Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin - Full Text View

Sponsor:	Amylin Pharmaceuticals, Inc.
Collaborator:	Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00099320

Purpose

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide Metformin

U.S. FDA Resources

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

Primary Outcome Measures:

* To test the hypothesis that glycemic control with exenatide is superior to placebo in patients with type 2 diabetes and inadequate glycemic control taking thiazolidinediones alone or thiazolidinediones and metformin.

Secondary Outcome Measures:

* To compare exenatide and placebo groups with respect to various pharmacodynamic measurements and safety and tolerability.

Estimated Enrollment:	280
Study Start Date:	May 2004

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
HbA1c between 7.1% and 10.0%, inclusive.
Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Exclusion Criteria:

Patient previously in a study using exenatide or GLP-1 analogs.
Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
Treated with oral insulin within 3 months of screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099320

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Locations

United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
San Mateo, California, United States
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La Jolla, California, United States
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Santa Barbara, California, United States
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Spring Valley, California, United States
United States, Florida
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Jacksonville, Florida, United States
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Hialeah, Florida, United States
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West Palm Beach, Florida, United States
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Melbourne, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
United States, Hawaii
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Honolulu, Hawaii, United States
United States, Idaho
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Idaho Falls, Idaho, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Louisiana
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Baton Rouge, Louisiana, United States
United States, Michigan
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Troy, Michigan, United States
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Kalamazoo, Michigan, United States
United States, Montana
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Butte, Montana, United States
United States, Nebraska
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Omaha, Nebraska, United States
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McCook, Nebraska, United States
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North Platte, Nebraska, United States
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Scottsbluff, Nebraska, United States
United States, New Jersey
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Princeton, New Jersey, United States
United States, New Mexico
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Albuquerque, New Mexico, United States
United States, New York
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Rochester, New York, United States
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New York, New York, United States
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Albany, New York, United States
United States, North Carolina
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Greenville, North Carolina, United States
United States, Ohio
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Cleveland, Ohio, United States
United States, South Carolina
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Greenville, South Carolina, United States
United States, Tennessee
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
United States, Texas
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Dallas, Texas, United States
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San Antonio, Texas, United States
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The Colony, Texas, United States
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Georgetown, Texas, United States
United States, Washington
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Renton, Washington, United States
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Tacoma, Washington, United States
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Olympia, Washington, United States
United States, West Virginia
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Charleston, West Virginia, United States
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Huntington, West Virginia, United States
Canada, Alberta
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Calgary, Alberta, Canada
Canada, British Columbia
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Vancouver, British Columbia, Canada
Canada, Nova Scotia
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Dartmouth, Nova Scotia, Canada
Canada, Ontario
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Toronto, Ontario, Canada
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London, Ontario, Canada
Canada, Quebec
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Montreal, Quebec, Canada
Spain
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Sevilla, Spain
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Granada, Spain
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Valencia, Spain
Research Site
Valladolid, Spain
Research Site
Zaragoza, Spain

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

James Malone, MD

Eli Lilly and Company

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):

Zinman B, Hoogwerf BJ, Duran Garcia S, Milton DR, Giaconia JM, Kim DD, Trautmann ME, Brodows RG. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Apr 3;146(7):477-85. Erratum in: Ann Intern Med. 2007 Jun 19;146(12):896. Summary for patients in: Ann Intern Med. 2007 Apr 3;146(7):I18.

Study ID Numbers:	H8O-MC-GWAP
Study First Received:	December 10, 2004
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00099320 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Spain: Spanish Agency of Medicines

Keywords provided by Amylin Pharmaceuticals, Inc.:

exenatide
exendin-4
diabetes
Amylin
Lilly

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
2,4-thiazolidinedione
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009