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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039013
• Other study ID #: 2993-112
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2002
• Last updated: February 23, 2015
• Start date: March 2002
• Est. completion date: June 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 medication (metformin) throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: June 2003
• Est. primary completion date: June 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 metformin within a defined dose range 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 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, 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 / Placebo (0.02 mL) for 4 weeks / Placebo (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	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Pinnacle Research Group	Anniston	Alabama
United States	Central Texas Clinical Research	Austin	Texas
United States	Mitchell Research Group, Inc.	Bakersfield	California
United States	St. Agnes Health Care	Baltimore	Maryland
United States	University Primary Care Center at Belvidere	Belvidere	Illinois
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Parkway Medical Center	Birmingham	Alabama
United States	Grunberger Diabetes Medical Center	Bloomfield Hills	Michigan
United States	Medical Network Services, P.C.	Brooklyn	New York
United States	William Zigrang, M.D.	Burlingame	California
United States	Mercury Street Medical	Butte	Montana
United States	Physicians for Clinical Research	Camp Hill	Pennsylvania
United States	CAMC Clinical Trials Center	Charleston	West Virginia
United States	Hyperion Clinical Research	Charleston	West Virginia
United States	Radiant Research-Charleston	Charleston	South Carolina
United States	Charlotte Clinical Research	Charlotte	North Carolina
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	CNS Clinical Trials	Chester	South Carolina
United States	Diabetes and Endocrinology Specialists	Chesterfield	Missouri
United States	Illinois Center for Clinical Trials	Chicago	Illinois
United States	Northwestern Memorial Physicians Group	Chicago	Illinois
United States	International Clinical Research Network	Chula Vista	California
United States	Rapid Medical Research	Cleveland	Ohio
United States	Arrowhead Regional Medical Center	Colton	California
United States	Ohio State University-Division of Endocrinology	Columbus	Ohio
United States	Radiant Research-Columbus	Columbus	Ohio
United States	Rafael Canadas M.D., P.A.	Dallas	Texas
United States	nTouch Research Corporation	Decatur	Georgia
United States	Henry Ford Health System	Detroit	Michigan
United States	UNC Diabetes Care Center	Durham	North Carolina
United States	Safe Harbor Clinical Research	East Providence	Rhode Island
United States	Eclectic Family Care	Eclectic	Alabama
United States	Internal Medicine Associates	El Paso	Texas
United States	Texas Tech University Health Sciences-Internal Medicine	El Paso	Texas
United States	Medical Group of Fort Wayne	Fort Wayne	Indiana
United States	Valley Research	Fresno	California
United States	Internal Medical Associates	Ft. Myers	Florida
United States	Clin Sci International	Gainesville	Florida
United States	University of FL	Gainesville	Florida
United States	Grand Rapids Associated Interns	Grand Rapids	Michigan
United States	Winston Physician Services	Haleyville	Alabama
United States	Unifour Medical Research	Hickory	North Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Simon Williamson Clinic	Hueytown	Alabama
United States	American Health Network	Indianapolis	Indiana
United States	Center for Metabolic and Hormonal Disorders	Indianapolis	Indiana
United States	North Texas Clinical Research	Irving	Texas
United States	Integrity Clinical Research	Jackson	Tennessee
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	HIS Clinical Research	Jersey City	New Jersey
United States	Harmony Clinical Research	Johnson City	Tennessee
United States	Jupiter Research Institute	Jupiter	Florida
United States	Holston Medical Group	Kingsport	Tennessee
United States	Dr. Humberto Bruschetta	Kingsville	Texas
United States	Evergreen Diabetes & Endocrinology	Kirkland	Washington
United States	Endocrine Consultants of ET	Knoxville	Tennessee
United States	Doctors Research Associates of Maryland	Lanham	Maryland
United States	Lovelace Scientific Resources-Las Vegas	Las Vegas	Nevada
United States	Kentucky Diabetes Center	Lexington	Kentucky
