| Outcome Measures: |
Primary: Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%., From visit 1 (Day 1) to visit 13 (Day 169) | Secondary: Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL)., From baseline and Visit 13 (Day 169)|Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL., From baseline and Visit 13 (Day 169)|Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, From baseline and Visit 13 (Day 169)|Weight variation, From baseline to the end of treatment at visit 13 (day 169)|Creatinine clearance variation, From baseline to the end of treatment at visit 13 (day 169)
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| Locations: |
Investigational Site Number 076-007, Curitiba, 80060-900, Brazil|Investigational Site Number 076-010, Fortaleza, 60015-052, Brazil|Investigational Site Number 076-001, Fortaleza, 60115-282, Brazil|Investigational Site Number 076-003, Porto Alegre, 91350-250, Brazil|Investigational Site Number 076-005, São Paulo, 01244-030, Brazil|Investigational Site Number 076-013, São Paulo, 01308-050, Brazil|Investigational Site Number 076-004, São Paulo, 01323-001, Brazil|Investigational Site Number 076-002, São Paulo, 04024-002, Brazil|Investigational Site Number 076-009, São Paulo, o4039-000, Brazil|Investigational Site Number 076-006, Taguatinga, 72155000, Brazil
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