| Outcome Measures: |
Primary: Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6, The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward., Baseline to Month 6 post-dose | Secondary: Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12, The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward., Baseline to Month 12 post-dose|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12, Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points., Baseline to Month 12 post-dose|Number of Participants Achieving a Response to Therapy to Month 12, Participants achieving a response to therapy, ie, glycemic control, were assessed with the last observation after 1 month before any rescue therapy carried forward at Month 6 and Month 12. Response to therapy was defined as HbA1c \<7.0% or \<6.5%, reduction in HbA1c ≥0.7% or ≥0.5% from baseline, and/or reduction in FPG ≥30 mg/dL from baseline., Baseline to Month 12 post-dose|Percent Change From Baseline to Month 6 in Plasma Lipids, The percent change in plasma lipids from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward., Baseline to Month 6 post-dose|Percent Change From Baseline to Month 6 in Triglycerides, The percent change in triglycerides from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward., Baseline to Month 6 post-dose|Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria, Rescue criteria was defined as HbA1c levels ≥8.5% after 3 months or ≥7.5% after 6 months (≥173 days) (confirmed persistent hyperglycemia) of study medication treatment, as measured by the central laboratory., Baseline to Month 12 post-dose
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| Locations: |
Tucson, Arizona, 85724, United States|Little Rock, Arkansas, 72202, United States|Los Angeles, California, 90027, United States|Oakland, California, 94609, United States|San Diego, California, 92123, United States|Aurora, Colorado, 80045, United States|Hartford, Connecticut, 06106, United States|Tampa, Florida, 33612, United States|Atlanta, Georgia, 30322, United States|Chicago, Illinois, 60637, United States|Kansas City, Kansas, 66160, United States|Baltimore, Maryland, 21229, United States|Springfield, Massachusetts, 01199, United States|New York, New York, 10032, United States|Raleigh, North Carolina, 27610, United States|Cincinnati, Ohio, 45229, United States|Oklahoma City, Oklahoma, 73104, United States|Oklahoma City, Oklahoma, 73112, United States|Philadelphia, Pennsylvania, 19104, United States|Greenville, South Carolina, 29615, United States|Nashville, Tennessee, 37232, United States|Dallas, Texas, 75235, United States|Houston, Texas, 77030, United States|San Antonio, Texas, 78207, United States
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