Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus

NCT00044694 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and effects of the medication AC2993 on blood sugar control in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 156 people

Who can join Ages 18–65 · all sexes

Timeline Started 2002-08 · est. completion 2003-05

Where 33 sites · United States

What this study is testing ClinicalTrials.gov NCT00044694 ↗

Description as written by the study sponsor.

This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.

Treatments tested

Placebo 0.01 mL Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
Placebo 0.02 mL Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
Placebo 0.03 mL Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
Placebo 0.04 mL Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
AC2993 2.5 mcg also known as synthetic exendin-4 Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
AC2993 5.0 mcg also known as synthetic exendin-4 Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
AC2993 7.5 mcg also known as synthetic exendin-4 Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
AC2993 10.0 mcg also known as synthetic exendin-4 Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily

Main thing measured	Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
Sponsor	AstraZeneca
Conditions studied	Diabetes Mellitus, Non-Insulin-Dependent
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00044694 ↗