Status: Finalised First registered on: 26/11/2013
Last updated on: 03/05/2021
1. Study identification
EU PAS Register NumberEUPAS5249
Official titleMetformin use in renal impairment
Study title acronym
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?Yes: EMA
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 groupDepartment of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
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?
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2
Boston Collaborative Drug Surveillance Program, Boston, USA
Countries in which this study is being conducted
International study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
Date when funding contract was signed31/07/201331/07/2013
Start date of data collection16/12/201316/12/2013
Start date of data analysis16/12/201316/12/2013
Date of interim report, if expected31/03/201430/04/2014
Date of final study report30/06/201430/06/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ehrenstein
First name Vera
Address line 1Dept of Clinical Epidemiology
Address line 2Aarhus University Hospital 
Address line 3Olof Palmes Alle 43-45 
CityAarhus N 
Phone number (incl. country code)49-17663169720 
Alternative phone number 
Fax number (incl. country code) 
Email address
Public Enquiries
Title Professor 
Last name Sørensen 
First name Henrik Toft 
Address line 1Olof Palmes Allé 43-45 
Address line 2 
Address line 3 
CityAarhus N 
Phone number (incl. country code)45-87168063 
Alternative phone number 
Fax number (incl. country code)45-87167215 
Email address