| Outcome Measures: |
Primary: Number of Participants With Adverse Drug Reactions, Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions., For 12 months | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1c), Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement., Baseline, and Months 3, 6, 9, 12 and at Final Assessment|Glycosylated Hemoglobin (HbA1c), Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline., Baseline, and Months 3, 6, 9, 12 and at Final Assessment|Change From Baseline in Fasting Blood Glucose Level, Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement., Baseline, Months 3, 6, 9, 12 and at Final Assessment|Fasting Blood Glucose Level, Tabulated fasting blood glucose level from baseline at each test time point., Baseline, Months 3, 6, 9, 12 and at Final Assessment|Change From Baseline in Fasting Insulin Level, Tabulated the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement., Baseline, Months 3, 6, 9, 12 and at Final Assessment|Fasting Insulin Level, Tabulated fasting insulin level at each test time point., Baseline, Months 3, 6, 9, 12 and at Final Assessment
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