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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508287
• Other study ID #: MB110-005
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2007
• Last updated: March 13, 2009
• Start date: August 2007
• Est. completion date: November 2007

Study information

• Verified date: March 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• BMS-686117
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
• Byetta
Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
• Placebo
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.

Locations

Country	Name	City	State
United States	New Orleans Center For Clinical Research	Knoxville	Tennessee
United States	Elite Research Institute	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: incidence of adverse events		from subject enrollment to study discharge	Yes
Secondary	PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF		from pre-dose to 24 hrs post-dose	No
Secondary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm