TabsDetailsBasic DetailsDate Posted: Tuesday, March 19, 2019Status: CompleteMedical Product: canagliflozin, dapagliflozin, empagliflozin, sitagliptin, sodium-glucose cotransporter-2 (SGLT-2) inhibitorHealth Outcome(s): diabetic ketoacidosisDescription: The goal of this request was to estimate rates of diabetic ketoacidosis (DKA) among new users of sodium-glucose cotransporter-2 (SGLT-2) inhibitors canagliflozin, dapagliflozin, empagliflozin, or sitagliptin in the Sentinel Distributed Database (SDD). Data from March 1, 2013 through June 30, 2018 from 17 Data Partners contributing to the SDD were included in this report. This request was distributed to Data Partners on November 28, 2018. Read More Deliverables (1)Sentinel Modular Program Report: SGLT-2 Inhibitor Use and Incidence of Diabetic Ketoacidosis in Patients with Type 1 Diabetes MellitusAdditional InformationAdditional DetailsFDA Center: CDERStudy Type: Modular ProgramAssessment Type: Exploratory AnalysesPopulation / Cohort: Patients with Type 1 Diabetes MellitusData Sources: Sentinel Distributed Database (SDD)Related Links: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee: SGLT-2 Inhibitors and Diabetic Ketoacidosis2019 ICPE Presentation: Analysis of SGLT2 Inhibitor Use in Patients with Type-1 Diabetes Mellitus and Rates of Diabetic KetoacidosisUse of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis
