NCT00508287CompletedPhase 1
Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
Bristol-Myers Squibb3 sites in 1 country36 target enrollmentStarted: August 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 3
- Primary Endpoint
- Safety: incidence of adverse events
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Intervention: BMS-686117 (Drug)
B
Active Comparator
Intervention: Byetta (Drug)
C
Placebo Comparator
Intervention: Placebo (Drug)
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)
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Completed
Phase 1
A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy VolunteersGaucher DiseaseNCT01881633ISU Abxis Co., Ltd.24
Completed
Phase 1
Single-Dose Study of MT203Healthy VolunteersNCT02354599Takeda32
Completed
Phase 1
Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg VirusMarburg Hemorrhagic FeverNCT01353040Sarepta Therapeutics, Inc.30
Completed
Phase 1
SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy SubjectsHealthyNCT02657122Theravance Biopharma72
Completed
Phase 1
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian ParticipantsHealthy VolunteersNCT05806359Bristol-Myers Squibb33