| Outcome Measures: |
Primary: Change in glycated hemoglobin (HbA1c)%, Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit), Baseline to Week 26 | Secondary: Percentage of patients achieving HbA1c ≤7% at Week 26, Percentage of patients achieving A1c ≤7%, At Week 26|Change in fasting plasma glucose (FPG) from baseline to Week 12, Change in FPG from baseline to Week 12, Baseline to Week 12|Change in FPG from baseline to Week 26, Change in FPG from baseline to Week 26, Baseline to Week 26|Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12, Change in fasting SMPG from baseline to Week 12, Baseline to Week 12|Change in fasting SMPG from baseline to Week 26, Change in fasting SMPG from baseline to Week 26, Baseline to Week 26|Change in 7-point SMPG profile from baseline to Week 12, Change in 7-point SMPG profile from baseline to Week 12, Baseline to Week 12|Change in 7-point SMPG profile from baseline to Week 26, Change in 7-point SMPG profile from baseline to Week 26, Baseline to Week 26|Change in body weight from baseline to Week 26, Change in body weight (kg), Baseline to Week 26|Percentage of patients achieving A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L) at Week 26, Composite endpoint expressed as percentage of patients A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L), Baseline to Week 26|Insulin glargine dose, Insulin glargine dose (expressed in units), At Week 26|Percentage of patients requiring rescue therapy, Percentage of patients requiring rescue therapy during the 26-week open-label treatment period, Baseline to Week 26|Percentage of patients experiencing at least 1 hypoglycemia episode (≤3.9 mmol/L) over 26 weeks, Percentage of patients experiencing at least 1 hypoglycemia episode defined as ≤3.9 mmol/L, Baseline to Week 26|Percentage of patients experiencing at least 1 hypoglycemia episode (<3.0 mmol/L) over 26 weeks, Percentage of patients experiencing at least 1 hypoglycemia episode defined as \<3.0 mmol/L, Baseline to Week 26|Annualized rate of hypoglycemia (≤3.9 mmol/L) over 26 weeks, Mean number of hypoglycemia episodes (≤3.9 mmol/L) per patient year of exposure over 1 year, Baseline to Week 26|Annualized rate of hypoglycemia (<3.0 mmol/L) over 26 weeks, Mean number of hypoglycemia episodes (\<3.0 mmol/L) per patient year of exposure over 1 year, Baseline to Week 26
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| Locations: |
Investigational Site Number 1240004, Barrie, L4N4L3, Canada|Investigational Site Number 1240006, Brampton, L6S0C9, Canada|Investigational Site Number 1240002, Brampton, L6T4V3, Canada|Investigational Site Number 1240005, Burlington, L7R1A4, Canada|Investigational Site Number 1240003, Calgary, T2H2G4, Canada|Investigational Site Number 1240024, Chicoutimi, G7H7K9, Canada|Investigational Site Number 1240014, Concord, L4K4M2, Canada|Investigational Site Number 1240017, Etobicoke, M9R4E1, Canada|Investigational Site Number 1240030, Greenfield Park, J4V2G8, Canada|Investigational Site Number 1240031, Halifax, B3H1V7, Canada|Investigational Site Number 1240026, Hamilton, L8S4K1, Canada|Investigational Site Number 1240011, Laval, H7T 2P5, Canada|Investigational Site Number 1240016, London, N6A 4V2, Canada|Investigational Site Number 1240015, London, N6G 4X8, Canada|Investigational Site Number 1240019, Mirabel, J7J2K8, Canada|Investigational Site Number 1240018, Montreal, H1M1B1, Canada|Investigational Site Number 1240023, Montreal, H4A2C6, Canada|Investigational Site Number 1240020, Montreal, H4A3T2, Canada|Investigational Site Number 1240029, Montreal, H4T1Z9, Canada|Investigational Site Number 1240027, Nepan, K2J0V2, Canada|Investigational Site Number 1240025, Newmarket, Canada|Investigational Site Number 1240021, Oakville, L6M1M1, Canada|Investigational Site Number 1240009, Oshawa, L1H7K4, Canada|Investigational Site Number 1240008, Quebec, G1G3Y8, Canada|Investigational Site Number 1240022, Quebec, G1V4W2, Canada|Investigational Site Number 1240028, Saint-Lambert, J4P2H4, Canada|Investigational Site Number 1240013, St-Marc-des-Carrieres, Canada|Investigational Site Number 1240033, Toronto, M3J0K2, Canada|Investigational Site Number 1240001, Toronto, M4G3E8, Canada|Investigational Site Number 1240012, Vancouver, V5Y3W2, Canada|Investigational Site Number 1240007, Victoriaville, G6P6P6, Canada|Investigational Site Number 1240032, Winnipeg, R2V4W3, Canada
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