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Extension Study for 2993-112

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01789957
First received: February 11, 2013
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: AC2993
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination) [ Time Frame: Day 1 of study 2993-112 through extension study termination (up to Week 52) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day 1 of study 2993-112 through extension study termination (up to Week 52) ] [ Designated as safety issue: No ]
    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.


Enrollment: 225
Study Start Date: September 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label AC2993 Drug: AC2993
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
Other Name: Exenatide

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception:

  • Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study termination visit (Week 30).
  • Male or female. Female individuals must be either 1) postmenopausal as documented by serum FSH measurement unless using estrogen for hormone replacement therapy; or 2) of childbearing potential and used appropriate contraceptive methods (surgical sterility or oral, injected, barrier, intrauterine, or implanted contraceptives) for the duration of Protocol 2993-112. This individual must have a current, negative pregnancy test (human chorionic gonadotropin [HCG], beta subunit) regardless of birth control method used. The individual agrees to continue using birth control throughout the study to prevent pregnancy.
  • Able to understand and sign a Protocol 2993-112E-specific informed consent form, communicate with the investigator, and understand and comply with the protocol requirements.

Individuals meeting any of the following criteria are to be excluded from the study unless the sponsor grants an exception:

  • Has not completed Protocol 2993-112.
  • Female individuals who are pregnant, lactating, or planning to become pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789957

  Hide Study Locations
Locations
United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Parkway Medical Center
Birmingham, Alabama, United States, 35206
Eclectic Family Care
Eclectic, Alabama, United States, 36024
Winston Physician Services
Haleyville, Alabama, United States, 35565
Simon Williamson Clinic
Hueytown, Alabama, United States, 35023
Extended Arm Physicians/ Southern Drug
Montgomery, Alabama, United States, 36106
Southern Drug Research Network
Tallassee, Alabama, United States, 36078
United States, Arizona
Mesa Center for Clinical Research
Chandler, Arizona, United States, 85224
Clinic of Physicians and Surgeons, Ltd.
Mesa, Arizona, United States, 85201
ANA Ventures, LLC
Mesa, Arizona, United States, 85204
Lovelace Scientific Resources
Phoenix, Arizona, United States, 85016
Physicians at the Peak
Phoenix, Arizona, United States, 85020
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
United States, Arkansas
First Care Family Doctors
Fayetteville, Arkansas, United States, 72701
Physicians Group Research Clinic, LLC
Little Rock, Arkansas, United States, 72205
CAVHS
Little Rock, Arkansas, United States, 72205
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Endocrine Metabolic Medical Center
Atherton, California, United States, 94027
Mitchell Research Group, Inc.
Bakersfield, California, United States, 93309
William Zigrang, M.D.
Burlingame, California, United States, 94010
International Clinical Research Network
Chula Vista, California, United States, 91910
Arrowhead Regional Medical Center
Colton, California, United States, 92324
East Bay Clinical Trial Center
Concord, California, United States, 94520
Medical Group of Encino
Encino, California, United States, 91436
Mowry Clinical Research
Fremont, California, United States, 94538
SARC Research Center
Fresno, California, United States, 93720-2955
Valley Research
Fresno, California, United States, 93720
Irvine Clinical Research Center
Irvine, California, United States, 92618
Whittier Institute for Diabetes
La Jolla, California, United States, 92037
Harriman Jones Medical Group
Long Beach, California, United States, 90806
Richard Cherlin, M.D.
Los Gatos, California, United States, 95032
Tushar Modi, M.D.
Modesto, California, United States, 95350
Dr. Martinez Medical Clinic
Moreno Valley, California, United States, 92553
Arroyo Seco Medical Group
Pasadena, California, United States, 91105
Elke Jost-Vu, M.D.
Rancho Mirage, California, United States, 92270
Comprehensive Diabetes-Endocrine Medical Associates
Redwood City, California, United States, 94062
nTouch
San Diego, California, United States, 92103
Radiant Research
San Diego, California, United States, 92108
San Diego Endocrine and Medical Clinic
San Diego, California, United States, 92108
Veterans Medical Research Foundation
San Diego, California, United States, 92161
Diabetes Research Institute of Mills Peninsula
San Mateo, California, United States, 94401
Advanced Clinical Research Institute
Santa Ana, California, United States, 92701
Pacific Clinical Research
Santa Monica, California, United States, 90404
West Coast Clinical Trials
Signal Hill, California, United States, 90755
Protocare Trials at Sharp Mission Park
Vista, California, United States, 92083
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado-Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80262
United States, Connecticut
Pheonix International Medicine Associates
Waterbury, Connecticut, United States, 06708
United States, Delaware
Health Core at Health Care Center Christiana
Newark, Delaware, United States, 19713
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
Medstar Clinical Research
Washington, District of Columbia, United States, 20003-4393
United States, Florida
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
Atlantic Institute of Clinical Research
Daytona Beach, Florida, United States, 32114
Halifax Clinical Research Institute
Daytona Beach, Florida, United States, 32114
Internal Medical Associates
Ft. Myers, Florida, United States, 33901
Clin Sci International
Gainesville, Florida, United States, 32605
University of FL
Gainesville, Florida, United States, 32610-0226
South Florida Clinical Research Center
Hollywood, Florida, United States, 33023
Health Trials 3000
Jacksonville, Florida, United States, 32250
Jupiter Research Institute
Jupiter, Florida, United States, 33458
ICSL Clinical Studies
Maitland, Florida, United States, 32751
Baptist Diabetes Associates
Miami, Florida, United States, 33176
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
VRG Research
Orlando, Florida, United States, 32801
Highland Lakes Medical Center
Palm Harbor, Florida, United States, 34684
Tallahassee Endocrine Associates
Tallahassee, Florida, United States, 32308
Biostator / USF Diabetes Center
Tampa, Florida, United States, 33612
Tampa Medical Group
Tampa, Florida, United States, 33614
Diabetes and Endocrine Associates of the Treasure Co
Vero Beach, Florida, United States, 32967
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States, 33401
Radiant Research
West Palm Beach, Florida, United States, 33407
United States, Georgia
ICSL-Clinical Studies
Atlanta, Georgia, United States, 30328
Clinical Research Atlanta
Atlanta, Georgia, United States, 30342
Columbus Metabolic Foundation
Columbus, Georgia, United States, 31901
nTouch Research Corporation
Decatur, Georgia, United States, 30033
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96813
Radiant Research
Honolulu, Hawaii, United States, 96814
United States, Idaho
St. Luke's Family Health
