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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03462069 | Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension | PHASE2 | COMPLETED | 41 | — | — | Mar 12, 2018 | Apr 18, 2019 | Apr 25, 2022 | 1 | Germany |
| NCT03909451 | Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects | PHASE1 | COMPLETED | 24 | — | — | Apr 28, 2019 | Aug 19, 2019 | Apr 25, 2022 | 1 | China |
| NCT03414723 | A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril | PHASE1 | COMPLETED | 16 | — | — | Jan 15, 2018 | Mar 10, 2018 | Apr 25, 2022 | 1 | Germany |
| NCT03174548 | A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects | PHASE1 | COMPLETED | 14 | — | — | Jun 12, 2017 | Sep 15, 2017 | Apr 25, 2022 | 1 | United Kingdom |
| NCT03070678 | Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects | PHASE1 | COMPLETED | 16 | — | — | Mar 14, 2017 | Apr 18, 2017 | Apr 25, 2022 | 1 | France |
| NCT03063580 | Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin | PHASE1 | COMPLETED | 16 | — | — | Feb 27, 2017 | May 12, 2017 | Apr 25, 2022 | 1 | France |
Change from baseline in fecal sodium excretion
Change from baseline in 24-hour urinary glucose excretion
14 hour plasma glucose profile after standardized meals
Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE)
Sotagliflozin with ramipril: Area under the curve (AUC) to the end of the dosing period (AUCtau)
| Arm | Type | Description |
|---|---|---|
| Treatment A (Test) | EXPERIMENTAL | Sotagliflozin 2 tablets administered once daily with 1 empagliflozin placebo capsule prior to the first meal of the day |
| Treatment B (Reference) | ACTIVE_COMPARATOR | Empagliflozin 1 capsule administered once daily with 2 sotagliflozin placebo tablets prior to the first meal of the day |
| Dose 1 | EXPERIMENTAL | Sotagliflozin dose 1, once daily for 8 days |
| Dose 2 | EXPERIMENTAL | Sotagliflozin dose 2, once daily for 8 days |
| Placebo | PLACEBO_COMPARATOR | Placebo, once daily for 8 days |
| SAR439954 with or without ramipril | EXPERIMENTAL | * On Period 1, following an overnight fast, subjects will receive once daily single morning oral intake of sotagliflozin from Day 1 to Day 5 followed by the first meal that has to be started within 10 min after dosing. * On Day 1 of the Period 2, study subjects will begin a 10-day ramipril regimen following an overnight fast. From Day 6 to Day 10, subjects will receive once daily single morning oral intake of ramipril concomitantly to the sotagliflozin dosing. |
| Fed Tablet period (Test, T) | EXPERIMENTAL | Sotagliflozin oral in fed conditions |
| Fasted Tablet period (Reference, R) | EXPERIMENTAL | Sotagliflozin oral in fasting conditions |
| Oral Solution period (S) | EXPERIMENTAL | Sotagliflozin oral solution in fasting conditions |
| SAR439954 with or without mefenamic acid | EXPERIMENTAL | Period 1: single oral dose of 400 mg sotagliflozin Period 2: initial loading dose of 500 mg in the morning of Day 1, followed by 250 mg from Day 1 H6 to Day 7 of mefenamic acid and a single oral dose of sotagliflozin on Day 2 |
| SAR439954 with or without rifampicin | EXPERIMENTAL | Period 1: single oral dose of 400 mg sotagliflozinon Day 1 morning Period 2: once-daily oral doses of 600 mg rifampicin from Days 1 to 10 and a single oral dose of 400 mg sotagliflozin |
| Name | Type | Description |
|---|---|---|
| Sotagliflozin (SAR439954) | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Placebo | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Empagliflozin | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| Ramipril | DRUG | Pharmaceutical form: tablets Route of administration: oral |
| Mefenamic acid | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| Rifampicin | DRUG | Pharmaceutical form: capsules Route of administration: oral |
Inclusion criteria : * Male or female patients with Type 2 Diabetes Mellitus (T2DM) (diagnosed at least 1 year before screening visit), between 18 and 74 years of age, inclusive, with: * Hypertension grades 1 or 2 as defined by the European Society of Hypertension (ESH)/European Society of Cardi...