| Outcome Measures: |
Primary: Number of Participants Reporting One or More Adverse Drug Reactions, Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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., Baseline up to 12 months|Number of Participants Reporting One or More Serious Adverse Drug Reactions, Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly., Baseline up to 12 months | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1c), 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 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline., Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|Change From Baseline in Fasting Blood Glucose, The change between the fasting blood glucose value collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline., Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|Change From Baseline in Body Weight, Change relative to baseline in participant's weight measured at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12)., Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|Change From Baseline in Immunoreactive Insulin (IRI), The change in the value of IRI (portion of insulin in blood measured by immunochemical methods for the hormone; presumed to represent the free \[unbound\] and biologically active fraction of total blood insulin) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline., Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), The change between homeostasis model assessment of insulin resistance collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. Homeostasis Model assessment of insulin resistance Measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5). A higher score indicates higher insulin resistance., Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
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