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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Open-Label Study to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety of AC2993 Given Two Times a Day to Subjects With Type 2 Diabetes Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044668
• Other study ID #: 2993-117
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2002
• Last updated: February 19, 2015
• Start date: August 2002
• Est. completion date: September 2005

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• AC2993
Subjects will receive 5 µg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 µg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.

Locations

Country	Name	City	State
Hungary	Diagnostic Units Hungary Kft.	Budapest
Hungary	Peterfy Teaching Hospital	Budapest
Hungary	Uzsoki Street Municipal Hospital	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit	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)	Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52	No
Primary	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	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)	Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52	No