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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Byetta; Drug: BMS-686117; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00508287

MB110-005

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 3 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: BMS-686117

B

Active Comparator group

Treatment:

Drug: Byetta

C

Placebo Comparator group

Treatment:

Drug: Placebo