A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

Phase 3 Completed 1405 enrolled Lexicon Pharmaceuticals Sanofi · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Timeline

Start: 2015-09
Primary completion: 2017-04
Completion: 2017-04

Outcome

Met primary endpoint

paper A significantly larger proportion of patients in the sotagliflozin group than in the placebo group achieved the primary end point PMID 28899222 ↗

registry analysis (superiority test); Placebo vs Sotagliflozin 400 mg; p < 0.001 NCT02531035 ↗

Publications

Garg SK, Henry RR, Banks P, Buse JB, Davies MJ, Fulcher GR, Pozzilli P, Gesty-Palmer D, Lapuerta P, Simo R, Danne T, McGuire DK, Kushner JA, Peters A, Strumph P. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med. 2017 Dec 14;377(24):2337-2348. doi: 10.1056/NEJMoa1708337. Epub 2017 Sep 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sotagliflozin	Small molecule	400 mg	Oral