| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1C (A1C) at Week 54, A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent., Baseline and Week 54|Percentage of Participants Who Experienced at Least One Adverse Event, An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions., Up to 57 weeks (including 3 weeks following the last dose of study drug)|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event, An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions., Up to 54 weeks | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54, This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0., Baseline and Week 54|Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment, Percentage of participants achieving glycemic goal (A1C \<7% or \<6.5%) after 54 weeks of treatment., 54 weeks|Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment, Percentage of Participants who had an A1C decrease \>0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment, 54 weeks|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia, An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported., Up to 54 weeks|Change From Baseline in Body Weight at Week 54, Body weight was to be measured (in duplicate) using a calibrated digital scale., Baseline and Week 54
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