Empagliflozin effectiveness in a real-world population replicating the DECLARE - TIMI58 trial

Study identification

• EU PAS number:
  EUPAS26481
• Study ID:
  32643
• Official title and acronym:
  Empagliflozin effectiveness in a real-world population replicating the DECLARE - TIMI58 trial
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study aims to evaluate the effect of empagliflozin on cardiovascular events and mortality in a real-world population aligned with the trial population, e.g., inclusion and exclusion criteria, of the Dapagliflozin Effect on Cardiovascular Events (DECLARE) - TIMI58 cardiovascular outcome trial using real-world data. This study will produce results on the effect of empagliflozin on cardiovascular events and mortality, which will be directly comparable to the results for dapagliflozin from the DECLARE - TIMI58 trial.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Brigham and Women's Hospital

Study timelines

Date when funding contract was signed

Planned:06/11/2018

Actual:06/11/2018

Study start date

Planned:07/11/2018

Actual:07/11/2018

Date of final study report

Planned:31/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable