Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)

• Fasting plasma glucose: 126 - 240 mg/dL

• Hemoglobin A1c: 6 - 10%

• Estimated CrCl ≥ 60 mL/min

• ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN

• Stable and well controlled hypertension and/or dyslipidemia

• Concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks

Exclusion Criteria:

• Women of childbearing potential

• Symptomatic diabetes with polyuria and/or polydipsia

• History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome

• History of renal disease including diabetic nephropathy