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 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.