Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Phase 3 study, sponsored by Boehringer Ingelheim.

NCT01167881 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,549 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (101% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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
Boehringer Ingelheim

515 total trials

What the finished NCT01167881 record still lists

NCT01167881 is an interventional study that assigns participants to a tested intervention. Its 1,549 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (101% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01167881 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01167881's enrollment target sits among peer trials

1,549 150th of 2000 higher than 1,851 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02650622 · 1,550 participants

    Genetic and Metabolic Disease in Children

  • NCT03961945 · 1,550 participants · NA

    Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma

  • NCT06729775 · 1,546 participants · NA

    Disentangling the Role of Culture, Life Stage, and Information Design to Facilitate Equity in Data Report Back

  • NCT03435796 · 1,541 participants · Phase 2

    Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01167881, the US trial registry maintained by the National Library of Medicine. NCT01167881 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.