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

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035984
• Other study ID #: 2993-115
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2002
• Last updated: February 23, 2015
• Start date: May 2002
• Est. completion date: August 2003

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 734
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects with Type 2 diabetes mellitus

• Treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening

• BMI= 27-45 kg/m2

• HbA1c value between 7.5% and 11%

Exclusion Criteria:

• Treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening

• Patients treated previously with AC2993

• Patients presently treated with insulin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Intervention

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
• 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
• 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
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

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Pinnacle Research Group	Anniston	Alabama
United States	Israel A. Hartman, M.D.	Arlington	Texas
United States	Medical Associates of Northern Virginia	Arlington	Virginia
United States	Medical Research Unlimited	Aventura	Florida
United States	University of Maryland-Joslin Diabetes Center	Baltimore	Maryland
United States	University Primary Care Center at Belvidere	Belvidere	Illinois
United States	Parkway Medical Center	Birmingham	Alabama
United States	SUNY Downstate	Brooklyn	New York
United States	Mercury Street Medical	Butte	Montana
United States	Physicians for Clinical Research	Camp Hill	Pennsylvania
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Charlotte Clinical Research	Charlotte	North Carolina
United States	CNS Clinical Trials	Chester	South Carolina
United States	Diabetes and Endocrinology Specialists	Chesterfield	Missouri
United States	Cook County Hospital	Chicago	Illinois
United States	Illinois Center for Clinical Trials	Chicago	Illinois
United States	Northwestern Memorial Physicians Group	Chicago	Illinois
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Morton Plant Mease Health Care	Clearwater	Florida
United States	Columbus Metabolic Foundation	Columbus	Georgia
United States	Radiant Research-Columbus	Columbus	Ohio
United States	East Bay Clinical Trial Center	Concord	California
United States	Dallas Diabetes and Endocrinology Research Center	Dallas	Texas
United States	Creekside Endocrine Associates	Denver	Colorado
United States	University of Colorado-Barbara Davis Center for Childhood Diabetes	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	UNC Diabetes Care Center	Durham	North Carolina
United States	Texas Tech University Health Sciences-Internal Medicine	El Paso	Texas
United States	Medical Group of Encino	Encino	California
United States	University of Hawaii-Diabetes Research Group	Ewa Beach	Hawaii
United States	Medical Arts Research Collaborative	Excelsior Springs	Missouri
United States	First Care Family Doctors	Fayetteville	Arkansas
United States	Valley Research	Fresno	California
United States	Internal Medicine Associates	Ft. Myers	Florida
United States	St. Joseph Heritage Healthcare	Fullerton	California
United States	Clin Sci International	Gainesville	Florida
United States	Grand Rapids Associated Interns	Grand Rapids	Michigan
United States	Unifour Medical Research	Hickory	North Carolina
United States	American Health Network	Indianapolis	Indiana
United States	Indiana University Outpatient Clinical Research	Indianapolis	Indiana
United States	North Texas Clinical Research	Irving	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Northeast Florida Endocrine & Diabetes Research	Jacksonville	Florida
United States	Jupiter Research Institute	Jupiter	Florida
United States	Lipid, Atherosclerosis & Metabolic Clinic	Kansas City	Kansas
United States	St Lukes Lipid and Diabetes Research Center	Kansas City	Missouri
United States	Holston Medical Group	Kingsport	Tennessee
United States	Whittier Institute for Diabetes	La Jolla	California
United States	Lovelace Scientific Resources-Las Vegas	Las Vegas	Nevada
United States	Central Kentucky Research Associates	Lexington	Kentucky
United States	Kentucky Diabetes Center	Lexington	Kentucky
United States	University of Kentucky Metabolic Research Group	Lexington	Kentucky
United States	Physicians Group Research Clinic, LLC	Little Rock	Arkansas
United States	Richard Cherlin, M.D.	Los Gatos	California
United States	MedResearch, Inc.	Louisville	Kentucky
United States	University of Wisconsin West Clinic	Madison	Wisconsin
United States	Medford Medical Clinic	Medford	Oregon
United States	The Endocrine Clinic	Memphis	Tennessee
United States	University Mednet	Mentor	Ohio
United States	Baptist Diabetes Associates	Miami	Florida
United States	Midwest Endocrinology Associates	Milwaukee	Wisconsin
United States	International Diabetes Center	Minneapolis	Minnesota
United States	Extended Arm Physicians/ Southern Drug	Montgomery	Alabama
United States	Dr. Martinez Medical Clinic	Moreno Valley	California
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Mid State Endocrine Associates	Nashville	Tennessee
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	Ochsner Clinic	New Orleans	Louisiana
United States	St. Lukes Roosevelt Hospital	New York	New York
United States	OU Health Sciences Center	Oklahoma City	Oklahoma
United States	West Olympia Internal Medicine	Olympia	Washington
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Philadelphia Health Associates	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Diabetes Research Center	Philadelphia	Pennsylvania
United States	Radiant Research	Portland	Oregon
United States	Comprehensive Diabetes-Endocrine Medical Associates	Redwood City	California
United States	Lisa Abbott, MD	Reno	Nevada
United States	Rochester Clinical Research	Rochester	New York
United States	Mid Missouri Research Specialists, Inc.	Rolla	Missouri
United States	Salt Lake Research	Salt Lake City	Utah
United States	Utah Diabetes Center at the University of Utah	Salt Lake City	Utah
United States	Diabetes and Glandular Disease Clinic	San Antonio	Texas
United States	SAM Clinical Research	San Antonio	Texas
United States	University of Texas Health Sciences Center-Texas Diabetes Institute	San Antonio	Texas
United States	Radiant Research-San Diego	San Diego	California
United States	Veterans Medical Research Foundation	San Diego	California
United States	Comprehensive NeuroScience Inc.	Sarasota	Florida
United States	Rockwood Clinic	Spokane	Washington
United States	Radiant Research-St. Louis	St. Louis	Missouri
United States	Midwest Pharmaceutical Research	St. Peters	Missouri
United States	Tallahassee Endocrine Associates	Tallahassee	Florida
United States	Southern Drug Research Network	Tallassee	Alabama
United States	Diablo Clinical Research	Walnut Creek	California
United States	Clinica Research Inc.	Waltham	Massachusetts
United States	George Washington University	Washington	District of Columbia
United States	Medstar Clinical Research	Washington	District of Columbia
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	New Hanover Medical Research Associates	Wilmington	North Carolina
United States	DOCS at Beth Israel Medical Center	Yonkers	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005 May;28(5):1083- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from Baseline to Week 30	Change in HbA1c from Baseline (Day 1) to study termination (Week 30)	Baseline (Day 1) to Week 30	No
Secondary	Change in HbA1c from baseline (Day 1) to each of the intermediate visits	Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24)	Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24	No
Secondary	The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30	The number of subjects achieving HbA1c target values of < 7% and < 8% by study termination (Week 30)	Baseline (Day 1) and Week 30	No
Secondary	The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30	The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by study termination (Week 30)	Baseline (Day 1), and Week 30	No
Secondary	The time to achieve specific HbA1c target values of < 7% and < 8%	The time it takes subjects to achieve HbA1c target values of < 7% and < 8%	Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30	No
Secondary	The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more	The time it takes subjects to achieve HbA1c reductions of 0.5% or more and >1.0% or more	Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30	No
Secondary	Change in body weight from Baseline to each intermediate visit and Week 30	Change in body weight (kg) from Baseline to each intermediate visit and Week 30	Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30	No