Extension Study for 2993-112
An Open-Label Extension Study of Protocol 2993-112 to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of AC2993 Given Two Times a Day to Subjects Treated With Metformin Alone
1 other identifier
interventional
225
2 countries
226
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes-mellitus
Started Sep 2002
226 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 11, 2013
CompletedFirst Posted
Study publicly available on registry
February 12, 2013
CompletedFebruary 24, 2015
January 1, 2015
1.8 years
February 11, 2013
February 23, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination)
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.
Day 1 of study 2993-112 through extension study termination (up to Week 52)
Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination)
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.
Day 1 of study 2993-112 through extension study termination (up to Week 52)
Study Arms (1)
Open-label AC2993
EXPERIMENTALInterventions
4-Week transition of AC2993 5 mcg subcutaneously injected twice daily followed by an open-ended period through study termination (up to 52 weeks) of AC2993 10 mcg subcutaneously injected twice daily
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (226)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Parkway Medical Center
Birmingham, Alabama, 35206, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
Eclectic Family Care
Eclectic, Alabama, 36024, United States
Winston Physician Services
Haleyville, Alabama, 35565, United States
Simon Williamson Clinic
Hueytown, Alabama, 35023, United States
Extended Arm Physicians/ Southern Drug
Montgomery, Alabama, 36106, United States
Southern Drug Research Network
Tallassee, Alabama, 36078, United States
Mesa Center for Clinical Research
Chandler, Arizona, 85224, United States
Clinic of Physicians and Surgeons, Ltd.
Mesa, Arizona, 85201, United States
ANA Ventures, LLC
Mesa, Arizona, 85204, United States
Lovelace Scientific Resources
Phoenix, Arizona, 85016, United States
Physicians at the Peak
Phoenix, Arizona, 85020, United States
Advanced Clinical Therapeutics
Tucson, Arizona, 85712, United States
First Care Family Doctors
Fayetteville, Arkansas, 72701, United States
CAVHS
Little Rock, Arkansas, 72205, United States
Physicians Group Research Clinic, LLC
Little Rock, Arkansas, 72205, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Endocrine Metabolic Medical Center
Atherton, California, 94027, United States
Mitchell Research Group, Inc.
Bakersfield, California, 93309, United States
William Zigrang, M.D.
Burlingame, California, 94010, United States
International Clinical Research Network
Chula Vista, California, 91910, United States
Arrowhead Regional Medical Center
Colton, California, 92324, United States
East Bay Clinical Trial Center
Concord, California, 94520, United States
Medical Group of Encino
Encino, California, 91436, United States
Mowry Clinical Research
Fremont, California, 94538, United States
SARC Research Center
Fresno, California, 93720-2955, United States
Valley Research
Fresno, California, 93720, United States
Irvine Clinical Research Center
Irvine, California, 92618, United States
Whittier Institute for Diabetes
La Jolla, California, 92037, United States
Harriman Jones Medical Group
Long Beach, California, 90806, United States
Richard Cherlin, M.D.
Los Gatos, California, 95032, United States
Tushar Modi, M.D.
Modesto, California, 95350, United States
Dr. Martinez Medical Clinic
Moreno Valley, California, 92553, United States
Arroyo Seco Medical Group
Pasadena, California, 91105, United States
Elke Jost-Vu, M.D.
