Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Interventions
- Drug: Placebo
- Registration Number
- NCT00035984
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 734
- 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%
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AC2993 5 mcg (0.02 mL) AC2993 Placebo, then AC2993 5 mcg, then AC2993 5 mcg AC2993 10mcg (0.04 mL) AC2993 Placebo, then AC2993 5 mcg, then AC2993 10 mcg Placebo 0.02 mL Placebo Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL Placebo 0.04 mL Placebo Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL
- Primary Outcome Measures
Name Time Method Change in HbA1c from Baseline to Week 30 Baseline (Day 1) to Week 30 Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
- Secondary Outcome Measures
Name Time Method Change in HbA1c from baseline (Day 1) to each of the intermediate visits Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24 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)
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30 Baseline (Day 1) and Week 30 The number of subjects achieving HbA1c target values of \< 7% and \< 8% by study termination (Week 30)
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30 Baseline (Day 1), and Week 30 The number of subjects achieving HbA1c reductions of \> 0.5% and \> 1.0% by study termination (Week 30)
The time to achieve specific HbA1c target values of < 7% and < 8% Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30 The time it takes subjects to achieve HbA1c target values of \< 7% and \< 8%
The time 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 The time it takes subjects to achieve HbA1c reductions of 0.5% or more and \>1.0% or more
Change in body weight 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 Change in body weight (kg) from Baseline to each intermediate visit and Week 30
Trial Locations
- Locations (100)
Diabetes and Endocrinology Specialists
🇺🇸Chesterfield, Missouri, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Radiant Research-San Diego
🇺🇸San Diego, California, United States
Veterans Medical Research Foundation
🇺🇸San Diego, California, United States
Baptist Diabetes Associates
🇺🇸Miami, Florida, United States
Indiana University Outpatient Clinical Research
🇺🇸Indianapolis, Indiana, United States
UNC Diabetes Care Center
🇺🇸Durham, North Carolina, United States
Utah Diabetes Center at the University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Texas Health Sciences Center-Texas Diabetes Institute
🇺🇸San Antonio, Texas, United States
SAM Clinical Research
🇺🇸San Antonio, Texas, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
First Care Family Doctors
🇺🇸Fayetteville, Arkansas, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Whittier Institute for Diabetes
🇺🇸La Jolla, California, United States
Medical Research Unlimited
🇺🇸Aventura, Florida, United States
Morton Plant Mease Health Care
🇺🇸Clearwater, Florida, United States
Northwestern Memorial Physicians Group
🇺🇸Chicago, Illinois, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Jupiter Research Institute
🇺🇸Jupiter, Florida, United States
Kentucky Diabetes Center
🇺🇸Lexington, Kentucky, United States
University of Hawaii-Diabetes Research Group
🇺🇸Ewa Beach, Hawaii, United States
Central Kentucky Research Associates
🇺🇸Lexington, Kentucky, United States
OU Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Thomas Jefferson University Diabetes Research Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Colorado-Barbara Davis Center for Childhood Diabetes
🇺🇸Denver, Colorado, United States
Midwest Endocrinology Associates
🇺🇸Milwaukee, Wisconsin, United States
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Extended Arm Physicians/ Southern Drug
🇺🇸Montgomery, Alabama, United States
Southern Drug Research Network
🇺🇸Tallassee, Alabama, United States
Physicians Group Research Clinic, LLC
🇺🇸Little Rock, Arkansas, United States
St. Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
Medical Group of Encino
🇺🇸Encino, California, United States
Richard Cherlin, M.D.
