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Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
This study has been completed.
First Received: May 7, 2002   Last Updated: November 5, 2007   History of Changes
Sponsor: Amylin Pharmaceuticals, Inc.
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00035984
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: AC2993 (synthetic exendin-4)
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
Drug Information available for: Exenatide
U.S. FDA Resources
  Eligibility

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

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035984

  Hide Study Locations
Locations
United States, Alabama
Extended Arm Physicians/ Southern Drug
Montgomery, Alabama, United States, 36106
Parkway Medical Center
Birmingham, Alabama, United States, 35206
Pinnacle Research Group
Anniston, Alabama, United States, 36207
Southern Drug Research Network
Tallassee, Alabama, United States, 36078
United States, Arkansas
First Care Family Doctors
Fayetteville, Arkansas, United States, 72701
Physicians Group Research Clinic, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Medical Group of Encino
Encino, California, United States, 91436
Comprehensive Diabetes-Endocrine Medical Associates
Redwood City, California, United States, 94062
Diablo Clinical Research
Walnut Creek, California, United States
Dr. Martinez Medical Clinic
Moreno Valley, California, United States, 92553
East Bay Clinical Trial Center
Concord, California, United States
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Radiant Research-San Diego
San Diego, California, United States, 92108
Richard Cherlin, M.D.
Los Gatos, California, United States, 95032
Valley Research
Fresno, California, United States, 93720
Veterans Medical Research Foundation
San Diego, California, United States, 92161
Whittier Institute for Diabetes
La Jolla, California, United States, 92037
St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
United States, Colorado
University of Colorado-Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80262
Creekside Endocrine Associates
Denver, Colorado, United States, 80209
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
Baptist Diabetes Associates
Miami, Florida, United States, 33176
Clin Sci International
Gainesville, Florida, United States, 32605
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Internal Medicine Associates
Ft. Myers, Florida, United States
Jupiter Research Institute
Jupiter, Florida, United States, 33458
Medical Research Unlimited
Aventura, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States, 33401
Northeast Florida Endocrine & Diabetes Research
Jacksonville, Florida, United States, 32204
Tallahassee Endocrine Associates
Tallahassee, Florida, United States, 32308
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
Comprehensive NeuroScience Inc.
Sarasota, Florida, United States, 34232
United States, Georgia
Columbus Metabolic Foundation
Columbus, Georgia, United States, 31901
United States, Hawaii
University of Hawaii-Diabetes Research Group
Ewa Beach, Hawaii, United States, 96706
United States, Illinois
Cook County Hospital
Chicago, Illinois, United States, 60612
Illinois Center for Clinical Trials
Chicago, Illinois, United States, 60610
Northwestern Memorial Physicians Group
Chicago, Illinois, United States, 60602
University Primary Care Center at Belvidere
Belvidere, Illinois, United States, 61008
United States, Indiana
American Health Network
Indianapolis, Indiana, United States, 46222
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, United States
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
MedResearch, Inc.
Louisville, Kentucky, United States, 40223
University of Kentucky Metabolic Research Group
Lexington, Kentucky, United States, 40536-9841
United States, Louisiana
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States, 70119
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland-Joslin Diabetes Center
Baltimore, Maryland, United States, 21012
United States, Massachusetts
Clinica Research Inc.
Waltham, Massachusetts, United States, 02154
United States, Michigan
Grand Rapids Associated Interns
Grand Rapids, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Mid Missouri Research Specialists, Inc.
Rolla, Missouri, United States, 65401
Medical Arts Research Collaborative
Excelsior Springs, Missouri, United States, 64024
Diabetes and Endocrinology Specialists
Chesterfield, Missouri, United States, 63017
Midwest Pharmaceutical Research
St. Peters, Missouri, United States, 63376
Radiant Research-St. Louis
St. Louis, Missouri, United States, 63141
St Lukes Lipid and Diabetes Research Center
Kansas City, Missouri, United States, 64111
United States, Montana
Mercury Street Medical
Butte, Montana, United States, 59701
United States, Nevada
Lovelace Scientific Resources-Las Vegas
Las Vegas, Nevada, United States, 89102
Lisa Abbott, MD
Reno, Nevada, United States, 89502
United States, New York
DOCS at Beth Israel Medical Center
Yonkers, New York, United States, 10710
Rochester Clinical Research
Rochester, New York, United States, 14609
St. Lukes Roosevelt Hospital
New York, New York, United States, 10025
SUNY Downstate
Brooklyn, New York, United States, 11203
United States, North Carolina
Charlotte Clinical Research
Charlotte, North Carolina, United States, 28211
New Hanover Medical Research Associates
Wilmington, North Carolina, United States, 28412
UNC Diabetes Care Center
Durham, North Carolina, United States, 27713
Unifour Medical Research
Hickory, North Carolina, United States, 28601
United States, Ohio
Radiant Research-Columbus
Columbus, Ohio, United States, 43212
University Mednet
Mentor, Ohio, United States, 44060
United States, Oklahoma
OU Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Medford Medical Clinic
Medford, Oregon, United States, 97504
Radiant Research
Portland, Oregon, United States
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Philadelphia Health Associates
Philadelphia, Pennsylvania, United States, 19146
Physicians for Clinical Research
Camp Hill, Pennsylvania, United States
Thomas Jefferson University Diabetes Research Center
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
CNS Clinical Trials
Chester, South Carolina, United States, 29706
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Mid State Endocrine Associates
Nashville, Tennessee, United States, 37203
The Endocrine Clinic
Memphis, Tennessee, United States, 38119
United States, Texas
Dallas Diabetes and Endocrinology Research Center
Dallas, Texas, United States, 75230
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78229-3894
Israel A. Hartman, M.D.
Arlington, Texas, United States, 76014
North Texas Clinical Research
Irving, Texas, United States, 75038
SAM Clinical Research
San Antonio, Texas, United States, 78229
Texas Tech University Health Sciences-Internal Medicine
El Paso, Texas, United States, 79905
University of Texas Health Sciences Center-Texas Diabetes Institute
San Antonio, Texas, United States, 78207
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
United States, Washington
Rockwood Clinic
Spokane, Washington, United States, 99202
West Olympia Internal Medicine
Olympia, Washington, United States, 98502
United States, Wisconsin
Midwest Endocrinology Associates
Milwaukee, Wisconsin, United States, 53215
University of Wisconsin West Clinic
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
  More Information

Additional Information:
Link to study results on ClinicalStudyResults.org  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: 2993-115
Study First Received: May 7, 2002
Last Updated: November 5, 2007
ClinicalTrials.gov Identifier: NCT00035984     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2009



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