Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85., The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline., Baseline and Day 85. | Secondary: Change From Baseline in Glycosylated Hemoglobin at Day 43., The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline., Baseline and Day 43.|Change From Baseline in Fasting Plasma Glucose (Day 43)., The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline., Baseline and Day 43|Change From Baseline in Fasting Plasma Glucose (Day 85)., The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline., Baseline and Day 85.|Change From Baseline in Fasting Fructosamine (Day 43)., The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline., Baseline and Day 43.|Change From Baseline in Fasting Fructosamine (Day 85)., The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline., Baseline and Day 85.|Change From Baseline in Total Cholesterol (Day 43)., The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline., Baseline and Day 43|Change From Baseline in Total Cholesterol (Day 85)., The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline., Baseline and Day 85.|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43)., The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline., Baseline and Day 43.|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85)., The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline., Baseline and Day 85.|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43)., The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline., Baseline and Day 43.|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85)., The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline., Baseline and Day 85.|Change From Baseline in Triglycerides (Day 43)., The change between triglycerides collected at day 43 and triglycerides collected at baseline., Baseline and Day 43.|Change From Baseline in Triglycerides (Day 85)., The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline., Baseline and Day 85.|Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL)., The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population., 85 Days.
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