Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | May 2010 |
| End Date: | January 2011 |
A Double-blind, Placebo-Controlled, Parallel-group, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Either Diet and Exercise Alone or on a Background of Metformin
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
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
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
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