Trial · NCT03462069
Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension
NCT03462069, Phase 2, Completed, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension. Trials, record NCT03462069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03462069
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension
- NCT number
- NCT03462069
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Diabetes Mellitus
- Interventions
- Sotagliflozin (SAR439954), Placebo, Empagliflozin, Placebo
- First posted
- 2018-03-12
- Last updated
- 2022-04-25
- Other registries' IDs
- eudract:2017-002309-36
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35817022 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03462069
GET https://conductscience.org/api/trials/v1/NCT03462069/registered