Trial · NCT03462069
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of pharmacodynamic (PD) parameters in feces | Baseline and on Day 55 and 56 (over 48 hours) | Change from baseline in fecal sodium excretion |
| Primary | Assessment of pharmacodynamic (PD) parameters in feces | Baseline and on Day 55 and 56 (over 48 hours) | Change from baseline in fecal short-chain fatty acids (SCFA) |
| Primary | Assessment of pharmacodynamic (PD) parameters in feces | Baseline and on Day 55 and 56 (over 48 hours) | Change from baseline in fecal pH |
| Primary | Assessment of PD parameters in urine | Baseline and on Day 56 (over 24 hours) | Change from baseline in 24-hour urinary glucose excretion |
| Primary | Assessment of PD parameters in urine | Baseline and on Day 56 (over 24 hours) | Change from baseline in 24-hour sodium excretion |
| Primary | Assessment of PD parameters in blood | Baseline and on Day 56 | 14 hour plasma glucose profile after standardized meals |
| Primary | Assessment of PD parameters in blood | Baseline and on Day 56 | 14 hour plasma glucagon-like peptide 1 (GLP-1) profile after standardized meals |
| Secondary | Fasting metabolic laboratory panel | Baseline and on Day 56 | Change from baseline in fasting plasma glucose |
| Secondary | Ambulatory Blood Pressure Measurement (ABPM) | Baseline and on days 54 until Day 56 | Change from baseline in average 24h systolic arterial pressure |
| Secondary | Cardiovascular parameters | Baseline and on Day 56 | Change from baseline in plasma aldosterone |
| Secondary | Pulse wave velocity | Baseline and on Day 55 | Change from baseline in carotid-femoral pulse wave velocity |
| Secondary | Continuous Glucose Monitoring (CGM) | Baseline, last 3 days of treatment | Change from baseline in average diurnal glucose |
| Secondary | Echocardiography | Baseline and on Day 54 | Change from baseline in left ventricular ejection fraction (LVEF) |
| Secondary | Echocardiography | Baseline and on Day 54 | Change from baseline in left ventricular end-diastolic diameter |
| Secondary | Plasma Volume Measurement | Baseline and on Day 54 | Change from baseline in plasma volume |
| Secondary | Adverse events | Over 15 weeks | Number of patients with reported adverse events |
| Secondary | Assessment of pharmacokinetic (PK) parameters: Cmax | 24 hours after last investigational medicinal product (IMP) administration | Sotagliflozin: maximum plasma concentration observed (Cmax) |
| Secondary | Assessment of pharmacokinetic (PK) parameters: Ctrough | 24 hours after last IMP administration | Sotagliflozin: plasma concentration observed before administration during repeated dosing (Ctrough) |
| Secondary | Assessment of pharmacokinetic (PK) parameters: AUCtau | 24 hours after last IMP administration | Sotagliflozin: Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (AUCtau) |
| Secondary | Assessment of pharmacokinetic (PK) parameters: tmax | 24 hours after last IMP administration | Sotagliflozin: First time to reach Cmax (tmax) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03462069/registered