🇺🇸Los Gatos, California, United States
Comprehensive Diabetes-Endocrine Medical Associates
🇺🇸Redwood City, California, United States
Creekside Endocrine Associates
🇺🇸Denver, Colorado, United States
Medstar Clinical Research
🇺🇸Washington, District of Columbia, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Northeast Florida Endocrine & Diabetes Research
🇺🇸Jacksonville, Florida, United States
Tallahassee Endocrine Associates
🇺🇸Tallahassee, Florida, United States
Columbus Metabolic Foundation
🇺🇸Columbus, Georgia, United States
University Primary Care Center at Belvidere
🇺🇸Belvidere, Illinois, United States
American Health Network
🇺🇸Indianapolis, Indiana, United States
Lipid, Atherosclerosis & Metabolic Clinic
🇺🇸Kansas City, Kansas, United States
University of Kentucky Metabolic Research Group
🇺🇸Lexington, Kentucky, United States
University of Maryland-Joslin Diabetes Center
🇺🇸Baltimore, Maryland, United States
Grand Rapids Associated Interns
🇺🇸Grand Rapids, Michigan, United States
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Clinica Research Inc.
🇺🇸Waltham, Massachusetts, United States
Mercury Street Medical
🇺🇸Butte, Montana, United States
Radiant Research-St. Louis
🇺🇸St. Louis, Missouri, United States
Midwest Pharmaceutical Research
🇺🇸St. Peters, Missouri, United States
Lovelace Scientific Resources-Las Vegas
🇺🇸Las Vegas, Nevada, United States
St. Lukes Roosevelt Hospital
🇺🇸New York, New York, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
DOCS at Beth Israel Medical Center
🇺🇸Yonkers, New York, United States
Charlotte Clinical Research
🇺🇸Charlotte, North Carolina, United States
Unifour Medical Research
🇺🇸Hickory, North Carolina, United States
New Hanover Medical Research Associates
🇺🇸Wilmington, North Carolina, United States
Radiant Research-Columbus
🇺🇸Columbus, Ohio, United States
Medford Medical Clinic
🇺🇸Medford, Oregon, United States
University Mednet
🇺🇸Mentor, Ohio, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Physicians for Clinical Research
🇺🇸Camp Hill, Pennsylvania, United States
Philadelphia Health Associates
🇺🇸Philadelphia, Pennsylvania, United States
CNS Clinical Trials
🇺🇸Chester, South Carolina, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
The Endocrine Clinic
🇺🇸Memphis, Tennessee, United States
Mid State Endocrine Associates
🇺🇸Nashville, Tennessee, United States
Israel A. Hartman, M.D.
🇺🇸Arlington, Texas, United States
Dallas Diabetes and Endocrinology Research Center
🇺🇸Dallas, Texas, United States
Texas Tech University Health Sciences-Internal Medicine
🇺🇸El Paso, Texas, United States
North Texas Clinical Research
🇺🇸Irving, Texas, United States
Medical Associates of Northern Virginia
🇺🇸Arlington, Virginia, United States
West Olympia Internal Medicine
🇺🇸Olympia, Washington, United States
Rockwood Clinic
🇺🇸Spokane, Washington, United States
University of Wisconsin West Clinic
🇺🇸Madison, Wisconsin, United States
Cook County Hospital
🇺🇸Chicago, Illinois, United States
Illinois Center for Clinical Trials
🇺🇸Chicago, Illinois, United States
Internal Medicine Associates
🇺🇸Ft. Myers, Florida, United States
Valley Research
🇺🇸Fresno, California, United States
East Bay Clinical Trial Center
🇺🇸Concord, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Medical Arts Research Collaborative
🇺🇸Excelsior Springs, Missouri, United States
Dr. Martinez Medical Clinic
🇺🇸Moreno Valley, California, United States
Comprehensive NeuroScience Inc.
🇺🇸Sarasota, Florida, United States
Lisa Abbott, MD
🇺🇸Reno, Nevada, United States
Mid Missouri Research Specialists, Inc.
🇺🇸Rolla, Missouri, United States
SUNY Downstate
🇺🇸Brooklyn, New York, United States
Diabetes and Glandular Disease Clinic
🇺🇸San Antonio, Texas, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
MedResearch, Inc.
🇺🇸Louisville, Kentucky, United States
St Lukes Lipid and Diabetes Research Center
🇺🇸Kansas City, Missouri, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Clin Sci International
🇺🇸Gainesville, Florida, United States
Radiant Research
🇺🇸Portland, Oregon, United States