| Outcome Measures: |
Primary: Percentage of Patients Experiencing Adverse Events, Percentage of patients experiencing treatment-emergent adverse events over 52 weeks, Baseline to Week 52|Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events, Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2)., Baseline to Week 52 | Secondary: Change in HbA1c From Baseline to Week 52, Change in HbA1c from baseline to endpoint, Baseline, Week 52|Percentage of Patients Achieving HbA1c <=7% at Week 52, Percentage of patients achieving HbA1c \<=7% at endpoint (for patients with HbA1c \>7% at baseline), Baseline, Week 52|Percentage of Patients Achieving HbA1c <=6.5% at Week 52, Percentage of patients achieving HbA1c \<=6.5% at endpoint (for patients with HbA1c \>6.5% at baseline), Baseline, Week 52|Change in Fasting Serum Glucose From Baseline to Week 52, Change in fasting serum glucose from baseline to endpoint, Baseline, Week 52|Change in Body Weight From Baseline to Week 52, Change in body weight from baseline to endpoint, Baseline, Week 52|Change in Total Cholesterol From Baseline to Week 52, Change in Total Cholesterol from baseline to endpoint, Baseline, Week 52|Change in High-density Lipoprotein (HDL) From Baseline to Week 52, Change in HDL from baseline to endpoint, Baseline, Week 52|Change in Triglycerides From Baseline to Week 52, Change in Triglycerides from baseline to endpoint, Baseline, Week 52|Change in Blood Pressure From Baseline to Week 52, Change in Systolic and Diastolic Blood Pressure from baseline to endpoint, Baseline, Week 52
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| Locations: |
Research Site, Mesa, Arizona, United States|Research Site, Tempe, Arizona, United States|Research Site, Concord, California, United States|Research Site, Fresno, California, United States|Research Site, La Mesa, California, United States|Research Site, Atlanta, Georgia, United States|Research Site, Idaho Falls, Idaho, United States|Research Site, Bowling Green, Kentucky, United States|Research Site, Corvallis, Oregon, United States|Research Site, Chattanooga, Tennessee, United States|Research Site, Memphis, Tennessee, United States|Research Site, New Westminister, British Columbia, Canada|Research Site, Ajax, Ontario, Canada|Research Site, Cambridge, Ontario, Canada|Research Site, Windsor, Ontario, Canada|Research Site, Chihuahua, Chiuahua, Mexico|Research Site, Monterrey, Nuevo Leon, Mexico|Research Site, Distrito Federal, Mexico|Research Site, Baia Mare, Romania|Research Site, Brasov, Romania|Research Site, Bucharesti, Romania|Research Site, Craiova, Romania|Research Site, Iasi, Romania|Research Site, Suceava, Romania|Research Site, Johannesburg, South Africa|Research Site, Pretoria, South Africa
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