Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
- Registration Number
- NCT00039013
- 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 medication (metformin) throughout the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
- 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%
- 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
- 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 Placebo 0.02 mL Placebo Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL AC2993 10mcg (0.04 mL) AC2993 Placebo, then AC2993 5 mcg, then AC2993 10 mcg 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 (glycosylated hemoglobin) from baseline to study termination (Week 30) Baseline (Day 1), Week 30 Change in HbA1c from from baseline, measured from Visit 3 (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 (127)
Thomas Jefferson University Diabetes Research Center
🇺🇸Philadelphia, Pennsylvania, United States
Philadelphia Health Associates
🇺🇸Philadelphia, Pennsylvania, United States
St. Agnes Health Care
🇺🇸Baltimore, Maryland, United States
Ohio State University-Division of Endocrinology
🇺🇸Columbus, Ohio, United States
Radiant Research-Columbus
🇺🇸Columbus, Ohio, United States
nTouch
🇺🇸San Diego, California, United States
Veterans Medical Research Foundation
🇺🇸San Diego, California, United States
Baptist Diabetes Associates
🇺🇸Miami, Florida, United States
Center for Metabolic and Hormonal Disorders
🇺🇸Indianapolis, Indiana, United States
Lovelace Scientific Resources-Las Vegas
🇺🇸Las Vegas, Nevada, United States
University of Texas Health Sciences Center-Texas Diabetes Institute
🇺🇸San Antonio, Texas, United States
SAM Clinical Research Center
🇺🇸San Antonio, Texas, United States
UNC Diabetes Care Center
🇺🇸Durham, North Carolina, United States
Diabetes and Glandular Disease Clinic
🇺🇸San Antonio, Texas, United States
Mercury Street Medical
🇺🇸Butte, Montana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Lovelace Scientific Resources-Phoenix
🇺🇸Phoenix, Arizona, United States
Physicians at the Peak
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
nTouch Research Corporation-Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Simon Williamson Clinic
🇺🇸Hueytown, Alabama, United States
ANA Ventures, LLC
🇺🇸Mesa, Arizona, United States
Southern Drug Research Network
🇺🇸Tallassee, Alabama, United States
William Zigrang, M.D.
🇺🇸Burlingame, California, United States
International Clinical Research Network
🇺🇸Chula Vista, California, United States
Comprehensive Diabetes-Endocrine Medical Associates
🇺🇸Redwood City, California, United States
University of FL
🇺🇸Gainesville, Florida, United States
nTouch Research Corporation
🇺🇸Decatur, Georgia, United States
University Primary Care Center at Belvidere
🇺🇸Belvidere, Illinois, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Grunberger Diabetes Medical Center
🇺🇸Bloomfield Hills, Michigan, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Texas Tech University Health Sciences-Internal Medicine
🇺🇸El Paso, Texas, United States
Wenatchee Valley Clinic
🇺🇸Wenatchee, Washington, United States
Julia M. Hutchinson, M.D.
🇺🇸Spokane, Washington, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Legacy Clinical Research
🇺🇸Portland, Oregon, United States
Eclectic Family Care
🇺🇸Eclectic, Alabama, United States
Endocrine Consultants of ET
🇺🇸Knoxville, Tennessee, United States
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Winston Physician Services
🇺🇸Haleyville, Alabama, United States
Extended Arm Physicians/ Southern Drug
🇺🇸Montgomery, Alabama, United States
Clinic of Physicians and Surgeons, Ltd.
🇺🇸Mesa, Arizona, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
CAVHS
🇺🇸Little Rock, Arkansas, United States
Advanced Clinical Research Institute
🇺🇸Santa Ana, California, United States
Elke Jost-Vu, M.D.
🇺🇸Rancho Mirage, California, United States
Mitchell Research Group, Inc.
