. 2019 Nov 26;10:2042018819890527. doi: 10.1177/2042018819890527

Table 3.

Efficacy endpoints across randomized controlled trials of sotagliflozin in type 1 diabetes.

Study	Study arms	Change in A1C (%) from baseline to 24 weeks	Change in A1C (%) from baseline until end of study (difference from placebo)		Net benefit⁺ (%) from baseline until end of study (difference from placebo)		Change in weight (kg) from baseline until end study (difference from placebo)		Percent change in TDD of insulin from baseline until end of study (difference from placebo)		Change in FPG (mg/dl) from baseline until end of study (difference from placebo)		Change in SBP (mm Hg) from baseline until end of study (difference from placebo)
*Buse et al.* (inTandem1) ²³ North America			24w	52w	24w	52w	24w	52w	24w	52w	24w	52w	24w	52w
	Placebo	−0.07^*	–	–	–	–	–	–	–	–	–	–	–	–
	Sotagliflozin 200 mg	−0.43^*^Δ	−0.36^*	−0.25^*	12^*	13.4^*	−2.35^*	−3.14^*	−6.16^*	−8.02^*	−9.8^*	−12.2^*	−3.5^*	−2.8^*
	Sotagliflozin 400 mg	−0.48^*^Δ	−0.41^*	−0.31^*	22^*	7.2^*	−3.45^*	−4.32^*	−9.70^*	−12.64^*	−17.8^*	−19.4^*	−4.2^*	−4.4^*
*Danne et al.* (inTandem2) ²⁴ European Union and Israel			24w	52w	24w	52w	24w	52w	24w	52w	24w	52w	24w	52w
	Placebo	−0.02	–	–	–	–	–	–	–	–	–	–	–	–
	Sotagliflozin 200 mg	−0.39^*^Δ	−0.37^*	−0.21^*	16.3^*	11.3^*	−1.98^*	−2.18^*	−8.23^*	−6.26^*	−21.6^*	−4.9	−0.4	−3.0^*
	Sotagliflozin 400 mg	−0.37^*^Δ	−0.35^*	−0.32^*	17.2^*	12.3^*	−2.58^*	−2.92^*	−9.47^*	−8.17^*	−25.7^*	−15.8^*	−2.8^*	−2.8^*
*Garg et al.* (inTandem3) ²⁵ 19 countries	Placebo	−0.33^*	–		–		–		–		–		–
*Garg et al.* (inTandem3) ²⁵ 19 countries	Sotagliflozin 400 mg	−0.79^*	−0.46^*		13.4^*^Δ		−2.98^*		−9.71^*		−23.2^*		−3.5^*⁺⁺

Statistically significant.

^Δ

Primary endpoint.

⁺

Proportion of patients with A1C <7% without any episode of SH or DKA.

⁺⁺

Difference between groups at 16 weeks (not evaluated at 24 weeks).

DKA, diabetic ketoacidosis; FPG, fasting plasma glucose; SH, severe hypoglycemia; TDD: total daily dose.