Primary Objective: \>To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c \<= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: * Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. * Incidence of confirmed symptomatic and nocturnal hypoglycemia. * Incidence of confirmed severe hypoglycemia (\< 36mg/dL or need of help to recover). \>Weight variation for each period of treatment. * Creatinine clearance at baseline and after each period of treatment. * Overall safety: Incidence of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Investigational Site Number 076-007
Curitiba, Brazil
Investigational Site Number 076-010
Fortaleza, Brazil
Investigational Site Number 076-001
Fortaleza, Brazil
Investigational Site Number 076-003
Porto Alegre, Brazil
Investigational Site Number 076-005
São Paulo, Brazil
Investigational Site Number 076-013
São Paulo, Brazil
Investigational Site Number 076-004
São Paulo, Brazil
Investigational Site Number 076-002
São Paulo, Brazil
Investigational Site Number 076-009
São Paulo, Brazil
Investigational Site Number 076-006
Taguatinga, Brazil
Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.
Time frame: From visit 1 (Day 1) to visit 13 (Day 169)
Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL).
Time frame: From baseline and Visit 13 (Day 169)
Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.
Time frame: 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
Time frame: From baseline and Visit 13 (Day 169)
Weight variation
Time frame: From baseline to the end of treatment at visit 13 (day 169)
Creatinine clearance variation
Time frame: From baseline to the end of treatment at visit 13 (day 169)
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