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

Sponsor
Sanofi
Study ID
NCT03462069
Phase
PHASE2
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Sotagliflozin (SAR439954) — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • Placebo — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • Empagliflozin — DRUG
    Pharmaceutical form: capsule Route of administration: oral
  • Placebo — DRUG
    Pharmaceutical form: capsule Route of administration: oral

Study Details

Primary 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.

Key Dates

Start date
Mar 12, 2018
Status verified
Apr 2022
Primary completion
Apr 18, 2019
Completion
Apr 18, 2019

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A (Test)
    Sotagliflozin 2 tablets administered once daily with 1 empagliflozin placebo capsule prior to the first meal of the day
  • Active Comparator: Treatment B (Reference)
    Empagliflozin 1 capsule administered once daily with 2 sotagliflozin placebo tablets prior to the first meal of the day

Primary Outcome Measure

Assessment of pharmacodynamic (PD) parameters in feces [ Time Frame: Baseline and on Day 55 and 56 (over 48 hours) ]

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