| Outcome Measures: |
Primary: Change in Glycosylated Hemoglobin (HbA1c), Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0), Baseline and 26 weeks|Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode), Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26, 26 weeks | Secondary: Percentage of Subjects Achieving HbA1c Target of < 6.5%, Percentage of subjects achieving HbA1c target of \< 6.5% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 6.5% divided by total number of subjects times 100%\]., 26 weeks|Percentage of Subjects Achieving HbA1c Target of < 7.0%, Percentage of subjects achieving HbA1c target of \< 7.0% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 7.0% divided by total number of subjects times 100%\]., 26 weeks|Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period), Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)\[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%\], 26 weeks|Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period), Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) \[i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%\]., 26 weeks|7 Point Self-monitored Blood Glucose (SMBG) Profiles, 7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am)., Baseline and 26 weeks|Blood Lipid Levels, Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26), Baseline and 26 weeks|Change in Body Weight, Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0), Baseline and 26 weeks|Change in Body Mass Index (BMI), Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0), Baseline and 26 weeks|Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ), Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction., Baseline and 26 weeks|Patient Reported Outcomes: Quality of Life (SF-12), SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores \> 50 indicate an above-average health status., Baseline and 26 weeks
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| Locations: |
Research Site, Bad Mergentheim, Germany|Research Site, Berlin, Germany|Research Site, Bosenheim, Germany|Research Site, Burghausen, Germany|Research Site, Datteln, Germany|Research Site, Dresden, Germany|Research Site, Essen, Germany|Research Site, Friedrichsthal, Germany|Research Site, Hildesheim, Germany|Research Site, Hirschhorn, Germany|Research Site, Hohenmolsen, Germany|Research Site, Jena, Germany|Research Site, Lehrte, Germany|Research Site, Leipzig, Germany|Research Site, Ludwigsburg, Germany|Research Site, Mannheim, Germany|Research Site, Marburg, Germany|Research Site, Marktheidenfeld, Germany|Research Site, Meissen, Germany|Research Site, Munchen, Germany|Research Site, Offenbach, Germany|Research Site, Oschatz, Germany|Research Site, Pohlheim, Germany|Research Site, Regensburg, Germany|Research Site, Riesa, Germany|Research Site, Rodgau, Germany|Research Site, Roding, Germany|Research Site, Rosenheim, Germany|Research Site, Schluchtern, Germany|Research Site, Schwedt/Oder, Germany|Research Site, Sinsheim, Germany|Research Site, Speyer, Germany|Research Site, Unterhaching, Germany|Research Site, Volklingen, Germany|Research Site, Wallerfing, Germany|Research Site, Wangen, Germany|Research Site, Warburg, Germany|Research Site, Wiesbaden, Germany|Research Site, Wolfsburg, Germany
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