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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 is a Phase 3 study that was terminated before completion, run by Lexicon Pharmaceuticals. The registered enrollment target is 10,584 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Sotagliflozin

Trial Details

FieldValue
Enrollment Target 10,584 participants
Start Date 2017-12-19
Est. Completion 2020-07-08
Phase Phase 3

Sponsor

Lexicon Pharmaceuticals

56 total trials

What the Registry Record Tells You About NCT03315143

The ClinicalTrials.gov registry entry for NCT03315143 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 10,584 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03315143 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.