Table 2.
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