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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: BMS-686117; Drug: Byetta; Drug: Placebo

• Registration Number: NCT00508287
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-27
• Study Start: 2007-08
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	BMS-686117	-
B	Byetta	-
C	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety: incidence of adverse events	from subject enrollment to study discharge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

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