| Outcome Measures: |
Primary: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Change in HbA1c from Baseline to Week 24, Baseline, Week 24 | Secondary: Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less, Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less, Baseline, Weeks 4, 8, 12, 16, 24|Change in fasting serum glucose (FSG) from Baseline to Week 24, Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between, Baseline, Weeks 4, 8, 12, 16, and 24|Change in body weight from Baseline to Week 24, Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between, Baseline, Weeks 4, 8, 12, 16, and 24|Change in glucose measurements from Baseline to Week 24, Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between, Baseline, Weeks 4, 8, 12, 16, 24|Changes in beta-cell function and insulin sensitivity from Baseline to Week 24, Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between, Baseline, Weeks 4, 8, 12, 16, and 24|Changes in fasting and 30, 60, 120 and 180-minute glucose measurements, Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin, Immediately before glucose load, then 30, 60, 120, and 180 minutes post
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| Locations: |
Research Site, Idaho Falls, Idaho, United States|Research Site, Indianapolis, Indiana, United States|Research Site, Aligarh, India|Research Site, Bangalore, India|Research Site, Chennai, India|Research Site, Indore, India|Research Site, Karnal, India|Research Site, New Delhi, India|Research Site, Vellore, India|Research Site, Manati, Puerto Rico|Research Site, San Juan, Puerto Rico|Research Site, Alba Iulia, Romania|Research Site, Baia Mare, Romania|Research Site, Bucuresti, Romania|Research Site, Galati, Romania|Research Site, Oradea, Romania|Research Site, Targu Mures, Romania|Research Site, Moscow, Russian Federation|Research Site, St. Petersburg, Russian Federation
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