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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00508287
• Collaborator: (none)
• Enrollment: 36
• Locations: 3
• Arms: 3
• Duration (Months): 3
• Patients Per Site: 12
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: BMS-686117; Drug: Byetta; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, 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
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Safety: incidence of adverse events [from subject enrollment to study discharge]

Secondary Outcome Measures

1. PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF [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 [from pre-dose to 9 hrs post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Elite Research Institute	Miami	Florida	United States	33169
2	Orlando Clinical Research Center	Orlando	Florida	United States	32809
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00508287
• Other Study ID Numbers: MB110-005
• First Posted: Jul 27, 2007
• Last Update Posted: Mar 16, 2009
• Last Verified: Mar 1, 2009

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Exenatide

Study Results

No Results Posted as of Mar 16, 2009