NCT03909451 is a Phase 1 clinical trial of Sotagliflozin (SAR439954) in Diabetes Mellitus, sponsored by Sanofi.

Who is sponsoring NCT03909451?

NCT03909451 is sponsored by Sanofi.

What drugs are being tested in NCT03909451?

Interventions in NCT03909451: Sotagliflozin (SAR439954), Placebo.

What condition does NCT03909451 study?

NCT03909451 studies Diabetes Mellitus.

Is NCT03909451 still recruiting?

NCT03909451 is currently completed. Last updated 25 April 2022.

Last reviewed 2022-04-25 · How we verify

NCT03909451

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Completed Phase 1 Last updated 25 April 2022

What this trial tests

Phase 1 trial testing Sotagliflozin (SAR439954) in Diabetes Mellitus in 24 participants. Completed in 19 August 2019.

Timeline

28 April 2019

Primary endpoint
19 August 2019

19 August 2019

Quick facts

Lead sponsor	Sanofi
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	28 April 2019
Primary completion	19 August 2019
Estimated completion	19 August 2019
Sites	1 location across China

Drugs / interventions tested

Sotagliflozin (SAR439954) — full drug profile →
Placebo

Conditions studied

Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 45, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective: To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects. Secondary Objectives: * To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects. * To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Sotagliflozin After Multiple Ascending Doses in Chinese Healthy Subjects.
He X, Gao X, Xie P, Liu Y, et al · · 2022 · cited 7× · PMID 36097559 · DOI 10.2147/dddt.s372575

Verify or expand the search:

Other trials of Sotagliflozin (SAR439954)

Trials testing the same drug.

NCT03802487 — Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects · Phase 1 · completed
NCT03462069 — Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hyperten · Phase 2 · completed
NCT03414723 — A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril · Phase 1 · completed
NCT03387657 — A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide · Phase 1 · completed
NCT03332771 — Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That A · Phase 3 · completed

Other recruiting trials for Diabetes Mellitus

Currently open trials in the same condition.

NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07392437 — Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and I · NA · recruiting
NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
NCT07425275 — Integrated Oral Care Intervention for Xerostomia in Diabetes Patients · NA · recruiting
NCT06918977 — Improving Glycemic Control With Telemedicine and Smart Insulin Pens · NA · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03909451 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 25 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03909451.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing