| Outcome Measures: |
Primary: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is 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; or congenital anomaly; or a medically important event., Baseline up to 30 days after the last dose of study drug (up to 30 weeks)|Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs, An ADR is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases or for the restoration, correction or modification of physiological function. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility., Baseline up to 30 days after the last dose of study drug (up to 30 weeks)|Change from Baseline in Glycosylated Haemoglobin (HbA1c) at Weeks 13 and 26, 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 weeks 13 and 26 relative to Baseline., Baseline and Weeks 13 and 26|Percentage of Participants with Glycosylated Hemoglobin < 7.0%, Clinical response at Weeks 13 and 26 will be assessed by the percentage of participants with HbA1c less than 7%., Weeks 13 and 26 |
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