Outcome Measures: |
Primary: Percentage of patients with at least one episode of hypoglycemia, 16 weeks | Secondary: Percentage of patients achieving HbA1c <7%, 16 weeks|Percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L), 16 weeks|Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L), 16 weeks|Change from baseline in HbA1c, Baseline, 16 weeks|Change from baseline in Fasting Plasma Glucose, Baseline, 16 weeks|Change from baseline in Post Prandial Glucose, Baseline, 16 weeks|Change in body weight, Baseline, 16 weeks|- Change in insulin dose, Baseline, 16 weeks|Number of overall hypoglycemic events (with severe or confirmed hypoglycemia [≤3.9 mmol/L]), Baseline, 16 weeks|Number of nocturnal hypoglycemic events, Baseline, 16 weeks|Number of severe hypoglycemic events, Baseline, 16 weeks
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