| 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., 12 months | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1c), Tabulation of the HbA1c test value and change 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. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data., Baseline and Months 3, 6, 9, 12 and final assessment|Change From Baseline in Fasting Blood Glucose, Tabulation of fasting blood glucose test values and change 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. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data., Baseline and Months 3, 6, 9, 12 and final assessment|Change From Baseline in Fasting Insulin, Tabulation of fasting insulin test values and change 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. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data., Baseline and Months 3, 6, 9, 12 and final assessment
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