Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

NCT00324363 · Completed

Last updated 2026-05-28

This clinical trial tested whether the medication exenatide, when added to metformin or metformin and sulfonylureas, could better lower blood sugar levels in adults with type 2 diabetes compared to a placebo.

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 466 people

Who can join Ages 21–75 · all sexes

Timeline Started 2006-01 · est. completion 2007-04

Where 14 sites · China, India, South Korea, Taiwan

What this study is testing ClinicalTrials.gov NCT00324363 ↗

Description as written by the study sponsor.

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.

Treatments tested

exenatide also known as Byetta Drug

subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks
Placebo Drug

subcutaneous injection twice daily in volumes equal to exenatide

Main thing measured	To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00324363 ↗