Condition(s) treated: Type 2 Diabetes Mellitus

Intervention: exenatide (Drug)

Phase: Phase 4

Enrollment status: Recruiting. Expecting to enroll 190 people.

Sponsor: Amylin Pharmaceuticals

Principal investigator(s) or official(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company

Overall contact:
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

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.

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: 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.

Minimum eligible age: 18 Years. Maximum eligible age: 75 Years. Eligible gender(s): Both.

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

Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, Peoria, Arizona, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, Orlando, Florida, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, Jacksonville, Florida, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, Indianapolis, Indiana, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, Boston, Massachusetts, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, Minneapolis, Minnesota, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, St. Louis, Missouri, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, Spartanburg, South Carolina, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, San Antonio, Texas, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Research Site, Renton, Washington, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY(1-877-285-4559)

Start date: September 2006
Last updated: November 7, 2006