Status: Ongoing First registered on: 04/06/2019
Last updated on: 03/03/2023
1. Study identification
EU PAS Register NumberEUPAS29985
Official titleCardiovascular and renal outcomes, and mortality in Danish patients with type 2 diabetes who initiate empagliflozin versus GLP1-RA: A Danish nationwide comparative effectiveness study
Study title acronymEMPLACE
Study typeOther: Cohort observational study
Brief description of the studyTo 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsAarhus University Dept. of Clinical Epidemiology
Department/Research groupAarhus University, Dept of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Website/Homepagewww.kea.au.dk
Details of (Primary) lead investigator
Title Professor
Last name Sørensen
First name Henrik Toft
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/12/201705/12/2017
Start date of data collection01/10/201801/10/2018
Start date of data analysis01/04/2019
Date of interim report, if expected
Date of final study report30/06/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Thomsen
First name Reimar W
Address line 1Aarhus University, Dept of Clinical Epidemiology
Address line 2 
Address line 3Olof Palmes Allé 43-45 
CityAarhus N 
Postcode8200 
CountryDenmark
Phone number (incl. country code)45-87168403 
Alternative phone number 
Fax number (incl. country code) 
Email address rwt@clin.au.dk
Public Enquiries
Title Dr 
Last name Thomsen 
First name Reimar W 
Address line 1Aarhus University, Dept of Clinical Epidemiology 
Address line 2 
Address line 3Olof Palmes Allé 43-45 
CityAarhus N 
Postcode8200 
CountryDenmark 
Phone number (incl. country code)45-87168403 
Alternative phone number 
Fax number (incl. country code) 
Email address rwt@clin.au.dk 
Top