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TITLE:

CLINICAL TRIAL TO EXAMINE EFFECTS OF DAPAGLIFLOZIN ON HIGH DOSE INSULIN RECEIVING PATIENTS OF TYPE 2 DIABETES

AUTHORS:

Dr Irum Arshad, Dr Muhammad Uzair, Dr Rubab Arif

ABSTRACT:

Abstract: Aim of study: We held this study to examine the safety and efficiency of dapagliflozin in those patients of diabetes who are already using high dose of insulin. Study design: Clinical trials. Study place and duration: This study was conducted in Holy Family Hospital, Rawalpindi for the duration of on year starting from March, 2018 to February, 2019. Methodology: We included a total number of 30 patients of diabetes who were using oral antidiabetic other than SGLT 2 inhibitors and getting insulin more than 0.5 U/Kg. Observing the doses of insulin, variations of serum electrolyte and HbA1C levels with additional treatment of dapagliflozin (10mg) for the duration of 03 months was the primary end point of our study. Results: After the 03 months treatment with dapagliflozin (10mg) we observed reduction in BMI from 33.31 ± 4.51 to 32.14 ± 4.66 with the P-value of 0.001. We also noted the reduction in the requirement of insulin from 76 ± 23.15 U/kg to 57.60 ± 17.61 U/kg per day with the P-value more than 0.001. On the other hand, we also observed the decrease in HbA1C level as Δ1.6% and reduction in level of fasting plasma glucose as Δ68.6mg/dl with P-value less than 0.001. A little bit significant increase was observed in sodium levels and blood urea nitrogen (BUN) during the assessment of serum electrolyte levels with P-values as 0.044 and 0.026 respectively. No significant changes were observed in electrolytes like vitamin D, phosphorus magnesium, calcium and potassium while examining the serum cholesterol levels and P-value was found more than 0.05. Conclusion: At the end of the study we concluded that to get optimal levels of BMI, HbA1C and fasting plasma glucose with minimum side effects, dapagliflozin might be another choice of combination to reduce the need of insulin in the patients of diabetes who are already using high dose of insulin to control their inadequate sugar levels. Key Words: High dose insulin, Dapagliflozin, Efficacy, HbA1C, fasting plasma glucose.

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