Study identification

EU PAS number

EUPAS1000000662

Study ID

1000000662

Official title and acronym

DARWIN EU® - Characterisation of acute renal outcomes and diabetic complications among patients with concomitant use of metformin and iodinated contrast agents

DARWIN EU® study

Yes

Study countries

Denmark
Finland
Spain
United Kingdom

Study description

Art.31 CHMP referral in 2016 on metformin and use in patients with reduced kidney function led to PI updates including introduction of a warning and interaction with concomitant use with iodinated agents for patients undergoing imaging procedures.
Based on the evidence reviewed in the PSUSA, it was considered premature to delete the warning and interaction in the metformin PIs, at this stage. PRAC suggested the possibility to conduct a RWD study to gather more data on this specific issue and understand better if further regulatory action would be deemed necessary

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Wanning Wang

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable