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Effect on Weight Loss of Exenatide Versus Placebo

This study has been completed.

Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00375492
  Purpose

This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide
Drug: placebo
Phase IV

MedlinePlus related topics:   Diabetes    Obesity    Weight Control   

ChemIDplus related topics:   Exenatide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program

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

Primary Outcome Measures:
  • To test the hypothesis that treatment with exenatide plus caloric restriction and physical activity will result in greater weight loss in overweight or obese subjects with type 2 diabetes than placebo plus caloric restriction and physical activity. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare exenatide and placebo with respect to the following: hemoglobin A1c, self-monitored blood glucose, lipids, waist circumference, beta cell function and insulin sensitivity, incidence/rate of hypoglycemic events, and adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   190
Study Start Date:   September 2006
Study Completion Date:   February 2008
Primary Completion Date:   February 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: Placebo Comparator Drug: placebo
subcutaneous injection, volume equivalent to exenatide dose, 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:

  • Diagnosed with type 2 diabetes for at least 6 months
  • Have been treated with a stable dose of the following for at least 6 weeks prior to screening: *immediate or extended release metformin, or *a sulfonylurea, or *a fixed-dose sulfonylurea/metformin combination therapy
  • Have an HbA1c of 6.6% to 10.0%, inclusive
  • Have a Body Mass Index (BMI) of 25 kg/m^2 to 39.9 kg/m^2, inclusive

Exclusion Criteria:

  • Are treated with any of the following excluded medications: *exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; *Symlin injection at any time; * Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; *drugs that directly affect gastrointestinal motility; *use of a weight loss drug (including those available over the counter) within 3 months of screening; *chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening
  • Have conditions contraindicating metformin and/or sulfonylurea use
  • Have had a change in lipid-lowering agents within 6 weeks of screening
  • Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV inhibitors (DPP-IV inhibitors) or have previously participated in this study
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375492

Locations
United States, Arizona
Research Site    
      Peoria, Arizona, United States
United States, Florida
Research Site    
      Orlando, Florida, United States
Research Site    
      Jacksonville, Florida, United States
United States, Indiana
Research Site    
      Indianapolis, Indiana, United States
United States, Massachusetts
Research Site    
      Boston, Massachusetts, United States
United States, Minnesota
Research Site    
      Minneapolis, Minnesota, United States
United States, Missouri
Research Site    
      St. Louis, Missouri, United States
United States, South Carolina
Research Site    
      Spartanburg, South Carolina, United States
United States, Texas
Research Site    
      San Antonio, Texas, United States
United States, Washington
Research Site    
      Renton, 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-GWBM
First Received:   September 11, 2006
Last Updated:   June 24, 2008
ClinicalTrials.gov Identifier:   NCT00375492
Health Authority:   United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:
diabetes  
overweight  
obesity  
weight loss  
exenatide
Amylin
Lilly

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Exenatide
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus, Type 2
Weight Loss
Body Weight Changes
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

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

ClinicalTrials.gov processed this record on September 05, 2008




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