A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects
NCT ID: NCT00162305
Last Updated: 2016-10-27
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
47 participants
INTERVENTIONAL
2005-04-30
2005-08-31
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
DOUBLE
Study Groups
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1
BMS-512148
Capsules, Oral, 100 mg, Once daily, 14 days.
2
BMS-512148
Capsules, Oral, 25 mg, Once daily, 14 days.
3
BMS-512148
Capsules, Oral, 5 mg, Once daily, 14 days.
4
Placebo
Capsules, Oral, 0 mg, Once daily, 14 days.
Interventions
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BMS-512148
Capsules, Oral, 100 mg, Once daily, 14 days.
BMS-512148
Capsules, Oral, 25 mg, Once daily, 14 days.
BMS-512148
Capsules, Oral, 5 mg, Once daily, 14 days.
Placebo
Capsules, Oral, 0 mg, Once daily, 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fasting glucose (FG) \< - 240 mg/dL, while on metformin or antidiabetic diet alone.
* HbA1c (Hemoglobin A1c) in the range of 6.0-10.0%
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
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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Local Institution
Fort Lauderdale, Florida, United States
Local Institution
Miami, Florida, United States
Local Institution
Orlando, Florida, United States
Local Institution
New Orleans, Louisiana, United States
Local Institution
San Antonio, Texas, United States
Countries
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References
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Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009 May;85(5):513-9. doi: 10.1038/clpt.2008.250. Epub 2009 Jan 7.
Related Links
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Other Identifiers
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MB102-003
Identifier Type: -
Identifier Source: org_study_id