Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sotagliflozin · 12 trials · 4 indications
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)
Maximum plasma concentration observed
Truncated AUC 0-72h
Absolute Bioavailability (F) will be a composite endpoint and include Area under plasma concentration (AUC) dose normalized for intravenous (IV) 14C-IMP AUClast dose normalized for oral Investigational Medicinal Product (IMP)
Sotagliflozin with ramipril: Area under the curve (AUC) to the end of the dosing period (AUCtau)
Sotagliflozin: Area under the concentration-time curve from 0 to infinity (AUC) for reference, p1, p2, and p3 formulations
Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration for reference, p1, p2, and p3 formulations
Sotagliflozin: Maximum plasma concentration (Cmax) for reference, p1, p2, and p3 formulations
Sotagliflozin: Maximum plasma concentration (Cmax)
Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Sotagliflozin: Area under the concentration-time curve from 0 to infinity
| 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 |
| Sotagliflozin Test | EXPERIMENTAL | One tablet of sotagliflozin administered orally under fasting conditions |
| Sotagliflozin Reference | ACTIVE_COMPARATOR | Two tablets of sotagliflozin administered orally under fasting conditions |
| Sotagliflozin | EXPERIMENTAL | One treatment period includes a single oral dose of sotagliflozin + IV microdose 14C-sotagliflozin tracer plus charcoal. The other treatment period includes a single oral dose of sotagliflozin + IV microdose 14C-sotagliflozin tracer without charcoal. |
| 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. |
| Sotagliflozin + Hydrochlorothiazide (HCTZ) | EXPERIMENTAL | Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days. |
| Sotagliflozin dose 1 (reference formulation) | ACTIVE_COMPARATOR | Single oral dose on Day 1 of one of the four period in fasting condition |
| Sotagliflozin dose 2 (prototype p1 formulation) | EXPERIMENTAL | Single oral dose on Day 1 of one of the four period in fasting condition |
| Sotagliflozin dose 3 (prototype p2 formulation) | EXPERIMENTAL | Single oral dose on Day 1 of one of the four period in fasting condition |
| Sotagliflozin dose 4 (prototype p3 formulation) | EXPERIMENTAL | Single oral dose on Day 1 of one of the four period in fasting condition |
| Sotagliflozin - Commerical | EXPERIMENTAL | Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Commercial formulation) by mouth under fasted conditions |
| Sotagliflozin -Development | ACTIVE_COMPARATOR | Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Development formulation) by mouth under fasted conditions - Type: Active Comparator |
| 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 |
| Cohort 1 | EXPERIMENTAL | Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days |
| Cohort 2 | EXPERIMENTAL | Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days |
| 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 |
| 14C-microtracer | DRUG | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
| Charcoal | DRUG | Pharmaceutical form: Granules for suspension Route of administration: Oral |
| Ramipril | DRUG | Pharmaceutical form: tablets Route of administration: oral |
| Hydrochlorothiazide | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| Mefenamic acid | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| Rifampicin | DRUG | Pharmaceutical form: capsules Route of administration: oral |
| midazolam | DRUG | Pharmaceutical form: HCl syrup Route of administration: oral |
| metoprolol | DRUG | Pharmaceutical form: tablet 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...
Sotagliflozin is an investigational small molecule being developed for Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, and Diabetes Mellitus. It is in Phase 2 clinical development and is not yet approved by the FDA. The drug is being studied for its effects on blood sugar control in patients with these metabolic conditions.
Sotagliflozin is being developed by Sanofi, a company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of diabetes mellitus.
Sotagliflozin is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, and Diabetes Mellitus.
Sotagliflozin has completed six clinical trials, including NCT02940379, NCT03211195, NCT03387657, and NCT03802487. These trials were Phase 1 studies evaluating drug interactions, bioequivalence, and bioavailability in healthy volunteers and patients with Type 2 Diabetes Mellitus. All trials are completed, with no active trials currently ongoing.
Sotagliflozin is a small molecule that works by targeting sodium-glucose cotransporters, which are proteins involved in glucose reabsorption in the kidneys and intestines. By inhibiting these targets, the drug aims to reduce blood glucose levels in patients with diabetes mellitus.