Effıcacy and safety of dapagliflozin on diabetic patients receiving high-doses of insulin

OBJECTIVE: In this study we aimed to investigate the efficacy and safety of dapagliflozin addition to diabetic patients using high dose insulin. METHODS: The current study was carried out in the outpatient diabetic clinics of Fatih Sultan Mehmet Education and Research Hospital. Thirty diabetic patients who were receiving high dose (>0,5U/kg) insulin and oral antidiabetic treatment (other than SGLT 2 inhibitors) were included in this study. Primary end point was the change in HbA1c, insulin doses and serum electrolyte from the addition of dapagliflozin 10 mg to the week 12. RESULTS: At the end of three month BMI were obviously decreased from 33.31 ±4.51 to 32.14 ±4.66 (p: 0.001). There was also an evident decrease of insulin requirement from 76 ±23.15 U/kg to 57.60 ±17.61 U/day (p<0.001). As well as the decrease in insulin doses, there was also a significant decline in HbA1c (Δ 1.6 %) and fasting blood glucose levels (Δ68.6 mg/dl) (p<0.001). Among serum electrolyte levels slight but meaningful increase of blood urea nitrogen (BUN) and sodium (Na) levels were seen (p: 0.044 and p: 0.026). There were no significant changes in serum cholesterol levels with electrolytes such as potassium, calcium, phosphorus magnesium and vitamin D (p> 0.05). CONCLUSION: In diabetic patients with inadequately controlled glucose regulation despite high-dose insulin therapy, dapagliflozin may be an alternative combination choice to decrease the need of insulin dose and obtain an optimal HbA1c, fasting plasma glucose levels and weight without major side effects.