Metformin use in renal impairment

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40847
• EU PAS number:
  EUPAS5249
• Study ID:
  40847
• Official title and acronym:
  Metformin use in renal impairment
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  United Kingdom
• Study status:
  Finalised

Research institution and networks

Institutions

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Boston Collaborative Drug Surveillance Program Boston, USA

Study timelines

Date when funding contract was signed

Planned: 31/07/2013

Actual: 31/07/2013

Study start date

Planned: 16/12/2013

Actual: 16/12/2013

Data analysis start date

Planned: 16/12/2013

Actual: 16/12/2013

Date of interim report, if expected

Planned: 31/03/2014

Actual: 30/04/2014

Date of final study report

Planned: 30/06/2014

Actual: 30/06/2014

Sources of funding

EMA

Study protocol

Initial protocol

Metformin use in renal impairment Final Protocol 2013-10-31

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable