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NCT02531035 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

A Phase 3 study, sponsored by Lexicon Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,405
Enrollment target

NCT02531035 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 1,405 participants.

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The verdict

NCT02531035, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,405 participants
Enrollment target

Study Summary

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Interventions

  • DRUG Placebo
  • DRUG Sotagliflozin

Trial Details

FieldValue
Enrollment Target 1,405 participants
Start Date 2015-09
Est. Completion 2017-04
Phase Phase 3

Sponsor

Lexicon Pharmaceuticals

56 total trials

What the Registry Record Tells You About NCT02531035

The ClinicalTrials.gov registry entry for NCT02531035 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,405 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.

NCT02531035 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02531035 about?

NCT02531035 is a clinical study titled "A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone". This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

What is the current status of trial NCT02531035?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,405 participants. The study started on 2015-09. Estimated completion is 2017-04.

What interventions are being tested in trial NCT02531035?

The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).

Who is sponsoring clinical trial NCT02531035?

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.