Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

Phase 2 Completed 36 enrolled Lexicon Pharmaceuticals Sanofi · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).

Timeline

Start: 2013-02
Primary completion: 2014-01
Completion: 2014-01

Outcome

Met primary endpoint

paper In the sotagliflozin-treated group, the percent reduction from baseline in the primary end point of bolus insulin dose was 32.1% (P = 0.007), PMID 26049551 ↗

registry analysis (superiority test); Placebo - Expansion Group vs Sotagliflozin 400 mg - Expansion Group; p = 0.007; LS Mean Difference -25.14 (95% CI -42.78 to -7.49) NCT01742208 ↗

Publications

Sands AT, Zambrowicz BP, Rosenstock J, Lapuerta P, Bode BW, Garg SK, Buse JB, Banks P, Heptulla R, Rendell M, Cefalu WT, Strumph P. Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes. Diabetes Care. 2015 Jul;38(7):1181-8. doi: 10.2337/dc14-2806. Epub 2015 Jun 6.

Drugs

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