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NCT03387657
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
Phase 1 trial testing Sotagliflozin (SAR439954) in Type 2 Diabetes Mellitus in 16 participants. Completed in 2 March 2018.
2 March 2018
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 3 January 2018 |
| Primary completion | 2 March 2018 |
| Estimated completion | 2 March 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sotagliflozin (SAR439954) — full drug profile →
- Hydrochlorothiazide (hydrochlorothiazide) — full drug profile →
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Sanofi — full company profile →
Who can join
Adults 18 to 55, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin. Secondary Objectives: * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ * To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ * To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03387657
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- 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
- NCT03332771 — Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That A · Phase 3 · completed
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Other Sanofi trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03387657 (US National Library of Medicine, public domain)
- 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/NCT03387657.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing