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Completed

NCT Number: NCT00508287

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Elite Research Institute, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-686117

Drug

Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.

Byetta

Drug

Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.

Placebo

Drug

Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.

Primary outcomes

  1. Safety: incidence of adverse events

    Time frame: from subject enrollment to study discharge

Secondary outcomes

  1. PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF

    Time frame: from pre-dose to 24 hrs post-dose

  2. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 27, 2007
Registry last updated
Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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