Study identification

PURI

https://redirect.ema.europa.eu/resource/44917

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

Ongoing
Research institution and networks

Institutions

Aarhus University Hospital

Contact details

Henrik Toft Sørensen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim
Study protocol
Initial protocol

RWE Empa and Lira

English (909.98 KB - PDF)View document
Updated protocol

emplace-nis-study-protocol-version-03

English (359.73 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable