Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sotagliflozin · 1 trial · 4 indications
eGFR at the end of the 8-week drug washout period following the 3-year treatment period, estimated from Central Lab serum creatinine and cystatin C using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and adjusted by its baseline value. Baseline and end-of-washout eGFRs will be considered as the average of two eGFR values taken on two separate days before randomization (V2 and V4) and after the washout (V18 and V19), respectively.
| Arm | Type | Description |
|---|---|---|
| Sotagliflozin | ACTIVE_COMPARATOR | Oral sotagliflozin at a dose of 200 mg (one tablet) per day for three years followed by a 2-month wash-out period. |
| Placebo | PLACEBO_COMPARATOR | Oral tablets similar to sotagliflozin tablets but containing no active drug (one tablet per day for three years followed by a 2-month wash-out period). |
| Name | Type | Description |
|---|---|---|
| Sotagliflozin | DRUG | Oral sotagliflozin (200 mg per day) |
| Placebo | DRUG | Inactive tablets identical to sotagliflozin tablets |
Inclusion Criteria: * Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis. * Duration of T1D ≥ 8 years; * eGFR based on serum creatinine and cystatin c (2021 serum creatinine-cystatin C CKD-EPI equation) between 20 and 60 ml/min/1.73 m2 at screening (with the optio...