A Phase 1 interventional study of Sotagliflozin (SAR439954) and Placebo in Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 1, Interventional, and Treatment
Primary Objective:
To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
Secondary Objectives:
The study duration per subject will be up to 41 days and will consist of a screening period of up to 28 days, a dosing period of 8 days, and a follow up visit 5 days after last dosing.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
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Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sotagliflozin dose 1, once daily for 8 days
Drug: Sotagliflozin (SAR439954)
Sotagliflozin dose 2, once daily for 8 days
Drug: Sotagliflozin (SAR439954)
Placebo, once daily for 8 days
Drug: Placebo
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Adverse events (AEs)
Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE)
Time frame: Up to 41 days
Assessment of PK parameter: Maximum plasma concentration (Cmax)
Sotagliflozin and Sotagliflozin-O-glucuronide: Maximum plasma concentration (Cmax)
Time frame: On Day 1 and from Day 8 to Day 13
Assessment of PK parameter: Area under curve from 0 to 24 hours (AUCtau)
Sotagliflozin and Sotagliflozin-O-glucuronide: Area under curve from 0 to 24 hours (AUCtau) of sotagliflozin
Time frame: On Day 1 and Day 8
Assessment of PK parameter: Area under the concentration-time curve (AUC)
Sotagliflozin and Sotagliflozin-O-glucuronide: Area under the concentration-time curve from 0 to infinity
Time frame: From Day 8 to Day 13
Assessment of PD parameter: urinary glucose excretion (UGE)
Total 24-hour urinary glucose excretion (UGE) after dose with sotagliflozin
Time frame: On Day 1 and Day 8
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sotagliflozin