Background: The indication for treatment of type 1 diabetes (T1D) with the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin has been withdrawn from the European market likely because of concern for diabetic ketoacidosis (DKA) . We aimed to calculate the incidence of DKA in people with T1D treated with SGLT2i in Denmark.
Methods: The study is based on clinical data from adults with T1D in Denmark, diagnosed according to the treating specialist and carefully selected for treatment with SGLT2i. Data were collected from nine outpatient clinics. Our National electronic health record system makes it is possible to search for a specific diagnosis both in an outpatient setting and during hospitalization, which makes the search for DKA accurate.
Results: From a population of 10.500 adults with T1D followed at the nine sites, we observed 134 people treated with SGLT2i over a total period of 222 patient years. Of them 72% were female, mean age (SD) was 51.4 (13.6) years and median duration of treatment (median, IQR) with an SGLT2i were 12.0 (6.0-29.0) months. The incidence of DKA was 0%.
Conclusion: In this retrospective observational study based on reported data from nine participating centers in Denmark in 134 people with T1D treated with SGLT2i we found that none of the participants developed DKA during the treatment.
E.Buur stougaard: Other Relationship; Novo Nordisk. K.W.Hansen: Advisory Panel; Abbott Diagnostics. H.H.Thomsen: Other Relationship; Boehringer Ingelheim International GmbH. T.Al-imari: None. M.Røder: None. P.Rossing: Consultant; Astellas Pharma Inc., AstraZeneca, Bayer AG, Gilead Sciences, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Speaker's Bureau; Eli Lilly and Company. F.Persson: Advisory Panel; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Research Support; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. P.L.Kristensen: Speaker's Bureau; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. U.Kielgast: Advisory Panel; Abbott, Eli Lilly and Company, Mundipharma, Novo Nordisk, Sanofi, Consultant; Boehringer Ingelheim International GmbH, Other Relationship; Boehringer Ingelheim International GmbH, Novo Nordisk, Novo Nordisk. H.U.Andersen: Advisory Panel; Abbott Diabetes, Stock/Shareholder; Novo Nordisk A/S. Y.H.Hamid: n/a. P.Gæde: Advisory Panel; AstraZeneca, Research Support; Novo Nordisk. E.Søndergaard: None. G.Dørflinger: None. K.K.Fjeldborg: Other Relationship; AstraZeneca.