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

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.
 How to cite this:Sertbas M, Sertbas Y, Okuroglu N, Akyildiz AB, Sancak S, Ozdemir A. Effıcacy and safety of dapagliflozin on diabetic patients receiving high-doses of insulin. Pak J Med Sci. 2019;35(2):---------. doi: https://doi.org/10.12669/pjms.35.2.21
 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Clinical outcomes of Sodium-glucose cotransporter-2 inhibitors in patients with Type 2 Diabetes Mellitus: An observational study from Pakistan

“…This single-center 6 months study from Pakistan shows SGLT2 inhibitors are effective in the Pakistani population not only in glycemic control but also in the weight reduction and other metabolic effects with fewer side effects. Our study results further strengthens the outcome data from the previous studies, 7 , 8 , 16 mostly done in the developed countries, by showing significant improvement in different metabolic parameters in the diverse population with T2DM in the real-world setting in Pakistan.…”

“…the weight reduction and other metabolic effects with fewer side effects. Our study results further strengthens the outcome data from the previous studies, 7,8,16 mostly done in the developed countries, by showing significant improvement in different metabolic parameters in the diverse population with T2DM in the real-world setting in Pakistan. Reduction in the HbA1c observed in this study, from 8.7 ± 1.5% to 7.9 ± 1.2% at 3 months and further reduction to 7.5 ± 1.1 at 6 months is comparable to the results of other real world studies and trials in which agents of this group were either used in combination or as monotherapy and showed improvement in HbA1c up to 1.8%.…”

“…21 A decrease in the BMI noted in our study is also comparable to other studies. 16,18 We found a decrease in BMI from 32.4 ±5.9 kg/m 2 to 31.8±5.8 kg/m 2 and 31.4±5.8 kg/m 2 at 3 and 6 months respectively. Weight reduction associated with SGLT2i likely observed is mainly because of their glycosuria induced energy loss and reduction in the fat mass was found to be sustained for more than two years of treatment as reported by Bolinder J et al 22 Because of this weight reduction and improvement in BMI one can expect a decrease in daily dose requirement of insulin and SU as seen in this study and other clinical studies on this drug group.…”

“…Reduction in the HbA1c observed in this study, from 8.7 ± 1.5% to 7.9 ± 1.2% at 3 months and further reduction to 7.5 ± 1.1 at 6 months is comparable to the results of other real world studies and trials in which agents of this group were either used in combination or as monotherapy and showed improvement in HbA1c up to 1.8%. [13][14][15][16][17][18] This reduction in HbA1c and improvement in insulin sensitivity and decrease in insulin resistance along with a reduction in the beta-cell loss as reported by Merocvi A, et al 19 make SGLT2i as a potent agent to be used in combination or as monotherapy as supported by EASD-ADA position statement for DM management. 20 Most patients with T2DM are obese or overweight and weight loss in a diabetic patient is among the desired outcome because of its impact on insulin sensitivity, overall glycemic control, and long-term morbidities.…”

SGLT 2 Inhibitors; glycemic control, weight loss and safety profile in patients with type 2 Diabetes, at Medicell Institute (MIDEM)

“… 22 In a small study of Dapagliflozin in Turkish patients, HbA1c improved 1.6% with significant weight reduction and decrease in insulin dose. 23 A recent publication on use of Dapagliflozin in Pakistan, reported mean HbA1c and weight reduction of -1.1% and -1.98 kg, respectively. 24 Our study results are comparable to above studies with mean HbA1c reduction of 1.34% and mean weight reduction of 2.3 kg.…”