| Outcome Measures: |
Primary: Change in HbA1c (Percent), Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values \[X% - Y%\], Baseline to 20 Weeks | Secondary: Percentage of Patients Achieving HbA1c <=7.0%, Percentage of patients whose baseline HbA1c was \> 7.0% achieving HbA1c \<=7.0% at endpoint (Week 20), Baseline to 20 Weeks|Percentage of Patients Achieving HbA1c <7.0%, Percentage of patients whose baseline HbA1c was \>=7.0% achieving HbA1c \<7.0% at endpoint (Week 20), Baseline to 20 Weeks|Percentage of Patients Achieving HbA1c <=6.5%, Percentage of patients whose baseline HbA1c was \> 6.5% achieving HbA1c \<=6.5% at endpoint (Week 20), Baseline to 20 Weeks|Change in FSG (mmol/L), Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20), Baseline to 20 Weeks|Change in Body Weight (kg), Change in body weight from baseline to endpoint (Week 20), Baseline to 20 Weeks|Change in Waist Circumference (cm), Change in waist circumference from baseline to endpoint (Week 20), Baseline to 20 Weeks|Waist-to-Hip Ratio, Change in waist-to-hip ratio from baseline to endpoint (Week20), Baseline to 20 Weeks|SMBG (mmol/L), 7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20), Baseline to 20 Weeks|Change in Triglycerides (mmol/L), Change in triglycerides from baseline to endpoint (Week 20), Baseline to 20 Weeks|Change in HDL (mmol/L), Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20), Baseline to 20 Weeks|Change in LDL (mmol/L), Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20), Baseline to 20 Weeks|Change in Total Cholesterol (mmol/L), Change in total cholesterol from baseline to endpoint (Week 20), Baseline to 20 Weeks|Incidence of Hypoglycemia (Overall), Incidence of hypoglycemic episodes experienced overall during the study, Baseline to 20 Weeks|Incidence of Severe Hypoglycemia(Overall), Incidence of severe hypoglycemia experienced overall during the study, Baseline to 20 Weeks|Incidence of Nocturnal Hypoglycemia (Overall), Incidence of nocturnal hypoglycemia experienced overall during the study, Baseline to 20 Weeks|Incidence of Confirmed Hypoglycemia(Overall), Incidence of confirmed hypoglycemia experienced overall during the study, Baseline to 20 Weeks
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| Locations: |
Research Site, Buenos Aires, Argentina|Research Site, Morón, Argentina|Research Site, Adelaide, Australia|Research Site, Geelong, Australia|Research Site, Melbourne, Australia|Research Site, Aschaffenburg, Germany|Research Site, Asslar, Germany|Research Site, Beckum-Neubeckum, Germany|Research Site, Berlin, Germany|Research Site, Bosenheim, Germany|Research Site, Essen, Germany|Research Site, Falkensee, Germany|Research Site, Furth im Wald, Germany|Research Site, Grevenbroich, Germany|Research Site, Hamburg-Othmarschen, Germany|Research Site, Hohenmolsen, Germany|Research Site, Leipzig, Germany|Research Site, Neuwied, Germany|Research Site, Pohlheim, Germany|Research Site, Speyer, Germany|Research Site, Athens, Greece|Research Site, Thessaloniki, Greece|Research Site, Ahmedabad, India|Research Site, Bangalore, India|Research Site, Coimbatore, India|Research Site, Indore, India|Research Site, Jaipur, India|Research Site, Daegu, Korea, Republic of|Research Site, Gwangju, Korea, Republic of|Research Site, Seoul, Korea, Republic of|Research Site, Ulsan, Korea, Republic of|Research Site, Coatzacoalcos, Mexico|Research Site, Guadalajara, Mexico|Research Site, Merida, Mexico|Research Site, Monterrey, Mexico|Research Site, Tampico, Mexico
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