Rancho Mirage, California, 92270, United States
Comprehensive Diabetes-Endocrine Medical Associates
Redwood City, California, 94062, United States
nTouch
San Diego, California, 92103, United States
Radiant Research
San Diego, California, 92108, United States
San Diego Endocrine and Medical Clinic
San Diego, California, 92108, United States
Veterans Medical Research Foundation
San Diego, California, 92161, United States
Diabetes Research Institute of Mills Peninsula
San Mateo, California, 94401, United States
Advanced Clinical Research Institute
Santa Ana, California, 92701, United States
Pacific Clinical Research
Santa Monica, California, 90404, United States
West Coast Clinical Trials
Signal Hill, California, 90755, United States
Protocare Trials at Sharp Mission Park
Vista, California, 92083, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
University of Colorado-Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80262, United States
Pheonix International Medicine Associates
Waterbury, Connecticut, 06708, United States
Health Core at Health Care Center Christiana
Newark, Delaware, 19713, United States
Medstar Clinical Research
Washington D.C., District of Columbia, 20003-4393, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Morton Plant Mease Health Care
Clearwater, Florida, 33756, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Atlantic Institute of Clinical Research
Daytona Beach, Florida, 32114, United States
Halifax Clinical Research Institute
Daytona Beach, Florida, 32114, United States
Internal Medical Associates
Fort Myers, Florida, 33901, United States
Clin Sci International
Gainesville, Florida, 32605, United States
University of FL
Gainesville, Florida, 32610-0226, United States
South Florida Clinical Research Center
Hollywood, Florida, 33023, United States
Health Trials 3000
Jacksonville, Florida, 32250, United States
Jupiter Research Institute
Jupiter, Florida, 33458, United States
ICSL Clinical Studies
Maitland, Florida, 32751, United States
Baptist Diabetes Associates
Miami, Florida, 33176, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
VRG Research
Orlando, Florida, 32801, United States
Highland Lakes Medical Center
Palm Harbor, Florida, 34684, United States
Tallahassee Endocrine Associates
Tallahassee, Florida, 32308, United States
Biostator / USF Diabetes Center
Tampa, Florida, 33612, United States
Tampa Medical Group
Tampa, Florida, 33614, United States
Diabetes and Endocrine Associates of the Treasure Co
Vero Beach, Florida, 32967, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Radiant Research
West Palm Beach, Florida, 33407, United States
ICSL-Clinical Studies
Atlanta, Georgia, 30328, United States
Clinical Research Atlanta
Atlanta, Georgia, 30342, United States
Columbus Metabolic Foundation
Columbus, Georgia, 31901, United States
nTouch Research Corporation
Decatur, Georgia, 30033, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96813, United States
Radiant Research
Honolulu, Hawaii, 96814, United States
St. Luke's Family Health
Meridian, Idaho, 83642, United States
University Primary Care Center at Belvidere
Belvidere, Illinois, 61008, United States
Northwestern Memorail Physicians Group
Chicago, Illinois, 60602, United States
Illinois Center for Clinical Trials
Chicago, Illinois, 60610, United States
Cook County Hospital
Chicago, Illinois, 60612, United States
Lake Forest Internal Medicine
Libertyville, Illinois, 60048, United States
Winchester Research Group
Libertyville, Illinois, 60048, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Springfield Diabetes and Endocrinology
Springfield, Illinois, 62704, United States
Medical Group of Fort Wayne
Fort Wayne, Indiana, 46804, United States
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, 46202, United States
American Health Network
Indianapolis, Indiana, 46222, United States
Center for Metabolic and Hormonal Disorders
Indianapolis, Indiana, 46260, United States
nTouch Research Corporation
South Bend, Indiana, 46601, United States
Ramona Holiday Diabetes Center
Des Moines, Iowa, 50314, United States
Diabetes Clinical Research and Programs
Iowa City, Iowa, 52242-1009, United States
Lipid, Atherosclerosis & Metabolic Clinic
Kansas City, Kansas, 66160, United States
Kentucky Diabetes Center
Lexington, Kentucky, 40503, United States
Central Kentucky Research Associates
Lexington, Kentucky, 40509, United States
University of Kentucky Metabolic Research Group
Lexington, Kentucky, 40536-9841, United States
MedResearch, Inc.
