Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07211802 | CKM For Safe Use of SGLT2i in Type 1 Diabetes | PHASE3 | NOT YET_RECRUITING | 52 | — | — | Jul 1, 2026 | Dec 31, 2030 | Oct 8, 2025 | 1 | United States |
Beta hydroxybutyrate (BHB) time \> 0.6 millimole per liter (mmol/L) as measured by the DGK during the 200mg dosing period in the MDI vs. HCL groups.
Beta hydroxybutyrate (BHB) time \> 0.6 mmol/L as measured by the DGK during the 400mg dosing period in the MDI vs. HCL groups.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A | EXPERIMENTAL | 200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks |
| Treatment Group B | EXPERIMENTAL | 400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks |
| Name | Type | Description |
|---|---|---|
| Sotagliflozin Low Dose | DRUG | 200 mg Sotagliflozin, once daily for 6 weeks |
| Sotagliflozin High Dose | DRUG | 400 mg Sotagliflozin, once daily for 6 weeks |
| Dual Continuous Glucose and Ketone Monitor | DEVICE | Abbott Libre X dual continuous glucose and ketone monitor (DGK) device. |
Inclusion Criteria: 1. All individuals between the ages of \>18 years old, inclusive, at the time of screening; 2. Individuals able to become pregnant must: 1. be ≥1 year post-menopausal or documented as being surgically sterile, or 2. agree to use two methods of contraception during the ent...