NCT00508287
Completed
Phase 1
Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
Overview
- Phase
- Phase 1
- Intervention
- BMS-686117
- Conditions
- Type 2 Diabetes
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 36
- Locations
- 3
- Primary Endpoint
- Safety: incidence of adverse events
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117
Investigators
Eligibility 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
Arms & Interventions
A
Intervention: BMS-686117
B
Intervention: Byetta
C
Intervention: Placebo
Outcomes
Primary Outcomes
Safety: incidence of adverse events
Time Frame: from subject enrollment to study discharge
Secondary Outcomes
- PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF(from pre-dose to 24 hrs post-dose)
- PD Measures: Fasting and postprandial serum glucose (AUC), serum insulin, and plasma glucagon concentrations. Acetaminophen plasma concentrations will be measured after a single dose of acetaminophen(from pre-dose to 9 hrs post-dose)
Study Sites (3)
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