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NCT01131676 · ClinicalTrials.gov registry record · Phase 3

BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
7,064
Enrollment target

NCT01131676 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 7,064 participants.

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The verdict

NCT01131676, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
7,064 participants
Enrollment target

Study Summary

The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

Interventions

  • DRUG BI 10773 low dose
  • DRUG BI 10773 high dose
  • DRUG Placebo BI 10773 high dose
  • DRUG Placebo BI 10773 low dose

Trial Details

FieldValue
Enrollment Target 7,064 participants
Start Date 2010-07
Est. Completion 2015-04
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01131676

The ClinicalTrials.gov registry entry for NCT01131676 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 7,064 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which BI 10773 low dose is the first listed.

NCT01131676 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01131676 about?

NCT01131676 is a clinical study titled "BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).". The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

What is the current status of trial NCT01131676?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,064 participants. The study started on 2010-07. Estimated completion is 2015-04.

What interventions are being tested in trial NCT01131676?

The interventions under investigation include: BI 10773 low dose (DRUG), BI 10773 high dose (DRUG), Placebo BI 10773 high dose (DRUG), Placebo BI 10773 low dose (DRUG).

Who is sponsoring clinical trial NCT01131676?

This trial is sponsored by Boehringer Ingelheim, which has 515 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.