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

Completed · Phase 1 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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

Key facts

Study ID

NCT00508287

Run by

Bristol-Myers Squibb

People needed

36

Starts

2007-08-01

Expected to finish

2007-11-01

Last updated by the study team

2009-03-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Elite Research Institute — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• New Orleans Center For Clinical Research — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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