Cardiovascular and renal outcomes, and mortality in Danish patients with type 2 diabetes who initiate empagliflozin versus GLP1-RA: A Danish nationwide comparative effectiveness study (EMPLACE)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS29985
• Study ID:
  44917
• Official title and acronym:
  Cardiovascular and renal outcomes, and mortality in Danish patients with type 2 diabetes who initiate empagliflozin versus GLP1-RA: A Danish nationwide comparative effectiveness study (EMPLACE)
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  To compare, among patients with type 2 diabetes in Denmark, clinical outcomes among new users (initiators) of empagliflozin versus GLP1-RA. Our primary objective is to compare clinical outcomes (cardiovascular and renal outcomes and mortality) among empagliflozin initiators versus liraglutide and other GLP1-RA initiators in Denmark. This is a non-interventional cohort study using existing data. The study will use a new user design and compare new users of empagliflozin with new users of GLP1-RA. The study population will include all eligible patients with type 2 diabetes initiating treatment with empagliflozin or with GLP1-RA between 2015 and until 2020 or the latest date of data availability.
• Study status:
  Finalised

Research institutions and networks

Institutions

Aarhus University

Aarhus University Hospital

Study timelines

Date when funding contract was signed

Planned:05/12/2017

Actual:05/12/2017

Study start date

Planned:01/10/2018

Actual:01/10/2018

Data analysis start date

Planned:01/04/2019

Date of final study report

Planned:31/01/2023

Actual:31/05/2023

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

Other study registration identification numbers and links

1245-0194
NCT03993132