Skip to main content

Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors & Diabetic Ketoacidosis (DKA) and Use in Type 1 Diabetes Mellitus (T1DM)

Basic Details
Status
Ongoing
Last Updated
Tuesday, August 5, 2025
Original Posting Date
Health Outcome(s)
diabetic ketoacidosis (DKA)
use in type 1 diabetes mellitus (T1DM)
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

In response to clinical trials showing an increased risk of diabetic ketoacidosis (DKA) with sotagliflozin in type 1 diabetes mellitus (T1DM), the FDA assessed off-label use of sodium-glucose co-transporter 2 (SGLT2) inhibitors (approved for use in type 2 diabetes mellitus) and real-world rates of DKA when used in patients with T1DM. Elevated rates of DKA with off label SGLT2 inhibitor use among patients with T1DM were seen compared to clinical trials. These findings were presented at the January 17, 2019 Advisory Committee meeting for sotagliflozin, and this helped inform the committee member discussion on the benefit-risk assessment.

Analytic Code Link(s) (1)
Rates of Diabetic Ketoacidosis (DKA) by Chronic Kidney Disease (CKD) Stage Among Patients with Type 1 Diabetes Mellitus (T1DM): A Propensity Score Matched Analysis
Result(s) (4)
SGLT2 Inhibitor Use and Incidence of Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitor Use in Patients with Diabetes Mellitus: A Descriptive Analysis 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 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
Regulatory Link(s) (2)
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee: SGLT-2 Inhibitors and Diabetic Ketoacidosis (January 17, 2019) Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting: Sotagliflozin and Diabetic Ketoacidosis (October 31, 2024)
Related Publication(s) and/or Presentation(s) (2)
Presentation: Analysis of SGLT2 Inhibitor Use in Patients with Type-1 Diabetes Mellitus and Rates of Diabetic Ketoacidosis Publication: Use of Sodium–Glucose Co-Transporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis