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NCT01167881 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
1,549
Enrollment target

NCT01167881 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,549 participants.

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The verdict

NCT01167881, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
1,549 participants
Enrollment target

Study Summary

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Interventions

  • DRUG Placebo
  • DRUG Glimepiride
  • DRUG BI 10773

Trial Details

FieldValue
Enrollment Target 1,549 participants
Start Date 2010-08
Est. Completion 2015-08
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01167881

The ClinicalTrials.gov registry entry for NCT01167881 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,549 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 3 interventions - of which Placebo is the first listed.

NCT01167881 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01167881 about?

NCT01167881 is a clinical study titled "Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes". This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

What is the current status of trial NCT01167881?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,549 participants. The study started on 2010-08. Estimated completion is 2015-08.

What interventions are being tested in trial NCT01167881?

The interventions under investigation include: Placebo (DRUG), Glimepiride (DRUG), BI 10773 (DRUG).

Who is sponsoring clinical trial NCT01167881?

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.