Extension Study for 2993-112
- Registration Number
- NCT01789957
- Lead Sponsor
- AstraZeneca
- Brief Summary
This multicenter, open-label extension study of Protocol 2993-112 is designed to assess long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate long-term safety and tolerability in subjects treated with metformin who receive subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing Protocol 2993-112 are eligible to enroll.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-label AC2993 AC2993 -
- Primary Outcome Measures
Name Time Method Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination) Day 1 of study 2993-112 through extension study termination (up to Week 52) Change in HbA1c from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination) Day 1 of study 2993-112 through extension study termination (up to Week 52) Change in body weight (KG) from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (212)
Diabetes, Endocrine and Nutrition Center
🇺🇸Bangor, Maine, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
St. Agnes Health Care
🇺🇸Baltimore, Maryland, United States
Baptist Diabetes Associates
🇺🇸Miami, Florida, United States
American Health Network
🇺🇸Indianapolis, Indiana, United States
Center for Metabolic and Hormonal Disorders
🇺🇸Indianapolis, Indiana, United States
Physicians at the Peak
🇺🇸Phoenix, Arizona, United States
nTouch
🇺🇸San Diego, California, United States
nTouch Research Corporation
🇺🇸Oklahoma City, Oklahoma, United States
COR Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Mid State Endocrine Associates
🇺🇸Nashville, Tennessee, 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
Diabetes and Glandular Disease Clinic
🇺🇸San Antonio, Texas, United States
Utah Diabetes Center at the University of Utah
🇺🇸Salt Lake City, Utah, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Parkway Medical Center
🇺🇸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
Endocrine Metabolic Medical Center
🇺🇸Atherton, California, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
Mesa Center for Clinical Research
🇺🇸Chandler, Arizona, United States
Simon Williamson Clinic
🇺🇸Hueytown, Alabama, United States
Advanced Clinical Research Institute
🇺🇸Santa Ana, California, United States
East Bay Clinical Trial Center
🇺🇸Concord, California, United States
Irvine Clinical Research Center
🇺🇸Irvine, California, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Physicians Group Research Clinic, LLC
🇺🇸Little Rock, Arkansas, United States
International Clinical Research Network
🇺🇸Chula Vista, California, United States
SARC Research Center
🇺🇸Fresno, California, United States
Valley Research
🇺🇸Fresno, California, United States
Arrowhead Regional Medical Center
🇺🇸Colton, California, United States
Comprehensive Diabetes-Endocrine Medical Associates
🇺🇸Redwood City, California, United States
Mowry Clinical Research
🇺🇸Fremont, California, United States
Pheonix International Medicine Associates
🇺🇸Waterbury, Connecticut, United States
Harriman Jones Medical Group
🇺🇸Long Beach, California, United States
Medical Group of Encino
🇺🇸Encino, California, United States
Morton Plant Mease Health Care
🇺🇸Clearwater, Florida, United States
West Coast Clinical Trials
🇺🇸Signal Hill, California, United States
Diabetes Research Institute of Mills Peninsula
🇺🇸San Mateo, California, United States
Health Core at Health Care Center Christiana
🇺🇸Newark, Delaware, United States
Pacific Clinical Research
🇺🇸Santa Monica, California, United States
Medstar Clinical Research
🇺🇸Washington, District of Columbia, United States
Atlantic Institute of Clinical Research
🇺🇸Daytona Beach, Florida, United States
Winchester Research Group
🇺🇸Libertyville, Illinois, United States
Health Trials 3000
🇺🇸Jacksonville, Florida, United States
Jupiter Research Institute
🇺🇸Jupiter, Florida, United States
Lake Forest Internal Medicine
🇺🇸Libertyville, Illinois, United States
Ramona Holiday Diabetes Center
🇺🇸Des Moines, Iowa, United States
Lipid, Atherosclerosis & Metabolic Clinic
🇺🇸Kansas City, Kansas, United States
ICSL-Clinical Studies
🇺🇸Atlanta, Georgia, United States
Diabetes and Endocrine Associates of the Treasure Co
🇺🇸Vero Beach, Florida, United States
Northwestern Memorail Physicians Group
🇺🇸Chicago, Illinois, United States
Illinois Center for Clinical Trials
🇺🇸Chicago, Illinois, United States
Indiana University Outpatient Clinical Research
🇺🇸Indianapolis, Indiana, United States
Kentucky Diabetes Center
🇺🇸Lexington, Kentucky, United States
University of Kentucky Metabolic Research Group
🇺🇸Lexington, Kentucky, United States
Diabetes Clinical Research and Programs
🇺🇸Iowa City, Iowa, United States
St. Luke's Family Health
🇺🇸Meridian, Idaho, United States
VA Medical Center
🇺🇸Baltimore, Maryland, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Columbus Metabolic Foundation
🇺🇸Columbus, Georgia, United States
Doctors Research Associates of Maryland
🇺🇸Lanham, Maryland, United States
University Primary Care Center at Belvidere
🇺🇸Belvidere, Illinois, United States
Central Kentucky Research Associates
🇺🇸Lexington, Kentucky, United States
Drug Research Services
🇺🇸Metairie, Louisiana, United States
Medical Group of Fort Wayne
🇺🇸Fort Wayne, Indiana, United States
Clinical Research Atlanta
🇺🇸Atlanta, Georgia, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Anderson and Collins Clinical Research, Inc.
🇺🇸South Plainfield, New Jersey, United States
ICSL
🇺🇸Las Vegas, Nevada, United States
OU Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Utica Park Clinic
🇺🇸Tulsa, Oklahoma, United States
Midwest Pharmaceutical Research
🇺🇸St. Peters, Missouri, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Medical Network Services, P.C.
🇺🇸Brooklyn, New York, United States
Grand Rapids Associated Interns
🇺🇸Grand Rapids, Michigan, United States
Heights Medical Care
🇺🇸New York, New York, United States
New Hanover Medical Research Associates
🇺🇸Wilmington, North Carolina, United States
Unifour Medical Research
🇺🇸Hickory, North Carolina, United States
Medical Arts Research Collaborative
🇺🇸Excelsior Springs, Missouri, United States
Endocrinology and Diabetes Consultants, P.C.
🇺🇸Dover, New Hampshire, United States
Westside Family Medical Center
🇺🇸Kalamazoo, Michigan, United States
Mid Missouri Research Specialists, Inc.
🇺🇸Rolla, Missouri, United States
New Jersey Physicians
🇺🇸Passaic, New Jersey, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
St. Lukes Roosevelt Hospital
🇺🇸New York, New York, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Matrix Research Institute
🇺🇸Mt. Laurel, New Jersey, United States
Diabetes and Endocrinology Specialists
🇺🇸Chesterfield, Missouri, United States
SUNY Downstate
🇺🇸Brooklyn, New York, United States
Mercury Street Medical
🇺🇸Butte, Montana, United States
HIS Clinical Research
🇺🇸Jersey City, New Jersey, United States
UNC Diabetes Care Center
🇺🇸Durham, North Carolina, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
DOCS at Beth Israel Medical Center
🇺🇸Yonkers, New York, United States
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
Medford Medical Clinic
🇺🇸Medford, Oregon, United States
Argus Research Laboratories
🇺🇸Horsham, Pennsylvania, United States
Thomas Jefferson University Diabetes Research Center
🇺🇸Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Philadelphia Health Associates
🇺🇸Philadelphia, Pennsylvania, United States
Tipton Medical and Diagnostic Center
🇺🇸Tipton, Pennsylvania, United States
ICSL-Providence
🇺🇸East Providence, Rhode Island, United States
CNS Clinical Trials
🇺🇸Chester, South Carolina, United States
Hyperion Clinical Research
🇺🇸Charleston, West Virginia, United States
McGill Nutrition and Food Science Center
🇨🇦Montreal, Quebec, Canada
Harmony Clinical Research
🇺🇸Johnson City, Tennessee, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
South Texas Applied Research
🇺🇸McAllen, Texas, United States
Clinical Research Center-Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Northside Internal Medicine
🇺🇸Spokane, Washington, United States
Julia M. Hutchinson, M.D.
🇺🇸Spokane, Washington, United States
West Olympia Internal Medicine
🇺🇸Olympia, Washington, United States
Lanier Education Research Network
🇺🇸Fort Worth, Texas, United States
Israel A. Hartman, M.D.
🇺🇸Arlington, Texas, United States
The Endocrine Clinic
🇺🇸Memphis, Tennessee, United States
Internal Medicine Associates
🇺🇸El Paso, Texas, United States
Wenatchee Valley Clinic
🇺🇸Wenatchee, Washington, United States
St. Paul's Hospital, Research Services
🇨🇦Vancouver, British Columbia, Canada
University of Colorado-Barbara Davis Center for Childhood Diabetes
🇺🇸Denver, Colorado, United States
Portland Diabetes and Endocrinology Center
🇺🇸Portland, Oregon, United States
Pacific Coast Clinical Coordinators, Inc.
🇺🇸Portland, Oregon, United States
Legacy Clinical Research
🇺🇸Portland, Oregon, United States
Centre Hospitalier
🇨🇦Ste. Foy, Quebec, Canada
Calgary Metabolic Education and Research Center
🇨🇦Calgary, Alberta, Canada
Health Sciences Center
🇨🇦Winnipeg, Manitoba, Canada
Mayo Clinic, Division of Endocrinology and Metabolism
🇺🇸Rochester, Minnesota, United States
VRG Research
🇺🇸Milwaukee, Wisconsin, United States
Creighton Diabetes Center
🇺🇸Omaha, Nebraska, United States
Midwest Endocrinology Associates
🇺🇸Milwaukee, Wisconsin, United States
Southern Drug Research Network
🇺🇸Tallassee, Alabama, United States
Prime Care Clinical Research
🇺🇸Clinton, Oklahoma, United States
Integrity Clinical Research
🇺🇸Milan, Tennessee, United States
University Mednet
🇺🇸Mentor, Ohio, United States
Whittier Institute for Diabetes
🇺🇸La Jolla, California, United States
Richard Cherlin, M.D.
🇺🇸Los Gatos, California, United States
ANA Ventures, LLC
🇺🇸Mesa, Arizona, United States
Halifax Clinical Research Institute
🇺🇸Daytona Beach, Florida, United States
Internal Medical Associates
🇺🇸Ft. Myers, Florida, United States
South Florida Clinical Research Center
🇺🇸Hollywood, Florida, United States
ICSL Clinical Studies
🇺🇸Maitland, Florida, United States
Highland Lakes Medical Center
🇺🇸Palm Harbor, Florida, United States
Elite Medical Research, Inc.
🇺🇸Sellersville, Pennsylvania, United States
Rafael Canadas M.D., P.A.
🇺🇸Dallas, Texas, United States
Cook County Hospital
🇺🇸Chicago, Illinois, United States
Protocare Trials at Sharp Mission Park
🇺🇸Vista, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Veterans Medical Research Foundation
🇺🇸San Diego, California, United States
San Diego Endocrine and Medical Clinic
🇺🇸San Diego, California, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
St. Louis Center for Clinical Research
🇺🇸St. Louis, Missouri, United States
Tallahassee Endocrine Associates
🇺🇸Tallahassee, Florida, United States
Ohio State University-Division of Endocrinology
🇺🇸Columbus, Ohio, United States
Charlotte Clinical Research
🇺🇸Charlotte, North Carolina, United States
Springfield Diabetes and Endocrinology
🇺🇸Springfield, Illinois, United States
North Coast Institute of Diabetes and Endocrinology
🇺🇸Westlake, Ohio, United States
Eclectic Family Care
🇺🇸Eclectic, Alabama, United States
CAVHS
🇺🇸Little Rock, Arkansas, United States
First Care Family Doctors
🇺🇸Fayetteville, Arkansas, United States
Mitchell Research Group, Inc.
🇺🇸Bakersfield, California, United States
Tushar Modi, M.D.
🇺🇸Modesto, California, United States
Dr. Martinez Medical Clinic
🇺🇸Moreno Valley, California, United States
Elke Jost-Vu, M.D.
🇺🇸Rancho Mirage, California, United States
Arroyo Seco Medical Group
🇺🇸Pasadena, California, United States
Grunberger Diabetes Medical Center
🇺🇸Bloomfield Hills, Michigan, United States
Naomi Berrie Diabetes Center at Columbia University
🇺🇸New York, New York, United States
Irving Diabetes Research Unit at Columbia University
🇺🇸New York, New York, United States
Comprehensive Research Services, Inc.
🇺🇸Mogadore, Ohio, United States
Americas Doctors
🇺🇸Medford, Oregon, United States
Physicians for Clinical Research
🇺🇸Camp Hill, Pennsylvania, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
Endocrine Consultants of ET
🇺🇸Knoxville, Tennessee, United States
Dallas Diabetes and Endocrinology Research Center
🇺🇸Dallas, Texas, United States
Texas Tech University Health Sciences-Internal Medicine
🇺🇸El Paso, Texas, United States
Dr. Humberto Bruschetta
🇺🇸Kingsville, Texas, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Medical Associates of Northern Virginia
🇺🇸Arlington, Virginia, United States
Olympic Medical Services
🇺🇸Lacey, Washington, United States
University of Wisconsin West Clinic
🇺🇸Madison, Wisconsin, United States
Walter McKenzie Health Sciences Centre
🇨🇦Edmonton, Alberta, Canada
University of Western Ontario
🇨🇦London, Ontario, Canada
Clin Sci International
🇺🇸Gainesville, Florida, United States
University of FL
🇺🇸Gainesville, Florida, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Tampa Medical Group
🇺🇸Tampa, Florida, United States
Biostator / USF Diabetes Center
🇺🇸Tampa, Florida, United States
MedResearch, Inc.
🇺🇸Louisville, Kentucky, United States
University of Michigan-Endocrinology and Metabolism
🇺🇸Ann Arbor, Michigan, United States
St Lukes Lipid and Diabetes Research Center
🇺🇸Kansas City, Missouri, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
New Orleans Institute of Clinical Investigation
🇺🇸New Orleans, Louisiana, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
Albert Einstein College of Medicine of Yeshiva University
🇺🇸Bronx, New York, United States
Drs. Wigand, Wasserman, and Associates
🇺🇸Richmond, Virginia, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
William Zigrang, M.D.
🇺🇸Burlingame, California, United States
Tennessee Valley Clinical Research Associates
🇺🇸Alcoa, Tennessee, United States
Evergreen Diabetes & Endocrinology
🇺🇸Kirkland, Washington, United States
North Texas Clinical Research
🇺🇸Irving, Texas, United States
Rockwood Clinic
🇺🇸Spokane, Washington, United States
Radiant Research
🇺🇸Charleston, South Carolina, United States