SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus

NCT04201496 ↗

Phase 1 Completed 34 enrolled Ananda Basu, MD DexCom, Inc. · collab National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab Tandem Diabetes Care, Inc. · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The primary purpose of this study is to evaluate the safety and efficacy of combining SGLT2 inhibitors with closed loop control (CLC).

Timeline

Start: 2020-02-24
Primary completion: 2021-09-07
Completion: 2021-09-07

Outcome

Met primary endpoint

paper On AID, EMPA versus NOEMPA had higher daytime TIR 81% versus 71% with a mean estimated difference of +9.9% (confidence interval [95% CI] 0.6-19.1); p = 0.04. PMID 35255229 ↗

Publications

Garcia-Tirado J, Farhy L, Nass R, Kollar L, Clancy-Oliveri M, Basu R, Kovatchev B, Basu A. Automated Insulin Delivery with SGLT2i Combination Therapy in Type 1 Diabetes. Diabetes Technol Ther. 2022 Jul;24(7):461-470. doi: 10.1089/dia.2021.0542. Epub 2022 Mar 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	5 mg	—
Subject	Empagliflozin	Small molecule	10 mg	—