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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00035984
Other study ID # 2993-115
Secondary ID
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


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
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