Table 1.
Clinical Trials in People with Type 1 Diabetes |
||||||||
---|---|---|---|---|---|---|---|---|
| ||||||||
DEPICT 1 | DEPICT 2 | inTandem 1 | inTandem 2 | inTandem 3 | EASE 1 | EASE 2 | EASE 3 | |
Number of patients,an | 556 | 442 | 530 | 521 | 1402 | 37 | 487 | 486 |
Study drug | DAPA | DAPA | SOTA | SOTA | SOTA | EMPA | EMPA | EMPA |
Drug high dose (mg) | 10 | 10 | 400 | 400 | 400 | 25 | 25 | 25 |
Study duration (weeks) | 52 | 24 | 52 | 52 | 24 | 4 | 52 | 26 |
Baseline HbA1c (%) | 8.5 | 8.4 | 7.5 | 7.8 | 8.2 | 8.2 | 8.1 | 8.2 |
Change in HbA1cb (%) | −0.36 | −0.42 | −0.31 | −0.32 | −0.46 | −0.49 | −0.45 | −0.52 |
Change in insulin TDDb (%) | ∼−10 | −11.1 | −12.6 | −8.2 | −9.7 | −13 | −12.9 | −12.6 |
Change in body weightb (kg) | −3.6 | −3.0 | −4.3 | −2.9 | −3.0 | −1.9 | −3.6 | −3.4 |
Change in time in rangeb,c (%) | +10.7 | +10.4 | +13.4 | NA | +10.9 | +12.5 | +7.4 | |
Ketoacidosis incidence rates,d,en | 13 versus 3 | 3 versus 0 | 11 versus 1 | 9 versus 0 | 21 versus 4 | 0 versus 0 | 16 versus 6 |
High-dose treatment with SGLT1 or SGLT2 inhibitor: dapagliflozin 10 mg, EMPA 25 mg or sotagliflozin 400 mg.
Including placebo and high-dose SGLT1 or SGLT2 inhibitor treatment group.
Placebo-adjusted.
CGM data for DEPICT-1 and DEPICT-2 were pooled for analyses.
Incidence rates for SGLT1/2 inhibitor versus placebo.
Ketoacidosis incidence rates were pooled for EASE 2 and EASE 3 studies.
DAPA: dapagliflozin; SOTA, sotagliflozin; TDD, total daily dosage; NA, not available.