| Outcome Measures: |
Primary: Mean Change From Randomization in A1c at Week 26, Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy, Baseline and Week 26 | Secondary: Composite End-point, Percentage of participants with glycosylated Hemoglobin A1c (A1c)\<8% AND no documented severe hypoglycemia (\<56 mg/dL) during the study AND no significant weight gain (\>3% from baseline), Week 0 (Randomization) , Week 26|Percentage of Participants Reaching Target A1c of <7% at Week 26, Week 26|Percentage of Participants Reaching Pre-specified "Treatment Failure" Outcome, Treatment Failure defined as A1c\>10% at week 13 (visit 5), week 13|Mean Change From Randomization in Body Weight, Change in body weight from randomization to end of study., Week 0 (Randomization) , Week 26|Hypoglycemic Episodes, Percentage of participants experiencing any episodes of documented hypoglycemia defined as CBG reading of \<70 mg/dl, Week 0 (Randomization) , Week 2, week 4, week 13, Week 26|Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means, Diabetes Quality of Life (DQOL) questionnaires will be completed by the patient at the randomization and end-of study visits. ALL D-QOL domains are scored on a 1-5 scale, with a lower number representing better quality of life or treatment satisfaction. Outcome reported is difference between mean baseline and mean Week 26 score., Week 0 (Randomization) , Week 26|Change in Short Form-36 (SF-36) Questionnaire Score, Quality of life questionnaires will be completed by the patient at the randomization and end-of study visits. SF-36 is scored on a 1-100 scale; a higher score represents a better self-assessed health - for all domains., Week 0 (Randomization) , Week 26
|
