A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: 2,4-thiazolidinedione; Exenatide; Metformin; Pioglitazone; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Has been diagnosed with type 2 diabetes mellitus

• Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start

• Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start

• Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start

• Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:

1. Hormone replacement therapy (female subjects)

2. Oral contraceptives (female subjects)

3. Antihypertensive agents

4. Lipid-lowering agents

5. Thyroid replacement therapy

6. Antidepressant agents

7. Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents

Exclusion Criteria:

• Has been previously exposed to exenatide once weekly

• Has donated blood within 60 days of study start or is planning to donate blood during the study

• Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:

1. Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start

2. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start

3. Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start

4. Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption

5. Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin

• Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start

• Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use