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Sotagliflozin

Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension

Ensayo de Sanofi en Diabetes.

Más ensayos de: Diabetes.

Fase

Fase 2

Estado

Completado

Participantes

41

previstos

Centros

1

Fin del objetivo primario

abr 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2018.

Qué mide

Assessment of pharmacodynamic (PD) parameters in feces (Baseline and on Day 55 and 56 (over 48 hours)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To compare the metabolic and gastrointestinal pharmacodynamic (PD) effects of an 8 weeks treatment with sotagliflozin once daily (QD) to an 8 weeks treatment to empagliflozin QD in mild or moderate hypertensive T2DM patients on a stable treatment regimen with metformin and an angiotensin converting enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) under standardized diet conditions. Secondary Objectives: * To compare the renal and cardiovascular PD effects of an 8 weeks treatment with sotagliflozin QD to an 8 weeks treatment to empagliflozin QD in mild or moderate hypertensive T2DM patients on a stable treatment regimen with metformin and an ACE inhibitor or ARB. * To evaluate the safety and tolerability of an 8 weeks QD treatment with sotagliflozin or empagliflozin in mild to moderate hypertensive T2DM patients on a stable treatment with metformin and an ACE inhibitor or ARB. * To evaluate the pharmacokinetic (PK) profile of sotagliflozin in steady state conditions.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03462069), actualizada en abr 2022.