United States	University of Kentucky Metabolic Research Group	Lexington	Kentucky
United States	Lake Forest Internal Medicine	Libertyville	Illinois
United States	Winchester Research Group	Libertyville	Illinois
United States	CAVHS	Little Rock	Arkansas
United States	Physicians Group Research Clinic, LLC	Little Rock	Arkansas
United States	MedResearch, Inc.	Louisville	Kentucky
United States	South Texas Applied Research	McAllen	Texas
United States	Medford Medical Clinic	Medford	Oregon
United States	University Mednet	Mentor	Ohio
United States	St. Luke's Family Health	Meridian	Idaho
United States	ANA Ventures, LLC	Mesa	Arizona
United States	Clinic of Physicians and Surgeons, Ltd.	Mesa	Arizona
United States	Drug Research Services	Metairie	Louisiana
United States	Baptist Diabetes Associates	Miami	Florida
United States	Extended Arm Physicians/ Southern Drug	Montgomery	Alabama
United States	Radiant Research-Moorestown	Moorestown	New Jersey
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	New Orleans Institute of Clinical Investigation	New Orleans	Louisiana
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Heights Medical Care	New York	New York
United States	Naomi Berrie Diabetes Center at Columbia University	New York	New York
United States	St. Lukes Roosevelt Hospital	New York	New York
United States	COR Clinical Research	Oklahoma City	Oklahoma
United States	nTouch Research Corporation-Oklahoma City	Oklahoma City	Oklahoma
United States	West Olympia Internal Medicine	Olympia	Washington
United States	New Jersey Physicians	Passaic	New Jersey
United States	Philadelphia Health Associates	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Diabetes Research Center	Philadelphia	Pennsylvania
United States	Lovelace Scientific Resources-Phoenix	Phoenix	Arizona
United States	Physicians at the Peak	Phoenix	Arizona
United States	Legacy Clinical Research	Portland	Oregon
United States	Radiant Research	Portland	Oregon
United States	Elke Jost-Vu, M.D.	Rancho Mirage	California
United States	Comprehensive Diabetes-Endocrine Medical Associates	Redwood City	California
United States	Rainier Clinical Research Center	Renton	Washington
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	Diabetes and Glandular Disease Clinic	San Antonio	Texas
United States	SAM Clinical Research Center	San Antonio	Texas
United States	University of Texas Health Sciences Center-Texas Diabetes Institute	San Antonio	Texas
United States	nTouch	San Diego	California
United States	Radiant Research-San Diego	San Diego	California
United States	Veterans Medical Research Foundation	San Diego	California
United States	Diabetes Research Institute of Mills Peninsula	San Mateo	California
United States	Advanced Clinical Research Institute	Santa Ana	California
United States	West Coast Clinical Trials	Signal Hill	California
United States	nTouch Research-South Bend	South Bend	Indiana
United States	Julia M. Hutchinson, M.D.	Spokane	Washington
United States	Northside Internal Medicine	Spokane	Washington
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	Southern Drug Research Network	Tallassee	Alabama
United States	Tampa Medical Group	Tampa	Florida
United States	Tipton Medical and Diagnostic Center	Tipton	Pennsylvania
United States	Advanced Clinical Therapeutics	Tucson	Arizona
United States	Utica Park Clinic	Tulsa	Oklahoma
United States	Protocare Trials at Sharp Mission Park	Vista	California
United States	Diablo Clinical Research	Walnut Creek	California
United States	George Washington University	Washington	District of Columbia
United States	Medstar Clinical Research	Washington	District of Columbia
United States	Wenatchee Valley Clinic	Wenatchee	Washington
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	Radiant Research	West Palm Beach	Florida
United States	New Hanover Medical Research Associates	Wilmington	North Carolina
United States	Piedmont Medical Research	Winston-Salem	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 (2)

DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005 May;28(5):1092-100. — View Citation

Ratner RE, Maggs D, Nielsen LL, Stonehouse AH, Poon T, Zhang B, Bicsak TA, Brodows RG, Kim DD. Long-term effects of exenatide therapy over 82 weeks on glycaemic control and weight in over-weight metformin-treated patients with type 2 diabetes mellitus. Di — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30)	Change in HbA1c from from baseline, measured from Visit 3 (Day 1) to study termination (Week 30).	Baseline (Day 1), 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