Abstract
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.
Highlights
International Diabetes Federation (IDF) diabetes Atlas had estimated that in 2017 there were 451 million people with diabetes worldwide and expected to increase to 693 million by 2045.1 Diabetes mellitus is a chronic metabolic disease that requires lifelong follow-up and treatment, characterized by absolute or partial loss of insulin secretion or decrease of the peripheral effect of insulin
A few studies have been performed in this area, when we search for clinical trials in PubMed, no one have been investigated the effects of dapagliflozin on serum electrolytes and the insulin dose reduction on high-dose insulin using patients in the Turkish population
Patients having a history of Type-1 diabetes mellitus, cardiovascular events, breast feeding and pregnancy were excluded from the study
Summary
International Diabetes Federation (IDF) diabetes Atlas had estimated that in 2017 there were 451 million people with diabetes worldwide and expected to increase to 693 million by 2045.1 Diabetes mellitus is a chronic metabolic disease that requires lifelong follow-up and treatment, characterized by absolute or partial loss of insulin secretion or decrease of the peripheral effect of insulin. It has been associated with the development of both macrovascular and microvascular complications with the increase of morbidity and mortality.[2] Less than 50% of the patients achieve glycemic targets with the oral antihyperglycemic agents and most of the patients require insulin therapy.[3]. A few studies have been performed in this area, when we search for clinical trials in PubMed (from inception through June 2016), no one have been investigated the effects of dapagliflozin on serum electrolytes and the insulin dose reduction on high-dose insulin using patients in the Turkish population
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