Table 4.
Adverse events across randomized controlled trials of sotagliflozin in type 1 diabetes.
| Study | Study arms | Severe hypoglycemia (%) | DKA (%) | Amputations (%) | Bone density/fractures (%) | Genital mycotic infections (%) | UTI (%) | Volume depletion (%) | Diarrhea (%) |
|---|---|---|---|---|---|---|---|---|---|
|
Buse et al.
(inTandem1) 1 North America |
Placebo | 9.7 | 0.4 | 0 | 3.7 | 3.4 | 7.1 | 1.5 | 6.7 |
| Sotagliflozin 200 mg | 6.5 | 3.4 | 0 | 3.4 | 9.1 | 9.9 | 3 | 8.4 | |
| Sotagliflozin 400 mg | 6.5 | 4.2 | 0.4 | 1.9 | 13 | 4.2 | 1.5 | 10.3 | |
|
Danne et al.
(inTandem2) 2 EU and Israel |
Placebo | 5 | 0 | 0 | 3.1 | 2.3 | 5 | 0.4 | 3.5 |
| Sotagliflozin 200 mg | 5 | 2.3 | 0.4 | 2.3 | 9.2 | 4.2 | 2.3 | 4.6 | |
| Sotagliflozin 400 mg | 2.3 | 3.4 | 0 | 1.9 | 11.0 | 6.8 | 0.8 | 7.2 | |
|
Garg et al.
(inTandem3) 3 19 countries |
Placebo | 2.4 | 0.6 | 0 | 0.7 | 2.1 | 3.8 | 0.3 | 2.3 |
| Sotagliflozin 400 mg | 3.0 | 3.0 | 0 | 0.6 | 6.4 | 3.6 | 1.9 | 4.1 |
DKA, diabetic ketoacidosis; UTI, urinary tract infection.