Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: AC2993

• Registration Number: NCT00044668
• Lead Sponsor: AstraZeneca

Brief Summary

This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2002-09-03
• Study First Submitted QC: 2002-09-04
• Study First Posted: 2002-09-05
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• Subjects with type 2 diabetes
• Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination
• BMI 25-45 kg/m^2
• HbA1c between 7.5 % and 12.0 %, inclusive

Exclusion Criteria

• Treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening
• Patients previously treated with AC2993
• Patients presently treated with insulin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AC2993	AC2993	5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit	Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52	Change in HbA1c from Baseline to Week 24, Week 52, and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit	Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52	Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Visit 10 (Week 24), to Visit 14 (Week 52) and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)

Trial Locations

Locations (3)

Uzsoki Street Municipal Hospital; 🇭🇺 Budapest, Hungary

Peterfy Teaching Hospital; 🇭🇺 Budapest, Hungary

Diagnostic Units Hungary Kft.; 🇭🇺 Budapest, Hungary