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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
History of Changes
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
 Drug: BMS-686117
Drug: Byetta
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety: incidence of adverse events [ Time Frame: from subject enrollment to study discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: BMS-686117
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
Active Comparator: B Drug: Byetta
Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
Placebo Comparator: C Drug: Placebo
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508287

Locations
United States, Florida
Elite Research Institute
Miami, Florida, United States, 33169
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Tennessee
New Orleans Center For Clinical Research
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00508287     History of Changes
Other Study ID Numbers: MB110-005
Study First Received: July 26, 2007
Last Updated: March 13, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013