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...
Sotagliflozin is an investigational small molecule being studied to slow kidney function decline in persons with type 1 diabetes and diabetic kidney disease. It is in Phase 3 clinical development for diabetic nephropathies, a condition under the cardiovascular therapeutic area.
Sotagliflozin targets and inhibits SLC5A1 and SLC5A2, which are sodium-glucose cotransporters. By inhibiting these targets, the drug is being evaluated for its effects on kidney function in patients with diabetic kidney disease.
Sotagliflozin is being developed by DexCom, Inc., a company traded under the ticker DXCM. The drug is currently in Phase 3 clinical development for diabetic nephropathies.
Sotagliflozin is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied in a randomized, double-blind, placebo-controlled trial for diabetic kidney disease.
Sotagliflozin is being evaluated in clinical trial NCT06217302, titled "Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease." This Phase 3 trial is recruiting 150 participants in the United States and Canada.
Sotagliflozin is also known by the ChEMBL identifier CHEMBL3039507. It is a distinct small molecule inhibitor of SLC5A1 and SLC5A2, and no other alternative names are documented for this drug.