| Outcome Measures: |
Primary: Change From Baseline in Body Weight, Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k)., Baseline, Week 24 | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24, Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin., baseline, Week 24|Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24, Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L)., baseline, Week 24|Change From Baseline in Waist Circumference at Week 24, Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm)., baseline, Week 24|Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline, Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant., baseline, Week 24|Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline, Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant., baseline, Week 24|Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24, Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L., baseline, Week 24|Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24, Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L, baseline, Week 24|Change From Baseline in Total Cholesterol at Week 24, Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L., baseline, week 24|Ratio of Triglycerides at Week 24 to Triglycerides at Baseline, Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L., baseline, Week 24|Number of Participants With Hypoglycemic Events During the Study, Number of participants experiencing one or more events of hypoglycemia at any point in the study, Baseline to 24 weeks|Rate of Hypoglycemic Events, Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year)., 24 weeks
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| Locations: |
Research Site, Peoria, Arizona, United States|Research Site, Jacksonville, Florida, United States|Research Site, Orlando, Florida, United States|Research Site, Indianapolis, Indiana, United States|Research Site, Boston, Massachusetts, United States|Research Site, Minneapolis, Minnesota, United States|Research Site, St. Louis, Missouri, United States|Research Site, Spartanburg, South Carolina, United States|Research Site, San Antonio, Texas, United States|Research Site, Renton, Washington, United States
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