Table 2.

Summary of study design and baseline patient characteristics of inTandem studies evaluating sotagliflozin in type 1 diabetes.

Study	Design	Baseline patient characteristics	Run-in time prior to randomization	Baseline glucose and insulin dose at randomization	Study arms
Buse et al. (inTandem1) 23 North America	Double-blind; 52 weeks (24w core, 28w long term extension); n = 793	Mean age 46 years; 52% female; 92% white; BMI 29.7 kg/m2; DM duration 24.4 years; 40.4% used MDI	Insulin optimization for 6 weeks with a 2 week placebo run-in	A1C 7.6% FPG 152 mg/dl TDD: 64–67 IU/ day	Placebo Sotagliflozin 200 mg daily Sotagliflozin 400 mg daily
Danne et al. (inTandem2) 24 European Union and Israel	Double-blind; 52 weeks (24w core, 28w long term extension); n = 782	Mean age 41 years; 48% female; 96% white; BMI 27.8 kg/m2; DM duration 18.4 years; 74.3% used MDI	Insulin optimization for 6 weeks with a 2-week placebo run-in	A1C 7.8% FPG 163 mg/dl TDD: 60–62 IU/day	Placebo Sotagliflozin 200 mg daily Sotagliflozin 400 mg daily
Garg et al. (inTandem3) 25 19 countries	Double-blind; 24 weeks; n = 1402	Mean age 43 years; 50% female; 88% white; BMI 28 kg/m2; DM duration 20 years; 60.4% used MDI	Single-blind placebo run-in for 2 weeks	A1C 8.2% FPG 164 mg/dl TDD: 57–58 IU/day	Placebo Sotagliflozin 400 mg daily

A1C, hemoglobin A1C; BMI, body mass index; DM, diabetes mellitus; FPG, fasting plasma glucose; MDI, multiple daily injections; TDD, total daily dose.