Safety Study of BMS-770767 in Subjects With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Type 2

In brief

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

Key facts

Study ID

NCT01046422

Run by

Bristol-Myers Squibb

People needed

76

Starts

2010-05-01

Expected to finish

2011-01-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Marina Raikhel, Md — Lomita, California, United States
• Nevada Alliance Against Diabetes — Las Vegas, Nevada, United States
• Local Institution — Caboolture, Queensland, Australia
• Local Institution — Meadowbrook, Queensland, Australia
• Local Institution — Daw Park, South Australia, Australia
• Local Institution — Geelong, Victoria, Australia
• Local Institution — Nedlands, Western Australia, Australia
• Local Institution — Winnipeg, Manitoba, Canada
• Local Institution — Mount Pearl, Newfoundland and Labrador, Canada
• Local Institution — Brampton, Ontario, Canada
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Charlottetown, Prince Edward Island, Canada
• Local Institution — Drummondville, Quebec, Canada
• Local Institution — Lachine, Quebec, Canada
• Local Institution — Laval, Quebec, Canada
• Local Institution — Montreal, Quebec, Canada
• Local Institution — Incheon, South Korea
• Local Institution — Suwon, South Korea

Full record on ClinicalTrials.gov

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