Effect on Weight Loss of Exenatide Versus Placebo - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2006

Last Updated Date

July 30, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00375492 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

Effect on Weight Loss of Exenatide Versus Placebo

Official Title ^ICMJE

Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: exenatide
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

190

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00375492

Responsible Party

James Malone, MD, Study Director, Eli Lilly and Company

Study ID Numbers ^ICMJE

H8O-US-GWBM

Study Sponsor ^ICMJE

Amylin Pharmaceuticals, Inc.

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Study Director:

James Malone, MD

Eli Lilly and Company

Information Provided By

Amylin Pharmaceuticals, Inc.

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP