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Purpose: To investigate the clinical effectiveness of combination of metformin and ipragliflozin in the treatment of patients with type-2 diabetes mellitus (T2DM).
Methods: Patients with T2DM (n = 100) aged 35 – 68 years (mean age = 51.5 ± 16.5 years) were recruited over a 1-year period and randomly assigned to 2 groups (50 patients/group): control and study groups. Control group patients were treated with metformin orally at a dose of 500 mg/kg body weight twice a day, while patients in the study group received 50 mg ipragliflozin/kg, orally once a day, in addition to metformin. Fasting blood glucose (FBG), 2-h postprandial blood glucose (PBG), bedtime glucose (BBG) and glycated hemoglobin (HbAlc) concentrations were measured in patients’ plasma before and after treatment. Incidence of adverse reactions, changes in body fat and clinical effectiveness were also determined.
Results: FBG, 2-h PBG, BBG, HbAlc, body fat and incidence of adverse reactions were markedly reduced in T2DM patients treated with the combination of metformin and ipragliflozin, relative to those treated with metformin alone (p < 0.05). After treatment, the proportion of outcomes categorized as ‘markedly effective’ and ‘total effectiveness’ was higher in the study group than in the control group (p < 0.05).
Conclusion: The combination of metformin and ipragliflozin is safer and more clinically effective in the treatment of T2DM than metformin monotherapy.
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