🇺🇸Bakersfield, California, United States
Valley Research
🇺🇸Fresno, California, United States
Protocare Trials at Sharp Mission Park
🇺🇸Vista, California, United States
West Coast Clinical Trials
🇺🇸Signal Hill, California, United States
Radiant Research-San Diego
🇺🇸San Diego, California, United States
Diabetes Research Institute of Mills Peninsula
🇺🇸San Mateo, California, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Clin Sci International
🇺🇸Gainesville, Florida, United States
Medstar Clinical Research
🇺🇸Washington, District of Columbia, United States
Internal Medical Associates
🇺🇸Ft. Myers, Florida, United States
Jupiter Research Institute
🇺🇸Jupiter, Florida, United States
Tampa Medical Group
🇺🇸Tampa, Florida, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Northwestern Memorial Physicians Group
🇺🇸Chicago, Illinois, United States
Illinois Center for Clinical Trials
🇺🇸Chicago, Illinois, United States
St. Luke's Family Health
🇺🇸Meridian, Idaho, United States
Lake Forest Internal Medicine
🇺🇸Libertyville, Illinois, United States
Winchester Research Group
🇺🇸Libertyville, Illinois, United States
Medical Group of Fort Wayne
🇺🇸Fort Wayne, Indiana, United States
American Health Network
🇺🇸Indianapolis, Indiana, United States
Kentucky Diabetes Center
🇺🇸Lexington, Kentucky, United States
nTouch Research-South Bend
🇺🇸South Bend, Indiana, United States
University of Kentucky Metabolic Research Group
🇺🇸Lexington, Kentucky, United States
MedResearch, Inc.
🇺🇸Louisville, Kentucky, United States
Drug Research Services
🇺🇸Metairie, Louisiana, United States
New Orleans Institute of Clinical Investigation
🇺🇸New Orleans, Louisiana, United States
Diabetes and Endocrinology Specialists
🇺🇸Chesterfield, Missouri, United States
Doctors Research Associates of Maryland
🇺🇸Lanham, Maryland, United States
Midwest Pharmaceutical Research
🇺🇸St. Peters, Missouri, United States
Grand Rapids Associated Interns
🇺🇸Grand Rapids, Michigan, United States
Mid Missouri Research Specialists, Inc.
🇺🇸Rolla, Missouri, United States
Radiant Research-St. Louis
🇺🇸St. Louis, Missouri, United States
HIS Clinical Research
🇺🇸Jersey City, New Jersey, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
Radiant Research-Moorestown
🇺🇸Moorestown, New Jersey, United States
New Jersey Physicians
🇺🇸Passaic, New Jersey, United States
St. Lukes Roosevelt Hospital
🇺🇸New York, New York, United States
Medical Network Services, P.C.
🇺🇸Brooklyn, New York, United States
Naomi Berrie Diabetes Center at Columbia University
🇺🇸New York, New York, United States
Heights Medical Care
🇺🇸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
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Charlotte Clinical Research
🇺🇸Charlotte, North Carolina, United States
New Hanover Medical Research Associates
🇺🇸Wilmington, North Carolina, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Unifour Medical Research
🇺🇸Hickory, North Carolina, United States
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
University Mednet
🇺🇸Mentor, Ohio, United States
COR Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Medford Medical Clinic
🇺🇸Medford, Oregon, United States
Utica Park Clinic
🇺🇸Tulsa, Oklahoma, United States
Physicians for Clinical Research
🇺🇸Camp Hill, Pennsylvania, United States
Tipton Medical and Diagnostic Center
🇺🇸Tipton, Pennsylvania, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Radiant Research-Charleston
🇺🇸Charleston, South Carolina, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
CNS Clinical Trials
🇺🇸Chester, South Carolina, United States
Harmony Clinical Research
🇺🇸Johnson City, Tennessee, United States
Rafael Canadas M.D., P.A.
🇺🇸Dallas, Texas, United States
Integrity Clinical Research
🇺🇸Jackson, Tennessee, United States
Internal Medicine Associates
🇺🇸El Paso, Texas, United States
North Texas Clinical Research
🇺🇸Irving, Texas, United States
Dr. Humberto Bruschetta
🇺🇸Kingsville, Texas, United States
South Texas Applied Research
🇺🇸McAllen, Texas, United States
West Olympia Internal Medicine
🇺🇸Olympia, Washington, United States
Evergreen Diabetes & Endocrinology
🇺🇸Kirkland, Washington, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Northside Internal Medicine
🇺🇸Spokane, Washington, United States
Rockwood Clinic
🇺🇸Spokane, Washington, United States
Hyperion Clinical Research
🇺🇸Charleston, West Virginia, United States
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
Physicians Group Research Clinic, LLC
🇺🇸Little Rock, Arkansas, United States
Arrowhead Regional Medical Center
🇺🇸Colton, California, United States
Radiant Research
🇺🇸Portland, Oregon, United States