Table 1

Design features and main outcomes of large randomized clinical trials evaluating efficacy and safety of SGLTi in T1D

Drug testedParticipants(N)Study duration(weeks)Age(years)BMI(kg/m2)A1C at baseline [%]A1C change vs. placebo(%)Weight changevs. placebo(kg)DKA events(% incidence)
Canagliflozin 100 mg351184228.17.9−0.29−2.84.3
Canagliflozin 300 mg−0.25−4.46.0
Placebo0
(Henry et al. [12])
Sotagliflozin 400 mg1,402244328.28.2−0.46−3.03.0
Placebo0.6
(Garg et al. [13])
Sotagliflozin 200 mg793524629.77.6−0.25−3.13.4
Sotagliflozin 400 mg−0.31−4.34.2
Placebo0.4
(Buse et al. [14])
Sotagliflozin 200 mg782524127.87.75−0.21−2.22.3
Sotagliflozin 400 mg−0.32−2.93.4
Placebo0
(Danne et al. [15])
Dapagliflozin 5 mg833524228.38.5−0.33−2.954.0
Dapagliflozin 10 mg−0.36−4.53.4
Placebo1.9
(Dandona et al. [16])
Dapagliflozin 5 mg813244327.68.4−0.37−3.22.6
Dapagliflozin 10 mg−0.42−3.72.2
Placebo0
(Mathieu et al. [17])
Empagliflozin 10 mg EASE-2723264529.28.1−0.39−2.74.3*
Empagliflozin 25 mg EASE-2−0.45−3.33.3*
Placebo EASE-21.2
Empagliflozin 2.5 mg EASE-3961524328.28.1−0.28−1.80.8
Empagliflozin 10 mg EASE-3−0.45−3.04.3*
Empagliflozin 25 mg EASE-3−0.52−3.43.3*
Placebo EASE-31.2
(Rosenstock et al. [18])
  • Mean values are shown where appropriate. EASE, Empagliflozin as Adjunctive to Insulin Therapy Program.

  • * Participants taking 10 and 25 mg of empagliflozin in the two components of the EASE program were pooled for this analysis.