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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: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01131676 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 7,064 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (815% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented.
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
| Field | Value |
|---|---|
| Enrollment Target | 7,064 participants |
| Start Date | 2010-07 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT01131676 record still lists
NCT01131676 is an interventional study that assigns participants to a tested intervention. Its 7,064 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 (815% higher).
The record links to 0 conditions, and to 4 interventions - of which BI 10773 low dose is the first listed.
NCT01131676 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01131676's enrollment target sits among peer trials
7,064 34th of 2000 higher than 1,967 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
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