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OBJECTIVE: This study aims to evaluate the efficacy and safety of the addition of 10 or 25 mg of empagliflozin to patients with type 2 diabetes mellitus using a maximum tolerable dose of metformin and gliclazide. METHODS: A total of 60 patients who had been receiving a maximum tolerable dose of metformin plus gliclazide. was divided into two groups in this study. In the first group (Group 1, n=32), 10 mg empagliflozin was added to the current treatment once a day, and in the second group (Group 2, n=28) 25 mg empagliflozin was added to the same treatment once a day. Biochemical results, weight and blood pressure changes of the patients in both groups were evaluated before and after 12 weeks of empagliflozin addition. Patients who developed urinary tract and genital infections after treatment were recorded. RESULTS: There was a statistically significant decrease in HbA1c in both groups after empagliflozin treatment (Group 1, p<0.001 and Group2, p=0.001). When the lipid profile was evaluated, no significant difference was found between basal and post-treatment parameters (p>0.05). Patients in Group 1 and Group 2 lost 2.6±1.2 and 3.8±2.0 kg of body weight, respectively (p<0.0001 for each). There were also significant reductions in systolic and diastolic blood pressure for groups 1 and 2 (p<0.0001 for each). Although there was a numerical increase in the urinary tract and genital infections in both groups after empagliflozin treatment, there was no statistically significant difference compared to the pre-treatment period (p>0.05). CONCLUSION: Two doses of empagliflozin added to the present treatments showed a dose-independent improvement in glycemic control and a neutral effect on lipid metabolism.

The effect of low and high dose empagliflozin on HbA1c and lipid profile in Type 2 Diabetes mellitus: A real world data