Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
- Registration Number
- NCT01046422
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine if BMS-770767 is safe, well tolerated, measure its levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
- Diagnosed with type 2 diabetes with inadequate glycemic control and treated with either diet and exercise alone, or with stable doses (≥ 1500mg/d) of metformin for at least 8 weeks prior to screening
- HbA1c ≥ 7.0% and ≤ 10.0% with FPG ≤ 240mg/dL (13.3 mmol/dL)
Exclusion Criteria
- Women of childbearing potential
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Significant cardiovascular history
- History of unstable or rapidly progressing renal disease
- Impaired renal function defined by a serum creatinine > 1.4mg/dL (124 µmol/L) for women and >1.5mg/dL (133 µmol/L) for men
- Active liver disease and /or significant abnormal liver function defined as AST > 3X ULN and/or ALT > 3XULN and /or serum total bilirubin > 2.0mg/dl
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-770767 ± metformin (Treatment A) BMS-770767 - BMS-770767 ± metformin (Treatment A) Metformin - BMS-770767 ± metformin (Treatment B) BMS-770767 - BMS-770767 ± metformin (Treatment B) Metformin - BMS-770767 ± metformin (Treatment C) BMS-770767 - BMS-770767 ± metformin (Treatment C) Metformin - BMS-770767 ± metformin (Treatment D) BMS-770767 - Placebo ± metformin (Treatment E) Placebo - BMS-770767 ± metformin (Treatment D) Metformin - Placebo ± metformin (Treatment E) Metformin -
- Primary Outcome Measures
Name Time Method Fasting Plasma Glucose Improvement Within seven days following dosing
- Secondary Outcome Measures
Name Time Method Mean daily glucose (3-day 7 pt-fingerstick) Within 28 days following dosing Four (4)-hour post-prandial glucose AUC Within 28 days following dosing HbA1C Within 28 days following dosing Lipid profiles Within 28 days following dosing
Trial Locations
- Locations (3)
Nevada Alliance Against Diabetes
🇺🇸Las Vegas, Nevada, United States
Marina Raikhel, Md
🇺🇸Lomita, California, United States
Local Institution
🇰🇷Suwon, Korea, Republic of