Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

Phase 2 Completed 299 enrolled Lexicon Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.

Timeline

Start: 2011-06
Primary completion: 2012-05
Completion: 2012-05

Outcome

Met primary endpoint

paper LX4211 significantly reduced A1C to week 12 in a dose-dependent manner by 0.42% (4.6 mmol/mol), 0.52% (5.7 mmol/mol), 0.80% (8.7 mmol/mol), and 0.92% PMID 25216510 ↗

paper P < 0.001 each), compared with 0.09% (1.0 mmol/mol) for placebo. PMID 25216510 ↗

Publications

Rosenstock J, Cefalu WT, Lapuerta P, Zambrowicz B, Ogbaa I, Banks P, Sands A. Greater dose-ranging effects on A1C levels than on glucosuria with LX4211, a dual inhibitor of SGLT1 and SGLT2, in patients with type 2 diabetes on metformin monotherapy. Diabetes Care. 2015 Mar;38(3):431-8. doi: 10.2337/dc14-0890. Epub 2014 Sep 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sotagliflozin	Small molecule	75 mg	—
Subject	Sotagliflozin	Small molecule	200 mg	—
Subject	Sotagliflozin	Small molecule	400 mg	—