Effect on Weight Loss of Exenatide Versus Placebo - Full Text View

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

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