Meridian, Idaho, United States, 83642
United States, Illinois
University Primary Care Center at Belvidere
Belvidere, Illinois, United States, 61008
Cook County Hospital
Chicago, Illinois, United States, 60612
Illinois Center for Clinical Trials
Chicago, Illinois, United States, 60610
Northwestern Memorail Physicians Group
Chicago, Illinois, United States, 60602
Lake Forest Internal Medicine
Libertyville, Illinois, United States, 60048
Winchester Research Group
Libertyville, Illinois, United States, 60048
Springfield Clinic
Springfield, Illinois, United States, 62703
Springfield Diabetes and Endocrinology
Springfield, Illinois, United States, 62704
United States, Indiana
Medical Group of Fort Wayne
Fort Wayne, Indiana, United States, 46804
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, United States, 46202
Center for Metabolic and Hormonal Disorders
Indianapolis, Indiana, United States, 46260
American Health Network
Indianapolis, Indiana, United States, 46222
nTouch Research Corporation
South Bend, Indiana, United States, 46601
United States, Iowa
Ramona Holiday Diabetes Center
Des Moines, Iowa, United States, 50314
Diabetes Clinical Research and Programs
Iowa City, Iowa, United States, 52242-1009
United States, Kansas
Lipid, Atherosclerosis & Metabolic Clinic
Kansas City, Kansas, United States, 66160
United States, Kentucky
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
Kentucky Diabetes Center
Lexington, Kentucky, United States, 40503
University of Kentucky Metabolic Research Group
Lexington, Kentucky, United States, 40536-9841
MedResearch, Inc.
Louisville, Kentucky, United States, 40223
United States, Louisiana
Drug Research Services
Metairie, Louisiana, United States, 70001
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States, 70119
New Orleans Institute of Clinical Investigation
New Orleans, Louisiana, United States, 70112
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maine
Diabetes, Endocrine and Nutrition Center
Bangor, Maine, United States, 04401
United States, Maryland
VA Medical Center
Baltimore, Maryland, United States, 21201
St. Agnes Health Care
Baltimore, Maryland, United States, 21229
Doctors Research Associates of Maryland
Lanham, Maryland, United States, 20706
United States, Michigan
University of Michigan-Endocrinology and Metabolism
Ann Arbor, Michigan, United States, 48109
Grunberger Diabetes Medical Center
Bloomfield Hills, Michigan, United States, 48302
Henry Ford Health System
Detroit, Michigan, United States, 48202
Grand Rapids Associated Interns
Grand Rapids, Michigan, United States, 49506
Westside Family Medical Center
Kalamazoo, Michigan, United States, 49009
United States, Minnesota
Mayo Clinic, Division of Endocrinology and Metabolism
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Diabetes and Endocrinology Specialists
Chesterfield, Missouri, United States, 63017
Medical Arts Research Collaborative
Excelsior Springs, Missouri, United States, 64024
St Lukes Lipid and Diabetes Research Center
Kansas City, Missouri, United States, 64111
Mid Missouri Research Specialists, Inc.
Rolla, Missouri, United States, 65401
Radiant Research
St. Louis, Missouri, United States, 63141
St. Louis Center for Clinical Research
St. Louis, Missouri, United States, 63128
Midwest Pharmaceutical Research
St. Peters, Missouri, United States, 63376
United States, Montana
Mercury Street Medical
Butte, Montana, United States, 59701
United States, Nebraska
Creighton Diabetes Center
Omaha, Nebraska, United States, 68131
United States, Nevada
ICSL
Las Vegas, Nevada, United States, 89106
Lovelace Scientific Resources
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Endocrinology and Diabetes Consultants, P.C.
Dover, New Hampshire, United States, 03820
United States, New Jersey
HIS Clinical Research
Jersey City, New Jersey, United States, 07306
Radiant Research
Moorestown, New Jersey, United States, 08057
Matrix Research Institute
Mt. Laurel, New Jersey, United States, 08054
New Jersey Physicians
Passaic, New Jersey, United States, 07055
Anderson and Collins Clinical Research, Inc.
South Plainfield, New Jersey, United States, 07080
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Albert Einstein College of Medicine of Yeshiva University
Bronx, New York, United States, 10467
Medical Network Services, P.C.
Brooklyn, New York, United States, 11230
SUNY Downstate
Brooklyn, New York, United States, 11203
Winthrop University Hospital
Mineola, New York, United States, 11501
St. Lukes Roosevelt Hospital
New York, New York, United States, 10025
Irving Diabetes Research Unit at Columbia University
New York, New York, United States, 10032
Naomi Berrie Diabetes Center at Columbia University
New York, New York, United States, 10032
Heights Medical Care
New York, New York, United States, 10033
Rochester Clinical Research
Rochester, New York, United States, 14609
DOCS at Beth Israel Medical Center
Yonkers, New York, United States, 10710
United States, North Carolina
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
Charlotte Clinical Research
Charlotte, North Carolina, United States, 28211
UNC Diabetes Care Center
Durham, North Carolina, United States, 27713
Unifour Medical Research
Hickory, North Carolina, United States, 28601
New Hanover Medical Research Associates
Wilmington, North Carolina, United States, 28412
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44124
Ohio State University-Division of Endocrinology
Columbus, Ohio, United States, 43210
Radiant Research
Columbus, Ohio, United States, 43212
