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

Project Title SGLT-2 Inhibitor Use and Incidence of Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus
Date Posted
Tuesday, March 19, 2019
Project ID
cder_mpl1p_wp026
Status
Complete
Deliverables
Related Links
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.

Medical Product
canagliflozin
dapagliflozin
empagliflozin
sitagliptin
sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Health Outcome
diabetic ketoacidosis
Population / Cohort
Patients with Type 1 Diabetes Mellitus
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER