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Clinical Trial Details

Trial ID: L3754
Source ID: NCT03462069
Associated Drug: Sotagliflozin (Sar439954)
Title: Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: Sotagliflozin (SAR439954)|DRUG: Placebo|DRUG: Empagliflozin|DRUG: Placebo
Outcome Measures: Primary: Assessment of pharmacodynamic (PD) parameters in feces, Change from baseline in fecal sodium excretion, Baseline and on Day 55 and 56 (over 48 hours)|Assessment of pharmacodynamic (PD) parameters in feces, Change from baseline in fecal short-chain fatty acids (SCFA), Baseline and on Day 55 and 56 (over 48 hours)|Assessment of pharmacodynamic (PD) parameters in feces, Change from baseline in fecal pH, Baseline and on Day 55 and 56 (over 48 hours)|Assessment of PD parameters in urine, Change from baseline in 24-hour urinary glucose excretion, Baseline and on Day 56 (over 24 hours)|Assessment of PD parameters in urine, Change from baseline in 24-hour sodium excretion, Baseline and on Day 56 (over 24 hours)|Assessment of PD parameters in blood, 14 hour plasma glucose profile after standardized meals, Baseline and on Day 56|Assessment of PD parameters in blood, 14 hour plasma glucagon-like peptide 1 (GLP-1) profile after standardized meals, Baseline and on Day 56 | Secondary: Fasting metabolic laboratory panel, Change from baseline in fasting plasma glucose, Baseline and on Day 56|Ambulatory Blood Pressure Measurement (ABPM), Change from baseline in average 24h systolic arterial pressure, Baseline and on days 54 until Day 56|Cardiovascular parameters, Change from baseline in plasma aldosterone, Baseline and on Day 56|Pulse wave velocity, Change from baseline in carotid-femoral pulse wave velocity, Baseline and on Day 55|Continuous Glucose Monitoring (CGM), Change from baseline in average diurnal glucose, Baseline, last 3 days of treatment|Echocardiography, Change from baseline in left ventricular ejection fraction (LVEF), Baseline and on Day 54|Echocardiography, Change from baseline in left ventricular end-diastolic diameter, Baseline and on Day 54|Plasma Volume Measurement, Change from baseline in plasma volume, Baseline and on Day 54|Adverse events, Number of patients with reported adverse events, Over 15 weeks|Assessment of pharmacokinetic (PK) parameters: Cmax, Sotagliflozin: maximum plasma concentration observed (Cmax), 24 hours after last investigational medicinal product (IMP) administration|Assessment of pharmacokinetic (PK) parameters: Ctrough, Sotagliflozin: plasma concentration observed before administration during repeated dosing (Ctrough), 24 hours after last IMP administration|Assessment of pharmacokinetic (PK) parameters: AUCtau, Sotagliflozin: Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (AUCtau), 24 hours after last IMP administration|Assessment of pharmacokinetic (PK) parameters: tmax, Sotagliflozin: First time to reach Cmax (tmax), 24 hours after last IMP administration
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 41
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-03-12
Completion Date: 2019-04-18
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 2760001, Berlin, 10117, Germany
URL: https://clinicaltrials.gov/show/NCT03462069