Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

Phase 2 Completed 141 enrolled Lexicon Pharmaceuticals Sanofi · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.

Timeline

Start: 2015-07
Primary completion: 2016-08
Completion: 2016-08

Publications

Baker C, Wason S, Banks P, Sawhney S, Chang A, Danne T, Gesty-Palmer D, Kushner JA, McGuire DK, Mikell F, O'Neill M, Peters AL, Strumph P. Dose-dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12 weeks: The inTandem4 trial. Diabetes Obes Metab. 2019 Nov;21(11):2440-2449. doi: 10.1111/dom.13825. Epub 2019 Aug 1.

Drugs

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

Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

Summary

Timeline

Publications

Drugs

Indications