Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00044694

Purpose

This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.

Condition	Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: AC2993 (synthetic exendin-4)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Estimated Study Completion Date:

May 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with type 2 diabetes
Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
BMI 27-45 kg/m^2
HbA1c between 7.0 % and 8.0 %

Exclusion Criteria:

Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
Patients previously treated with AC2993
Patients presently treated with insulin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044694

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Locations

United States, Alabama
Innovative Clinical Trials
Birmingham, Alabama, United States, 35209
Healthsouth Clinical Research
Birmingham, Alabama, United States, 35243
United States, California
Dr. Martinez Medical Clinic
Moreno Valley, California, United States, 92553
International Clinical Research Network
Chula Vista, California, United States, 91910
Endocrinology Clinic of O.C.
Anaheim, California, United States, 92801
Whittier Institute for Diabetes
La Jolla, California, United States, 92037
Bautista Research and Medical Clinic
Fresno, California, United States, 93721
Richard Cherlin, M.D.
Los Gatos, California, United States, 95032
Pioneer Medical Group
Bellflower, California, United States, 90706
United States, Colorado
Anshutz Outpatient Pavilion
Aurora, Colorado, United States, 80010
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Diagnostic Clinic
Clearwater, Florida, United States, 33760
Radiant Research-Gainsville
Gainsville, Florida, United States, 32605
Radiant Research-Pinellas Park
Pinellas Park, Florida, United States, 33781
United States, Georgia
Clinical Research Group of North Georgia
Blairsville, Georgia, United States, 30512
United States, Hawaii
Radiant Research-Honolulu
Honolulu, Hawaii, United States, 96814
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96813
United States, Idaho
Radiant Research-Boise
Boise, Idaho, United States, 83704
United States, Illinois
Cedar-Crosse Research Center
Chicago, Illinois, United States, 60607
United States, Louisiana
Northshore Medical Research, LLC
Covington, Louisiana, United States, 70433
Medical Research Institute
Slidell, Louisiana, United States, 70458
United States, Massachusetts
Melvin Kramer, MD
Concord, Massachusetts, United States, 01742
United States, Minnesota
Radiant Research-Edina
Edina, Minnesota, United States, 55435
United States, Mississippi
Mississippi Medical Research, LLC
Gulfport, Mississippi, United States, 39501
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Nevada
Innovative Health Research
Las Vegas, Nevada, United States, 89119
United States, North Carolina
Carolina Advanced Research
Cary, North Carolina, United States, 27511
United States, Ohio
Fallen Timbers Internal Medicine, LLC
Maumee, Ohio, United States, 43537
United States, Texas
Diabetes Center of the Southwest
Midland, Texas, United States, 79705
Baylor College of Medicine/Clinical Studies Unit
Houston, Texas, United States, 77030
Healthsouth Clinical Research
Desoto, Texas, United States, 75115
Millenium Research
Benbrook, Texas, United States, 76126
United States, Utah
Utah Diabetes Center at the University of Utah
Salt Lake City, Utah, United States, 84108

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 by Amylin Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26.

Study ID Numbers:	2993-116
Study First Received:	September 3, 2002
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00044694 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:

Diabetes Mellitus, Type 2

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