NCT03063580 is a Phase 1 clinical trial of Sotagliflozin (SAR439954) in Diabetes Mellitus, sponsored by Sanofi.

Who is sponsoring NCT03063580?

NCT03063580 is sponsored by Sanofi.

What drugs are being tested in NCT03063580?

Interventions in NCT03063580: Sotagliflozin (SAR439954), Rifampicin.

What condition does NCT03063580 study?

NCT03063580 studies Diabetes Mellitus.

Is NCT03063580 still recruiting?

NCT03063580 is currently completed. Last updated 25 April 2022.

Last reviewed 2022-04-25 · How we verify

NCT03063580

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

Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin

Completed Phase 1 Last updated 25 April 2022

What this trial tests

Phase 1 trial testing Sotagliflozin (SAR439954) in Diabetes Mellitus in 16 participants. Completed in 12 May 2017.

Timeline

27 February 2017

Primary endpoint
12 May 2017

12 May 2017

Quick facts

Lead sponsor	Sanofi
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	16
Start date	27 February 2017
Primary completion	12 May 2017
Estimated completion	12 May 2017
Sites	1 location across France

Drugs / interventions tested

Sotagliflozin (SAR439954) — full drug profile →
Rifampicin (Rifampicin) — full drug profile →

Conditions studied

Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 55, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective: To evaluate the effects of rifampicin on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects. Secondary Objectives: * To assess total 24-hour urinary glucose excretion (UGE) after a dose of sotagliflozin 400 mg, alone and with rifampicin, in healthy male and female subjects. * To assess the safety and tolerability of single dose sotagliflozin with and without rifampicin in healthy male and female subjects.

Publications & conference data

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

Enhancing of cerebral Abeta clearance by modulation of ABC transporter expression: a review of experimental approaches.
Loeffler DA. · · 2024 · cited 2× · PMID 38872626 · DOI 10.3389/fnagi.2024.1368200

Verify or expand the search:

Other trials of Sotagliflozin (SAR439954)

Trials testing the same drug.

NCT03909451 — Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects · Phase 1 · completed
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

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 NCT03063580 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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/NCT03063580.

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