This is a multicenter, randomised, open-label, crossover, 2-period comparative phase IV study. The primary objective is to compare the effect of dapagliflozin 10 mg once daily in combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life and treatment satisfaction in patients with type 2 diabetes.
The study will comprise the following phases: Screening, Treatment Period 1 and Treatment Period 2. After screening examinations and assessments, all patients enrolled will be randomly assigned in equal proportion (1:1) to either study arm: Arm 1: * Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks during Treatment Period 1 * Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks during Treatment Period 2 Arm 2 (the same treatment phases in reverse order): * Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks during Treatment Period 1 * Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks during Treatment Period 2 Following the randomisation procedure, patients will receive investigational products at each visit as scheduled by Treatment Period 1. After the Randomisation Visit (Visit 2), the patient should attend the study centre for Visits 3, 4, and 5 (Day 28, Day 86, and Day 168, respectively) for efficacy and safety assessments. At Visit 5 (Day 168), the patient will receive investigational products as required by Treatment Period 2. Further Visits 6, 7 and 8 will be scheduled on Day 196, Day 252, Day 336, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Dapagliflozin, 10 mg
Metformin, up to 2500 mg
Composite endpoint including quality of life score
Change in the overall quality of life, obesity-specific quality of life and treatment satisfaction in the course of the therapy by the end of each 24-week treatment period compared to the quality of life, obesity-specific quality of life and treatment satisfaction at baseline.
Time frame: 48 weeks
Change in HbA1c level
Change in HbA1c level will be assessed as mean change in the course of the treatment compared to baseline.
Time frame: 48 weeks
Change in body weight
Change in body weight will be assessed as mean change in body weight, mean percentage change in body weight and mean change in body mass index compared to baseline and as proportion of patients with body weight decreased by ≥5% during the treatment phase.
Time frame: 48 weeks
Change in waist circumference
Change in waist circumference will be assessed as mean change and mean percentage change in waist circumference during the treatment phase compared to baseline.
Time frame: 48 weeks
Change in fasting plasma glucose
Change in fasting plasma glucose will be assessed as mean change in fasting plasma glucose during the treatment phase compared to baseline.
Time frame: 48 weeks
Proportion of patients
Proportion of patients who achieved therapeutic glycaemic response (HbA1c ≤7%).
Time frame: 48 weeks
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