The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trial
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 mel...
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Tabriz University of Medical Sciences
2024-12-01
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| Series: | Health Promotion Perspectives |
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| Online Access: | https://hpp.tbzmed.ac.ir/PDF/hpp-14-380.pdf |
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| author | Mostafa Najafipour Farzad Najafipour Alireza Ostadrahimi Maryam Ghavami Zohreh Razaghi Helda Tutunchi Naimeh Mesri Alamdari |
| author_facet | Mostafa Najafipour Farzad Najafipour Alireza Ostadrahimi Maryam Ghavami Zohreh Razaghi Helda Tutunchi Naimeh Mesri Alamdari |
| author_sort | Mostafa Najafipour |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-1e8bce32e84c46b49f0f3110e66bd9d3 |
| institution | OA Journals |
| issn | 2228-6497 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Tabriz University of Medical Sciences |
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| series | Health Promotion Perspectives |
| spelling | doaj-art-1e8bce32e84c46b49f0f3110e66bd9d32025-08-20T02:16:55ZengTabriz University of Medical SciencesHealth Promotion Perspectives2228-64972024-12-0114438038710.34172/hpp.42486hpp-42486The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trialMostafa Najafipour0Farzad Najafipour1Alireza Ostadrahimi2Maryam Ghavami3Zohreh Razaghi4Helda Tutunchi5Naimeh Mesri Alamdari6Department of Internal Medicine, Faculty of Medicine, Azad Ardabil University of Medical Sciences, Ardabil, IranEndocrine Research Center, Tabriz University of Medical Sciences, Tabriz, IranNutrition Research Center, Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, IranDepartment of Internal Medicine, Faculty of Medicine, Azad Ardabil University of Medical Sciences, Ardabil, IranEndocrine Research Center, Tabriz University of Medical Sciences, Tabriz, IranEndocrine Research Center, Tabriz University of Medical Sciences, Tabriz, IranEndocrine Research Center, Tabriz University of Medical Sciences, Tabriz, IranBackground: 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).https://hpp.tbzmed.ac.ir/PDF/hpp-14-380.pdfempagliflozinsodium-glucose transporter 2 inhibitorstype 1 diabetes |
| spellingShingle | Mostafa Najafipour Farzad Najafipour Alireza Ostadrahimi Maryam Ghavami Zohreh Razaghi Helda Tutunchi Naimeh Mesri Alamdari The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trial Health Promotion Perspectives empagliflozin sodium-glucose transporter 2 inhibitors type 1 diabetes |
| title | The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trial |
| title_full | The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trial |
| title_fullStr | The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trial |
| title_full_unstemmed | The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trial |
| title_short | The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trial |
| title_sort | effects of empagliflozin in patients with type 1 diabetes results of a 12 week double blind randomized placebo controlled clinical trial |
| topic | empagliflozin sodium-glucose transporter 2 inhibitors type 1 diabetes |
| url | https://hpp.tbzmed.ac.ir/PDF/hpp-14-380.pdf |
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