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

Study identifier:2993-112

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 Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With Metformin Alone

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 3

Healthy volunteers

Study drug

AC2993, Placebo

Sex

All

Actual Enrollment

336

Study type

Interventional

Age

16 Years - 75 Years

Date

Study Start Date: 01 Mar 2002

Primary Completion Date: 01 Jun 2003

Study Completion Date: 01 Jun 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

Collaborators

Inclusion and exclusion criteria

Location

Advanced Clinical Therapeutics

Tucson, AZ, United States, 85712

Location

Alabama Clinical Therapeutics

Birmingham, AL, United States, 35235

Location

American Health Network

Indianapolis, IN, United States, 46222

Location

ANA Ventures, LLC

Mesa, AZ, United States, 85204

Location

Arrowhead Regional Medical Center

Colton, CA, United States, 92324

Location

Baptist Diabetes Associates

Miami, FL, United States, 33176

Location

CAMC Clinical Trials Center

Charleston, WV, United States, 25304

Location

CAVHS

Little Rock, AR, United States, 72205

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 / Placebo (0.02 mL) for 4 weeks / Placebo (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 Treated With Metformin

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 Therapeutics

Alabama Clinical Therapeutics

American Health Network

ANA Ventures, LLC

Arrowhead Regional Medical Center

Baptist Diabetes Associates

CAMC Clinical Trials Center

CAVHS

Documents available

Link to study results on ClinicalStudyResults.org

Trial Results Summaries

Contacts

Contact