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NCT03363464 · ClinicalTrials.gov registry record
Comparative Effectiveness of Empagliflozin in the US
A clinical trial of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- 230,000
- Enrollment target
- 1
- Study location
NCT03363464: Active study of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
NCT03363464 is a study of Diabetes Mellitus, Type 2 that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 230,000 participants, above the 3,824-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (5915% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03363464, a study of Diabetes Mellitus, Type 2, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- 230,000 participants
- Enrollment target
- 1
- Study location
Study Summary
Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality. However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.
Primary Outcome
i.e., non-fatal myocardial infarction (MI), non-fatal stroke, or cardiovascular (CV) mortality; as well as each individual component: * Hospital admission for MI (for purposes of this individual component, fatal MI is included) * Hospital admission for stroke (for purposes of this individual component, fatal stroke is included) * CV mortality
Conditions Studied
Interventions
- DRUG Empagliflozin
- DRUG GLP-1 receptor agonist
- DRUG DPP-4 inhibitor
Study Locations (1)
Massachusetts
- Bringham Women Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230,000 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2026-04-30 |
What the registry record for NCT03363464 still lists
NCT03363464 is an observational study that tracks outcomes without assigning an intervention. Its 230,000 participants enrollment target places it among the larger protocols in the corpus, above the 3,824-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (5915% higher).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Empagliflozin is the first listed.
NCT03363464 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03363464 about?
NCT03363464 is a clinical study titled "Comparative Effectiveness of Empagliflozin in the US". Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk ...
What is the current status of trial NCT03363464?
This trial is currently active not recruiting. The enrollment target is 230,000 participants. The study started on 2017-10-16. Estimated completion is 2026-04-30.
What conditions does trial NCT03363464 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT03363464?
The interventions under investigation include: Empagliflozin (DRUG), GLP-1 receptor agonist (DRUG), DPP-4 inhibitor (DRUG).
Who is sponsoring clinical trial NCT03363464?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03363464 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03363464's enrollment target sits among peer trials
230,000 2nd of 348 the highest of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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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