Drug
subcutaneous injection, 5mcg, twice a day
- exenatide also known as LY2148568, Byetta Drug
subcutaneous injection, 10mcg, twice a day
- placebo Drug
subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day
| Main thing measured | Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 |
|---|---|
| Sponsor | AstraZeneca |
| Conditions studied | Type 2 Diabetes |
| GLP-1 drugs | exenatide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00577824 ↗