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NCT01778049 · ClinicalTrials.gov registry record · Phase 3

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
708
Enrollment target

NCT01778049 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 708 participants.

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The verdict

NCT01778049, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
708 participants
Enrollment target

Study Summary

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

Interventions

  • DRUG BI 10773
  • DRUG BI 10773 Placebo
  • DRUG BI 10773 / BI 1356

Trial Details

FieldValue
Enrollment Target 708 participants
Start Date 2013-01
Est. Completion 2015-03
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01778049

The ClinicalTrials.gov registry entry for NCT01778049 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 708 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 BI 10773 is the first listed.

NCT01778049 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01778049 about?

NCT01778049 is a clinical study titled "Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes". The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluat...

What is the current status of trial NCT01778049?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 708 participants. The study started on 2013-01. Estimated completion is 2015-03.

What interventions are being tested in trial NCT01778049?

The interventions under investigation include: BI 10773 (DRUG), BI 10773 Placebo (DRUG), BI 10773 / BI 1356 (DRUG).

Who is sponsoring clinical trial NCT01778049?

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.