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An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

This study has been completed.

Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00135330
  Purpose

This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.


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

MedlinePlus related topics:   Diabetes   

ChemIDplus related topics:   Exenatide    Metformin    Metformin hydrochloride    Rosiglitazone    Rosiglitazone Maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

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

Primary Outcome Measures:
  • To test the hypothesis that in patients with type 2 diabetes who have not achieved adequate glycemic control with metformin treatment, the addition of exenatide and rosiglitazone will provide superior beta-cell function [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the effects of exenatide, rosiglitazone, and a combination of exenatide and rosiglitazone in subjects with type 2 diabetes treated with metformin on various pharmacodynamic measurements and safety and tolerability [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Compare total insulin secretion between the exenatide group, rosiglitazone group, and the exenatide plus rosiglitazone group [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   140
Study Start Date:   October 2005
Study Completion Date:   July 2008
Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
2: Experimental Drug: rosiglitazone
oral tablet, 2mg or 4mg, twice a day
3: Experimental Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Drug: rosiglitazone
oral tablet, 2mg or 4mg, twice a day

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • HbA1c of 6.8% to 10.0%, inclusive.
  • Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.

Exclusion Criteria:

  • Have participated in this study previously, or have received exenatide, pramlintide acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors
  • Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.
  • Treated with any of the following medications:

    • Thiazolidinedione within 5 months of screening;
    • Sulfonylurea within 3 months of screening;
    • Metformin/sulfonylurea combination therapy within 3 months of screening;
    • Alpha-glucosidase inhibitor within 3 months of screening;
    • Meglitinide within 3 months of screening;
    • Insulin for more than 1 week within the 3 months prior to screening.
    • Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time
    • Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility
    • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
    • Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer
    • Systemic antineoplastic agent
    • Systemic transplantation medication
    • Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135330

Locations
United States, Arizona
Research Site    
      Phoenix, Arizona, United States
United States, California
Research Site    
      San Francisco, California, United States
United States, Florida
Research Site    
      Orlando, Florida, United States
Research Site    
      Jacksonville, Florida, United States
United States, Georgia
Research Site    
      Atlanta, Georgia, United States
United States, Hawaii
Research Site    
      Honolulu, Hawaii, United States
United States, Indiana
Research Site    
      Indianapolis, Indiana, United States
United States, Massachusetts
Research Site    
      Boston, Massachusetts, United States
Research Site    
      Pittsfield, Massachusetts, United States
United States, Minnesota
Research Site    
      Rochester, Minnesota, United States
Research Site    
      Minneapolis, Minnesota, United States
United States, New York
Research Site    
      Bronx, New York, United States
Research Site    
      Syracuse, New York, United States
United States, Ohio
Research Site    
      Cincinatti, Ohio, United States
United States, Texas
Research Site    
      League City, Texas, United States
Research Site    
      San Antonio, Texas, United States
Research Site    
      New Braunfels, Texas, United States
United States, Washington
Research Site    
      Renton, Washington, United States
Research Site    
      Spokane, Washington, United States

Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company

Investigators
Study Director:     James Malone, MD     Eli Lilly and Company    
  More Information

Responsible Party:   Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:   H8O-US-GWAY
First Received:   August 24, 2005
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00135330
Health Authority:   United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:
diabetes  
exenatide  
rosiglitazone  
Amylin  
Lilly  

Study placed in the following topic categories:
Metabolic Diseases
Exenatide
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008




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