| خلاصه مقاله | Objective: The objective of the study was evaluating the application of Empagliflozin as adjunctive to insulin in patients with type 1 diabetes.
Methods: In this Double-blind placebo-controlled randomized clinical trial, 60 Type 1 diabetic patients were randomly allocated to receive once-daily empagliflozin 10 mg or placebo as an adjunct to insulin for 12 weeks. The primary objective was to assess the effect of empagliflozin on glycemic control and insulin doses.
Results: Empagliflozin, s mean placebo-subtracted glycated hemoglobin A1C(Hb A1C) reduction was -0.18 ( 95% CI: -0.37, 0.005, P=0.009), Fasting blood sugar (FBS) –2.60 mg/dl (95% CI: -6.48, 1.28, P=0.035), 2-hour post-prandial blood sugar (BS 2hpp) -22.56 mg/dl (95% CI: -35.15, 8.97, P<0.0001) and Total daily insulin dose –7.6 units (95% CI: -12.4, 2.8, P=0.003). Furthermore, Empagliflozin 10 mg reduced Body Mass Index(BMI)by -0.560 kg (95% CI: -0.640,1.46, P<0.0001). In this study, empagliflozin was well tolerated, hypoglycemia, genital and urinary infections, and diabetic ketoacidosis events were not reported.
Conclusion: The present study indicated that Empagliflozin is effective as an adjunct therapy to insulin in T1DM, improved glycemic control, reduced BMI, and total daily insulin dose without hypoglycemia, diabetic ketoacidosis, or genital and urinary infections. |