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

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 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 ]
Change in body weight from baseline after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0)

Secondary Outcome Measures:

Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in HbA1c from baseline after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
Change in 6-point Self Monitored Blood Glucose (SMBG) Profile. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0)
Change in Waist Circumference. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0)
Change in Homeostatic Model Assessment-Beta Cell (HOMA-B) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.
Change in Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.
Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)
Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in LDL cholesterol from baseline after 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)
Change in Total Cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
Change in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Ratio of triglyceride levels at week 24 to triglyceride levels at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)
Incidence of Hypoglycemic Events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Number of patients experiencing one or more events of hypoglycemia at any point in the study
Rate of Hypoglycemic Events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Overall rate of hypoglycemia, adjusted for 1 year (i.e., events of hypoglycemia per patient per year)

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
Experimental: Group A	Drug: exenatide subcutaneous injection, 5mcg or 10mcg, twice a day Other Name: Byetta
Placebo Comparator: Group B	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
Jacksonville, Florida, United States
Research Site
Orlando, 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:	James Malone, MD, Study Director, Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00375492 History of Changes
Other Study ID Numbers:	H8O-US-GWBM
Study First Received:	September 11, 2006
Results First Received:	February 25, 2009
Last Updated:	July 1, 2010
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:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes

Body Weight
Signs and Symptoms
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012