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

Tracking Information

First Received Date ^ICMJE

July 26, 2007

Last Updated Date

March 13, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Safety: incidence of adverse events [ Time Frame: from subject enrollment to study discharge ]

Change History

Complete list of historical versions of study NCT00508287 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: A
Intervention: Drug: BMS-686117
Active Comparator: B
Intervention: Drug: Byetta
Placebo Comparator: C
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00508287

Other Study ID Numbers ^ICMJE

MB110-005

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

March 2009

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

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