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Characteristics and Rates of Diabetic Ketoacidosis (DKA) Among Users of Sodium-Glucose Co-Transporter 2 (SGLT-2) Inhibitors, Sitagliptin, or Short/Rapid-Acting Insulin: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
short/rapid-acting insulin
sitagliptin
sodium-glucose co-transporter-2 (SGLT-2) inhibitors
Health Outcome(s)
diabetic ketoacidosis
Description

In this report, we described characteristics of individuals with sodium-glucose co-transporter-2 (SGLT-2) inhibitor dispensings or sitagliptin dispensings, with or without type 1 diabetes or type 2 diabetes, as well as individuals with short/rapid-acting insulin and type 1 diabetes mellitus (T1DM), in the Sentinel Distributed Database (SDD). Among these cohorts, we assessed occurrence of diabetic ketoacidosis (DKA) and calculated incidence rates.

The study period includes data from March 1, 2013 to February 29, 2024. We distributed this request to six Sentinel Data Partners on October 23, 2024.

Please note that an earlier version of these results was presented at the October 31, 2024 Advisory Committee Meeting. For the results found below, the analysis was updated to further refine the algorithm used to define T1DM. For a copy of the earlier results, please contact info@sentinelsystem.org.

Deliverables (1)
Sentinel Modular Program Report: Characteristics and Rates of Diabetic Ketoacidosis (DKA) Among Users of Sodium-Glucose Co-Transporter 2 (SGLT-2) Inhibitors, Sitagliptin, or Short/Rapid-Acting Insulin: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
March 1, 2013 - February 29, 2024
Analysis Type
Descriptive
Population / Cohort
All individuals
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors & Diabetic Ketoacidosis (DKA) and Use in Type 1 Diabetes Mellitus (T1DM)
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee: Sotagliflozin and Diabetic Ketoacidosis (October 31, 2024)
Sentinel Drug Analysis: Characteristics and Rates of Diabetic Ketoacidosis (DKA) by Chronic Kidney Disease (CKD) Stage Among Patients with Short/Rapid-Acting Insulin Use and Type 1 Diabetes Mellitus (T1DM): A Descriptive Analysis
Sentinel Drug Analysis: Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitor Use in Patients with Diabetes Mellitus: A Descriptive Analysis
Sentinel Drug Analysis: SGLT-2 Inhibitor Use and Incidence of Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus