Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
1 other identifier
interventional
36
1 country
3
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes
Started Aug 2007
Shorter than P25 for phase_1 type-2-diabetes
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2007
CompletedFirst Posted
Study publicly available on registry
July 27, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedMarch 16, 2009
March 1, 2009
3 months
July 26, 2007
March 13, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: incidence of adverse events
from subject enrollment to study discharge
Secondary Outcomes (2)
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 Arms (3)
A
EXPERIMENTALB
ACTIVE COMPARATORC
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Elite Research Institute
Miami, Florida, 33169, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
New Orleans Center For Clinical Research
Knoxville, Tennessee, 37920, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 26, 2007
First Posted
July 27, 2007
Study Start
August 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
March 16, 2009
Record last verified: 2009-03