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Effect on Weight Loss of Exenatide Versus Placebo
This study has been completed.
First Received: September 11, 2006   Last Updated: July 30, 2009   History of Changes
Sponsor: Amylin Pharmaceuticals, Inc.
Collaborator: 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

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity Weight Control
Drug Information available for: Exenatide
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in 6-point Self Monitored Blood Glucose (SMBG) Profile. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Waist Circumference. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Homeostatic Model Assessment-Beta Cell (HOMA-B) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Total Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of Hypoglycemic Events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of Hypoglycemic Events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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
Group A: Experimental Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Group B: 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

No publications provided

Responsible Party: Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers: H8O-US-GWBM
Study First Received: September 11, 2006
Results First Received: February 25, 2009
Last Updated: July 30, 2009
ClinicalTrials.gov Identifier: NCT00375492     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Pharmacologic Actions
Body Weight
 Signs and Symptoms
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Weight Loss
Body Weight Changes
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009



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