University Mednet
Mentor, Ohio, United States, 44060
Comprehensive Research Services, Inc.
Mogadore, Ohio, United States, 44260
North Coast Institute of Diabetes and Endocrinology
Westlake, Ohio, United States, 44145
United States, Oklahoma
Prime Care Clinical Research
Clinton, Oklahoma, United States, 73601
COR Clinical Research
Oklahoma City, Oklahoma, United States, 73103
nTouch Research Corporation
Oklahoma City, Oklahoma, United States, 73112
OU Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Utica Park Clinic
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Americas Doctors
Medford, Oregon, United States, 97504
Medford Medical Clinic
Medford, Oregon, United States, 97504
Legacy Clinical Research
Portland, Oregon, United States, 97232
Pacific Coast Clinical Coordinators, Inc.
Portland, Oregon, United States, 97214
Portland Diabetes and Endocrinology Center
Portland, Oregon, United States, 97210
Radiant Research
Portland, Oregon, United States, 97201
United States, Pennsylvania
Physicians for Clinical Research
Camp Hill, Pennsylvania, United States, 17011
Argus Research Laboratories
Horsham, Pennsylvania, United States, 19044-12297
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Philadelphia Health Associates
Philadelphia, Pennsylvania, United States, 19146
Thomas Jefferson University Diabetes Research Center
Philadelphia, Pennsylvania, United States, 19107
Elite Medical Research, Inc.
Sellersville, Pennsylvania, United States, 18960
Tipton Medical and Diagnostic Center
Tipton, Pennsylvania, United States, 16684
United States, Rhode Island
ICSL-Providence
East Providence, Rhode Island, United States, 02915
Safe Harbor Clinical Research
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Radiant Research
Charleston, South Carolina, United States, 29407
CNS Clinical Trials
Chester, South Carolina, United States, 29706
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Tennessee Valley Clinical Research Associates
Alcoa, Tennessee, United States, 37701
Integrity Clinical Research
Jackson, Tennessee, United States, 38305
Harmony Clinical Research
Johnson City, Tennessee, United States, 37601
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Endocrine Consultants of ET
Knoxville, Tennessee, United States, 37909
The Endocrine Clinic
Memphis, Tennessee, United States, 38119
Integrity Clinical Research
Milan, Tennessee, United States, 38358
Mid State Endocrine Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Israel A. Hartman, M.D.
Arlington, Texas, United States, 76014
Central Texas Clinical Research
Austin, Texas, United States, 78705
Dallas Diabetes and Endocrinology Research Center
Dallas, Texas, United States, 75230
Rafael Canadas M.D., P.A.
Dallas, Texas, United States, 75251
Texas Tech University Health Sciences-Internal Medicine
El Paso, Texas, United States, 79905
Internal Medicine Associates
El Paso, Texas, United States, 79912
Lanier Education Research Network
Fort Worth, Texas, United States, 76107
North Texas Clinical Research
Irving, Texas, United States, 75038
Dr. Humberto Bruschetta
Kingsville, Texas, United States, 78363
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
South Texas Applied Research
McAllen, Texas, United States, 78503
University of Texas Health Sciences Center-Texas Diabetes Institute
San Antonio, Texas, United States, 78207
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78229-3894
Sun Research Institute
San Antonio, Texas, United States, 78205
SAM Clinical Research
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84124
Utah Diabetes Center at the University of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
Medical Associates of Northern Virginia
Arlington, Virginia, United States, 22204
Clinical Research Center-Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Drs. Wigand, Wasserman, and Associates
Richmond, Virginia, United States, 23225
United States, Washington
Evergreen Diabetes & Endocrinology
Kirkland, Washington, United States, 98034
Olympic Medical Services
Lacey, Washington, United States, 98516
West Olympia Internal Medicine
Olympia, Washington, United States, 98502
Rainier Clinical Research Center
Renton, Washington, United States, 98055
Julia M. Hutchinson, M.D.
Spokane, Washington, United States, 99204
Northside Internal Medicine
Spokane, Washington, United States, 99201
Rockwood Clinic
Spokane, Washington, United States, 99202
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801
United States, West Virginia
CAMC Clinical Trials Center
Charleston, West Virginia, United States, 25304
Hyperion Clinical Research
Charleston, West Virginia, United States, 25301
United States, Wisconsin
University of Wisconsin West Clinic
Madison, Wisconsin, United States, 53711
Midwest Endocrinology Associates
Milwaukee, Wisconsin, United States, 53215
VRG Research
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Calgary Metabolic Education and Research Center
Calgary, Alberta, Canada, T3B 0M3
Walter McKenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
St. Paul's Hospital, Research Services
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Health Sciences Center
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 4V2
Canada, Quebec
McGill Nutrition and Food Science Center
Montreal, Quebec, Canada, H3A 1A1
Centre Hospitalier
Ste. Foy, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01789957     History of Changes
Other Study ID Numbers: 2993-112E
Study First Received: February 11, 2013
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014