Louisville, Kentucky, 40223, United States
Drug Research Services
Metairie, Louisiana, 70001, United States
New Orleans Institute of Clinical Investigation
New Orleans, Louisiana, 70112, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Diabetes, Endocrine and Nutrition Center
Bangor, Maine, 04401, United States
VA Medical Center
Baltimore, Maryland, 21201, United States
St. Agnes Health Care
Baltimore, Maryland, 21229, United States
Doctors Research Associates of Maryland
Lanham, Maryland, 20706, United States
University of Michigan-Endocrinology and Metabolism
Ann Arbor, Michigan, 48109, United States
Grunberger Diabetes Medical Center
Bloomfield Hills, Michigan, 48302, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Grand Rapids Associated Interns
Grand Rapids, Michigan, 49506, United States
Westside Family Medical Center
Kalamazoo, Michigan, 49009, United States
Mayo Clinic, Division of Endocrinology and Metabolism
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Diabetes and Endocrinology Specialists
Chesterfield, Missouri, 63017, United States
Midwest Pharmaceutical Research
City of Saint Peters, Missouri, 63376, United States
Medical Arts Research Collaborative
Excelsior Springs, Missouri, 64024, United States
St Lukes Lipid and Diabetes Research Center
Kansas City, Missouri, 64111, United States
Mid Missouri Research Specialists, Inc.
Rolla, Missouri, 65401, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Radiant Research
St Louis, Missouri, 63141, United States
Mercury Street Medical
Butte, Montana, 59701, United States
Creighton Diabetes Center
Omaha, Nebraska, 68131, United States
Lovelace Scientific Resources
Las Vegas, Nevada, 89102, United States
ICSL
Las Vegas, Nevada, 89106, United States
Endocrinology and Diabetes Consultants, P.C.
Dover, New Hampshire, 03820, United States
HIS Clinical Research
Jersey City, New Jersey, 07306, United States
Radiant Research
Moorestown, New Jersey, 08057, United States
Matrix Research Institute
Mount Laurel, New Jersey, 08054, United States
New Jersey Physicians
Passaic, New Jersey, 07055, United States
Anderson and Collins Clinical Research, Inc.
South Plainfield, New Jersey, 07080, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108, United States
SUNY Downstate
Brooklyn, New York, 11203, United States
Medical Network Services, P.C.
Brooklyn, New York, 11230, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
St. Lukes Roosevelt Hospital
New York, New York, 10025, United States
Irving Diabetes Research Unit at Columbia University
New York, New York, 10032, United States
Naomi Berrie Diabetes Center at Columbia University
New York, New York, 10032, United States
Heights Medical Care
New York, New York, 10033, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Albert Einstein College of Medicine of Yeshiva University
The Bronx, New York, 10467, United States
DOCS at Beth Israel Medical Center
Yonkers, New York, 10710, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Charlotte Clinical Research
Charlotte, North Carolina, 28211, United States
UNC Diabetes Care Center
Durham, North Carolina, 27713, United States
Unifour Medical Research
Hickory, North Carolina, 28601, United States
New Hanover Medical Research Associates
Wilmington, North Carolina, 28412, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
Rapid Medical Research
Cleveland, Ohio, 44124, United States
Ohio State University-Division of Endocrinology
Columbus, Ohio, 43210, United States
Radiant Research
Columbus, Ohio, 43212, United States
University Mednet
Mentor, Ohio, 44060, United States
Comprehensive Research Services, Inc.
Mogadore, Ohio, 44260, United States
North Coast Institute of Diabetes and Endocrinology
Westlake, Ohio, 44145, United States
Prime Care Clinical Research
Clinton, Oklahoma, 73601, United States
COR Clinical Research
Oklahoma City, Oklahoma, 73103, United States
OU Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
nTouch Research Corporation
Oklahoma City, Oklahoma, 73112, United States
Utica Park Clinic
Tulsa, Oklahoma, 74104, United States
Americas Doctors
Medford, Oregon, 97504, United States
Medford Medical Clinic
Medford, Oregon, 97504, United States
Radiant Research
Portland, Oregon, 97201, United States
Portland Diabetes and Endocrinology Center
Portland, Oregon, 97210, United States
Pacific Coast Clinical Coordinators, Inc.
Portland, Oregon, 97214, United States
Legacy Clinical Research
Portland, Oregon, 97232, United States
Physicians for Clinical Research
Camp Hill, Pennsylvania, 17011, United States
Argus Research Laboratories
Horsham, Pennsylvania, 19044-12297, United States
Thomas Jefferson University Diabetes Research Center
Philadelphia, Pennsylvania, 19107, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Philadelphia Health Associates
Philadelphia, Pennsylvania, 19146, United States
Elite Medical Research, Inc.
