Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03315143 · ClinicalTrials.gov registry record · Phase 3
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 10,584
- Enrollment target
NCT03315143: Clinical Trial Phase 3 study, sponsored by Lexicon Pharmaceuticals.
NCT03315143 is a Phase 3 study that was terminated before completion, run by Lexicon Pharmaceuticals. The registered enrollment target is 10,584 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1273% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03315143, a Phase 3 study, was terminated before completion, sponsored by Lexicon Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 10,584 participants
- Enrollment target
Study Summary
The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure \[HHF\], and urgent visit for heart failure \[HF\] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.
Primary Outcome
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,584 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2020-07-08 |
| Phase | Phase 3 |
Why NCT03315143 stopped before completion
NCT03315143 is an interventional study that assigns participants to a tested intervention. Its 10,584 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1273% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03315143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03315143 about?
NCT03315143 is a clinical study titled "Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk". The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure \[HHF\], and urgent visit for heart failure \[HF\] in participants with type 2 diabetes, cardiovascular risk factors, and mode...
What is the current status of trial NCT03315143?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 10,584 participants. The study started on 2017-12-19. Estimated completion is 2020-07-08.
What interventions are being tested in trial NCT03315143?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT03315143?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03315143's enrollment target sits among peer trials
10,584 25th of 2000 higher than 1,976 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06081517 · 10,600 participants
Evaluating Disparities in Precision Oncology
- NCT05759299 · 10,500 participants
International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia
- NCT06891222 · 10,500 participants
A Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening
- NCT07157774 · 10,450 participants · Phase 3
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI