The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
389
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Tablets, Oral, 5 mg, Once daily, 12 weeks.
Tablets, Oral, 10 mg, Once daily, 12 weeks.
Mean change from baseline in HbA1c compared to placebo.
Time frame: at 12 weeks
Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion
Time frame: at Weeks 6 and 12
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Tablets, Oral, 20 mg, Once daily, 12 weeks.
Tablets, Oral, 50 mg, Once daily, 12 weeks.
Tablets, Oral, 0 mg, Once daily, 12 weeks.
Tablets, Oral, \>/= 1500 mg, Once daily, 12 weeks.
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Bayou La Batre, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Tucson, Arizona, United States
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Fayetteville, Arkansas, United States
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Hot Springs, Arkansas, United States
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Beverly Hills, California, United States
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Long Beach, California, United States
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