Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

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

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Sotagliflozin 200 mg; p <0.001; Least squares mean difference -0.48 (95% CI -0.75 to -0.22); MMRM; note: Threshold for significance \< 0.05 NCT02459899 ↗

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

Indications