An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: exenatide (Drug); rosiglitazone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Amylin Pharmaceuticals, Inc.

Official(s) and/or principal investigator(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 protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.

Official title: An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To test the hypothesis that in patients with type 2 diabetes who have not achieved adequate glycemic control with metformin treatment, the addition of exenatide and rosiglitazone will provide superior beta-cell function

Secondary outcome:

Compare the effects of exenatide, rosiglitazone, and a combination of exenatide and rosiglitazone in subjects with type 2 diabetes treated with metformin on various pharmacodynamic measurements and safety and tolerability

Compare total insulin secretion between the exenatide group, rosiglitazone group, and the exenatide plus rosiglitazone group

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HbA1c of 6. 8% to 10. 0%, inclusive.

- Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.

Exclusion Criteria:

- Have participated in this study previously, or have received exenatide, pramlintide

acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors

- Have participated in an interventional, medical, surgical, or pharmaceutical study (a

study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.

- Treated with any of the following medications:

- Thiazolidinedione within 5 months of screening;

- Sulfonylurea within 3 months of screening;

- Metformin/sulfonylurea combination therapy within 3 months of screening;

- Alpha-glucosidase inhibitor within 3 months of screening;

- Meglitinide within 3 months of screening;

- Insulin for more than 1 week within the 3 months prior to screening.

- Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any

time

- Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a

drug that directly affects gastrointestinal motility

- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid

therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start

- Regular use of a medication with addictive potential such as an opiate, narcotic,

or tranquilizer

- Systemic antineoplastic agent

- Systemic transplantation medication

- Drugs for weight loss, including over-the-counter medications, within the 4

months prior to study start

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

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

Research Site, San Francisco, California, 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, Atlanta, Georgia, United States; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

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

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

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

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

Research Site, League City, Texas, 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, New Braunfels, 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)

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

Starting date: October 2005
Ending date: September 2008
Last updated: December 20, 2007