Trial · NCT03761134
Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea
NCT03761134, Phase 3, Terminated, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea. Trials, record NCT03761134. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03761134
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea
- NCT number
- NCT03761134
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 377 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- sotagliflozin (SAR439954), placebo, metformin, sulfonylurea
- First posted
- 2018-12-03
- Last updated
- 2022-04-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in hemoglobin A1c (HbA1c) | Baseline to Week 24 | Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 1) |
| Secondary | Change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT) | Baseline to Week 24 | Absolute change from baseline to week 24 in 2-hour PPG following a MMTT (for sotagliflozin dose1 and 2) |
| Secondary | Change in fasting plasma glucose (FPG) | Baseline to Week 24 | Absolute change from baseline to week 24 in FPG (for sotagliflozin dose 1 and 2) |
| Secondary | Change in body weight | Baseline to Week 24 | Absolute change from baseline to week 24 in body weight (for sotagliflozin dose1 and 2) |
| Secondary | Change in HbA1c | Baseline to Week 24 | Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 2) |
| Secondary | Change in systolic blood pressure (SBP) for all patients | Baseline to Week 12 | Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose 1 and 2) |
| Secondary | Change in SBP for patients with baseline SBP ≥130 mmHg | Baseline to Week 12 | Absolute change from baseline to week 12 in SBP for patients with baseline SBP ≥130 mmHg (for sotagliflozin dose 1 and 2) |
| Secondary | Adverse events | Up to Week 24 | Number of patients with adverse events |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03761134
GET https://conductscience.org/api/trials/v1/NCT03761134/registered