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SGLT-2 Inhibitor Use and Incidence of Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus

Basic Details
Date Posted
Status
Complete
Medical Product
canagliflozin
dapagliflozin
empagliflozin
sitagliptin
sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Health Outcome(s)
diabetic ketoacidosis
Description

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.

Deliverables (1)
Sentinel Modular Program Report: SGLT-2 Inhibitor Use and Incidence of Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus
Additional Details
FDA Center
CDER
Analysis Type
Descriptive
Population / Cohort
Patients with Type 1 Diabetes Mellitus
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee: SGLT-2 Inhibitors and Diabetic Ketoacidosis (January 17, 2019)
2019 ICPE Presentation: Analysis of SGLT2 Inhibitor Use in Patients with Type-1 Diabetes Mellitus and Rates of Diabetic Ketoacidosis
Use of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis
Sentinel Drug Study: Sodium-Glucose Cotransporter-2 (SGLT-2) Inhibitors & Diabetic Ketoacidosis (DKA) and Use in Type 1 Diabetes Mellitus (T1DM)