Sellersville, Pennsylvania, 18960, United States
Tipton Medical and Diagnostic Center
Tipton, Pennsylvania, 16684, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914, United States
ICSL-Providence
East Providence, Rhode Island, 02915, United States
Radiant Research
Charleston, South Carolina, 29407, United States
CNS Clinical Trials
Chester, South Carolina, 29706, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Tennessee Valley Clinical Research Associates
Alcoa, Tennessee, 37701, United States
Integrity Clinical Research
Jackson, Tennessee, 38305, United States
Harmony Clinical Research
Johnson City, Tennessee, 37601, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Endocrine Consultants of ET
Knoxville, Tennessee, 37909, United States
The Endocrine Clinic
Memphis, Tennessee, 38119, United States
Integrity Clinical Research
Milan, Tennessee, 38358, United States
Mid State Endocrine Associates
Nashville, Tennessee, 37203, United States
Israel A. Hartman, M.D.
Arlington, Texas, 76014, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Dallas Diabetes and Endocrinology Research Center
Dallas, Texas, 75230, United States
Rafael Canadas M.D., P.A.
Dallas, Texas, 75251, United States
Texas Tech University Health Sciences-Internal Medicine
El Paso, Texas, 79905, United States
Internal Medicine Associates
El Paso, Texas, 79912, United States
Lanier Education Research Network
Fort Worth, Texas, 76107, United States
North Texas Clinical Research
Irving, Texas, 75038, United States
Dr. Humberto Bruschetta
Kingsville, Texas, 78363, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
South Texas Applied Research
McAllen, Texas, 78503, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
University of Texas Health Sciences Center-Texas Diabetes Institute
San Antonio, Texas, 78207, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229-3894, United States
SAM Clinical Research
San Antonio, Texas, 78229, United States
Utah Diabetes Center at the University of Utah
Salt Lake City, Utah, 84108, United States
Salt Lake Research
Salt Lake City, Utah, 84124, United States
Medical Associates of Northern Virginia
Arlington, Virginia, 22204, United States
Clinical Research Center-Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Drs. Wigand, Wasserman, and Associates
Richmond, Virginia, 23225, United States
Evergreen Diabetes & Endocrinology
Kirkland, Washington, 98034, United States
Olympic Medical Services
Lacey, Washington, 98516, United States
West Olympia Internal Medicine
Olympia, Washington, 98502, United States
Rainier Clinical Research Center
Renton, Washington, 98055, United States
Northside Internal Medicine
Spokane, Washington, 99201, United States
Rockwood Clinic
Spokane, Washington, 99202, United States
Julia M. Hutchinson, M.D.
Spokane, Washington, 99204, United States
Wenatchee Valley Clinic
Wenatchee, Washington, 98801, United States
Hyperion Clinical Research
Charleston, West Virginia, 25301, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
University of Wisconsin West Clinic
Madison, Wisconsin, 53711, United States
Midwest Endocrinology Associates
Milwaukee, Wisconsin, 53215, United States
VRG Research
Milwaukee, Wisconsin, 53226, United States
Calgary Metabolic Education and Research Center
Calgary, Alberta, T3B 0M3, Canada
Walter McKenzie Health Sciences Centre
Edmonton, Alberta, T6G 2B7, Canada
St. Paul's Hospital, Research Services
Vancouver, British Columbia, V6Z 1Y6, Canada
Health Sciences Center
Winnipeg, Manitoba, R3A 1R9, Canada
University of Western Ontario
London, Ontario, N6A 4V2, Canada
McGill Nutrition and Food Science Center
Montreal, Quebec, H3A 1A1, Canada
Centre Hospitalier
Ste. Foy, Quebec, G1V 4G2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2013
First Posted
February 12, 2013
Study Start
September 1, 2002
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
February 24, 2015
Record last verified: 2015-01