NCT00035984

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

A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Twice Daily in Subjects With Type 2 Diabetes Mellitus Treated With Metformin and a Sulfonylurea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 734 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.

Conditions

• Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Type	Name	Description
DRUG	AC2993	Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
DRUG	AC2993	Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
DRUG	Placebo	Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
DRUG	Placebo	Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily

Timeline

• Start date: 2002-05-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2002-05-08
• Last updated: 2015-02-24

Locations

100 sites across 1 country: United States