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. 2018 Aug 22;61(10):2126–2133. doi: 10.1007/s00125-018-4671-6

Table 2.

Summary of major placebo-adjusted efficacy measures from reported Phase III studies involving SGLT inhibitor adjunct therapy in type 1 diabetes

Efficacy measure (PBO adjusted) Dapagliflozin Sotagliflozin
DEPICT-1a inTandem1a inTandem2a inTandem3
HbA1c change DAPA 5 mg: −4.6 mmol/mol (−0.42%) (p < 0.0001)
DAPA 10 mg: −5.0 mmol/mol (−0.45%) (p < 0.0001)
SOTA 200 mg: −4.0 mmol/mol (−0.36%) (p < 0.001)
SOTA 400 mg: −4.5 mmol/mol (−0.41%) (p < 0.001)
SOTA 200 mg: −4.0 mmol/mol (−0.36%) (p < 0.001)
SOTA 400 mg: −3.9 mmol/mol (−0.35%) (p < 0.001)
SOTA 400 mg: −5.1 mmol/mol (−0.46%) (p < 0.001)
Secondary (composite) endpoint and per cent achieving this HbA1c reduction ≥6 mmol/mol (≥0.5%) without SH
PBO: 25%
DAPA 5 mg: 50%
DAPA 10 mg: 51%
HbA1c <53 mmol/mol (<7.0%), no SH, no DKA
PBO: 22%
SOTA 200 mg: 34%
SOTA 400 mg: 44%
HbA1c <53 mmol/mol (<7.0%), no SH, no DKA
PBO: 15%
SOTA 200 mg: 31%
SOTA 400 mg: 32%
HbA1c <53 mmol/mol (<7.0%), no SH, no DKA
PBO: 15.2%
SOTA 400 mg: 28.6%
HbA1c reduction ≥6 mmol/mol (≥0.5%) without SH
PBO: 36.7%
SOTA 400 mg: 60.9%
Change from baseline in total insulin dose (%) DAPA 5 mg: −8.8% (p < 0.0001)
DAPA 10 mg: −13.2% (p < 0.0001)
NA NA SOTA 400 mg: −9.71% (p < 0.001)
Mean change in SBP NA SOTA 200 mg: −5.4 mmHg (p = 0.017)
SOTA 400 mg: −6.6 mmHg (p = 0.003)
NA SOTA 400 mg: −3.5 mmHg (p = 0.002)
Mean change from baseline in body weight DAPA 5 mg: −2.96% (p < 0.0001)
DAPA 10 mg: −3.72% (p < 0.0001)
SOTA 200 mg: −2.4 kg (p < 0.001)
SOTA 400 mg: −3.5 kg (p < 0.001)
SOTA 200 mg: −2.0 kg (p < 0.001)
SOTA 400 mg: −2.6 kg (p < 0.001)
SOTA 400 mg: −3.0 kg (p < 0.001)

aThis table shows 24 week data from DEPICT, inTandem1 and inTandem2

DAPA, dapagliflozin; NA, data not publicly available; PBO, placebo; SH, severe hypoglycaemia; SOTA, sotagliflozin