A pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetes
Introduction: Sodium-glucose linked transporter (SGLT) inhibitors could improve glycaemia and simplify insulin regimens in recent-onset type 1 diabetes (T1D), provided they were well-tolerated and safe. This study aimed to determine the feasibility and safety of a SGLT inhibitor for the treatment of...
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2020-03-01
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doaj-1bbacb65c9fe4f29944b4cddfa362b642020-11-25T02:52:32ZengElsevierMetabolism Open2589-93682020-03-015A pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetesJohn M. Wentworth0Spiros Fourlanos1Peter G. Colman2Leonard C. Harrison3Royal Melbourne Hospital, Department of Diabetes and Endocrinology, Australia; Royal Melbourne Hospital Department of Medicine, University of Melbourne, Australia; Walter and Eliza Hall Institute of Medical Research, Population Health and Immunity Division, Australia; Corresponding author. Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville 3050, Australia.Royal Melbourne Hospital, Department of Diabetes and Endocrinology, Australia; Royal Melbourne Hospital Department of Medicine, University of Melbourne, AustraliaRoyal Melbourne Hospital, Department of Diabetes and Endocrinology, Australia; Royal Melbourne Hospital Department of Medicine, University of Melbourne, AustraliaRoyal Melbourne Hospital Department of Medicine, University of Melbourne, Australia; Walter and Eliza Hall Institute of Medical Research, Population Health and Immunity Division, AustraliaIntroduction: Sodium-glucose linked transporter (SGLT) inhibitors could improve glycaemia and simplify insulin regimens in recent-onset type 1 diabetes (T1D), provided they were well-tolerated and safe. This study aimed to determine the feasibility and safety of a SGLT inhibitor for the treatment of recent-onset T1D. Method: An open label, prospective pilot study in adults with recent-onset T1D was performed. Empagliflozin, 25 mg orally daily, was given in combination with insulin and multidisciplinary care during a 24-week treatment phase, followed by wash-out visits at weeks 30 and 36. Results: Fourteen participants (4 women; median age 26 years) began and 13 completed the study. No treatment-emergent serious adverse events were observed, with fatigue and genital infection the most common side-effects. Four participants stopped mealtime insulin for at least one month when taking empagliflozin. At week 24, median weight, HbA1c and insulin dose decreased by 4.4 kg, 1.5% (17 mmol/mol) and 0.03 units/kg/day, respectively. Meal-stimulated C-peptide was maintained during the treatment phase and then decreased at 36 weeks. Conclusions: Treatment of adults with empagliflozin within 100 days of T1D diagnosis appeared safe and was associated with improved clinical outcomes. These findings justify a definitive trial to determine if SGLT inhibitors simplify treatment regimens and improve clinical outcomes in recent-onset T1D. Registration: ACTRN12617000016336. Keywords: Type 1 diabetes, SGLT-2 inhibitor, Clinical trial, Beta-cell function, Feasibility studyhttp://www.sciencedirect.com/science/article/pii/S2589936820300013 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
John M. Wentworth Spiros Fourlanos Peter G. Colman Leonard C. Harrison |
spellingShingle |
John M. Wentworth Spiros Fourlanos Peter G. Colman Leonard C. Harrison A pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetes Metabolism Open |
author_facet |
John M. Wentworth Spiros Fourlanos Peter G. Colman Leonard C. Harrison |
author_sort |
John M. Wentworth |
title |
A pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetes |
title_short |
A pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetes |
title_full |
A pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetes |
title_fullStr |
A pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetes |
title_full_unstemmed |
A pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetes |
title_sort |
pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetes |
publisher |
Elsevier |
series |
Metabolism Open |
issn |
2589-9368 |
publishDate |
2020-03-01 |
description |
Introduction: Sodium-glucose linked transporter (SGLT) inhibitors could improve glycaemia and simplify insulin regimens in recent-onset type 1 diabetes (T1D), provided they were well-tolerated and safe. This study aimed to determine the feasibility and safety of a SGLT inhibitor for the treatment of recent-onset T1D. Method: An open label, prospective pilot study in adults with recent-onset T1D was performed. Empagliflozin, 25 mg orally daily, was given in combination with insulin and multidisciplinary care during a 24-week treatment phase, followed by wash-out visits at weeks 30 and 36. Results: Fourteen participants (4 women; median age 26 years) began and 13 completed the study. No treatment-emergent serious adverse events were observed, with fatigue and genital infection the most common side-effects. Four participants stopped mealtime insulin for at least one month when taking empagliflozin. At week 24, median weight, HbA1c and insulin dose decreased by 4.4 kg, 1.5% (17 mmol/mol) and 0.03 units/kg/day, respectively. Meal-stimulated C-peptide was maintained during the treatment phase and then decreased at 36 weeks. Conclusions: Treatment of adults with empagliflozin within 100 days of T1D diagnosis appeared safe and was associated with improved clinical outcomes. These findings justify a definitive trial to determine if SGLT inhibitors simplify treatment regimens and improve clinical outcomes in recent-onset T1D. Registration: ACTRN12617000016336. Keywords: Type 1 diabetes, SGLT-2 inhibitor, Clinical trial, Beta-cell function, Feasibility study |
url |
http://www.sciencedirect.com/science/article/pii/S2589936820300013 |
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