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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00508287
First received: July 26, 2007
Last updated: March 13, 2009
Last verified: March 2009

July 26, 2007
March 13, 2009
August 2007
November 2007   (final data collection date for primary outcome measure)
Safety: incidence of adverse events [ Time Frame: from subject enrollment to study discharge ] [ Designated as safety issue: Yes ]
Safety: incidence of adverse events [ Time Frame: from subject enrollment to study discharge ]
Complete list of historical versions of study NCT00508287 on ClinicalTrials.gov Archive Site
  • PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF [ Time Frame: from pre-dose to 24 hrs post-dose ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: from pre-dose to 9 hrs post-dose ] [ Designated as safety issue: No ]
  • PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF [ Time Frame: 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 [ Time Frame: from pre-dose to 9 hrs post-dose ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: BMS-686117
    Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
  • Drug: Byetta
    Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
  • Drug: Placebo
    Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
  • Experimental: A
    Intervention: Drug: BMS-686117
  • Active Comparator: B
    Intervention: Drug: Byetta
  • Placebo Comparator: C
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00508287
MB110-005
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP