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Health Promot Perspect. 2024;14(4): 380-387.
doi: 10.34172/hpp.42486
  Abstract View: 8
  PDF Download: 12

Original Article

The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trial

Mostafa Najafipour 1 ORCID logo, Farzad Najafipour 2* ORCID logo, Alireza Ostadrahimi 3, Maryam Ghavami 1, Zohreh Razaghi 2, Helda Tutunchi 2, Naimeh Mesri Alamdari 2* ORCID logo

1 Department of Internal Medicine, Faculty of Medicine, Azad Ardabil University of Medical Sciences, Ardabil, Iran
2 Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
3 Nutrition Research Center, Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran
*Corresponding Authors: Farzad Najafipour, Email: farzadnajafipour@gmail.com; Naimeh Mesri Alamdari, Email: mesri65@gmail.com

Abstract

Background: Sodium-glucose cotransporter-2 (SGLT-2) acts as a key element in the reabsorption of glucose in the kidney. Currently, SGLT-2 inhibitors are FDA-approved for the treatment of type 2 diabetes. It is suggested that the mechanism of action may operate in the treatment of type 1 diabetes mellitus (T1DM), as well. This study aimed to evaluate the application of empagliflozin as an adjunctive to insulin in patients with T1D.

Methods: In this double-blind placebo-controlled randomized clinical study, 60 type 1 diabetic patients were randomly assigned to have either once-daily empagliflozin 10 mg or placebo, as an addition to insulin for 12 weeks. The hemoglobin A1C, fasting blood sugar (FBS), 2-hour post-prandial blood sugar, and anthropometric indices were measured before and after 12 weeks intervention.

Results: After 12 weeks, empagliflozin resulted in significant reductions of hemoglobin A1C -0.18 (95% CI: -0.37, 0.005, P=0.009), FBS –2.60 mg/dL (95% CI: -6.48, 1.28, P=0.035), 2-hour post-prandial blood sugar -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 reduced body mass index (BMI) by -0.560 kg (95% CI: -0.640, 1.46, P<0.0001). Empagliflozin was well tolerated in the patients. Also, no case of hypoglycemia, genital and urinary infections, or diabetic ketoacidosis (DKA) was reported.

Conclusion: The present study supported the use of empagliflozin alongside insulin as a treatment option for individuals with T1D.

Trial Registration: http:// www.irct.ir, identifier: irct20130610013612N12, Registration date: 12/9/2022).


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Submitted: 04 Sep 2024
Accepted: 08 Nov 2024
ePublished: 30 Dec 2024
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