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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Empagliflozin
  • DRUG GLP-1 receptor agonist
  • DRUG DPP-4 inhibitor

Study Locations (1)

Massachusetts

  • Bringham Women Hospital - Boston

Trial Details

FieldValue
Enrollment Target 230,000 participants
Start Date 2017-10-16
Est. Completion 2026-04-30

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT03363464

The ClinicalTrials.gov registry entry for NCT03363464 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 230,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 3,824-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (5915% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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