Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
NCT ID: NCT01046422
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2010-05-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BMS-770767 ± metformin (Treatment A)
BMS-770767
Capsule, Oral, 15mg, Active, Daily, 28 days
Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
BMS-770767 ± metformin (Treatment B)
BMS-770767
Capsule, Oral, 50mg, Active, Daily, 28 days
Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
BMS-770767 ± metformin (Treatment C)
BMS-770767
Capsule, Oral, 150mg, Active, Daily, 28 days
Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
BMS-770767 ± metformin (Treatment D)
BMS-770767
Capsule, Oral, 50mg BID, Active, Daily, 28 days
Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
Placebo ± metformin (Treatment E)
Placebo
Capsule, Oral, 0mg, Daily, 28 days
Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
Interventions
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BMS-770767
Capsule, Oral, 15mg, Active, Daily, 28 days
BMS-770767
Capsule, Oral, 50mg, Active, Daily, 28 days
BMS-770767
Capsule, Oral, 150mg, Active, Daily, 28 days
BMS-770767
Capsule, Oral, 50mg BID, Active, Daily, 28 days
Placebo
Capsule, Oral, 0mg, Daily, 28 days
Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
Eligibility Criteria
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Inclusion Criteria
* HbA1c ≥ 7.0% and ≤ 10.0% with FPG ≤ 240mg/dL (13.3 mmol/dL)
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2009-014308-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MB117-003
Identifier Type: -
Identifier Source: org_study_id
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