A Randomized, Double-blind, Parallel-group, 2-treatment Multiple Dose Study to Assess the Intestinal, Metabolic and Cardiovascular Effects of an 8 Weeks Treatment With Sotagliflozin QD as Compared With Empagliflozin Once a Day (QD) in Type 2 Diabetes Mellitus (T2DM) Patients With Mild to Moderate Hypertension
Abstract
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.
Conditions: Diabetes Mellitus.
Primary outcome: Assessment of pharmacodynamic (PD) parameters in feces; Assessment of pharmacodynamic (PD) parameters in feces; Assessment of pharmacodynamic (PD) parameters in feces; Assessment of PD parameters in urine; Assessment of PD parameters in urine; Assessment of PD parameters in blood; Assessment of PD parameters in blood.
Enrollment: 41 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 41 participants or records.
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