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

Study identifier:2993-115

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Diabetes Mellitus, Non-Insulin-Dependent

Phase

Phase 3

Healthy volunteers

Study drug

AC2993, Placebo

Sex

All

Actual Enrollment

734

Study type

Interventional

Age

16 Years - 75 Years

Date

Study Start Date: 01 May 2002

Primary Completion Date: 01 Aug 2003

Study Completion Date: 01 Aug 2003

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Advanced Clinical Research Institute

Anaheim, CA, United States, 92801

Location

Albert Einstein Medical Center

Philadelphia, PA, United States, 19141

Location

American Health Network

Indianapolis, IN, United States, 46222

Location

Baptist Diabetes Associates

Miami, FL, United States, 33176

Location

Central Kentucky Research Associates

Lexington, KY, United States, 40509

Location

Charlotte Clinical Research

Charlotte, NC, United States, 28211

Location

Clin Sci International

Gainesville, FL, United States, 32605

Location

Clinical Research of West Florida, Inc.

Clearwater, FL, United States, 33765

Arms	Assigned Interventions
Experimental: AC2993 5 mcg (0.02 mL) Placebo, then AC2993 5 mcg, then AC2993 5 mcg	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 Other Name: synthetic exendin-4
Experimental: AC2993 10mcg (0.04 mL) Placebo, then AC2993 5 mcg, then AC2993 10 mcg	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 Other Name: synthetic exendin-4
Placebo Comparator: Placebo 0.02 mL Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL	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
Placebo Comparator: Placebo 0.04 mL Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL	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

Documents available

Link to study results on ClinicalStudyResults.org
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center null

1-877-240-9479

information.center@astrazeneca.com

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Advanced Clinical Research Institute

Albert Einstein Medical Center

American Health Network

Baptist Diabetes Associates

Central Kentucky Research Associates

Charlotte Clinical Research

Clin Sci International

Clinical Research of West Florida, Inc.

Documents available

Link to study results on ClinicalStudyResults.org

Trial Results Summaries

Contacts

Contact