Study identification

PURI

https://redirect.ema.europa.eu/resource/26994

EU PAS number

EUPAS13969

Study ID

26994

Official title and acronym

Risk of lactic acidosis associated with metformin use in patients with type 2 diabetes and moderate-severe chronic kidney disease: a case-control study (ALIMAR-C2)

DARWIN EU® study

No

Study countries

Spain

Study description

The use of metformin in patients with type 2 diabetes (2D) is rarely associated with lactic acidosis (LA) provided that contraindications do not exist. Though the safety information available in patients with moderate-severe chronic kidney disease (CKD) is limited and inconclusive, the use of metformin in this population is wide. This is a case-control study to assess the association between metformin and LA in patients with 2DM and moderate-severe CKD. It will be performed with computerized registered data from 16 Spanish hospitals and their areas of influence in primary care from 2010 to 2015, comprising more than 50 million person-years follow-up. Logistic regression will be used to assess the crude and adjusted risk of LA associated to metformin use overall and stratifying by use and dose categories and CKD stage. The overall case fatality rate of LA as well as the case fatality rate stratified by CKD stage will be calculated. Observation bias will also be explored.

Study status

Ongoing
Research institution and networks

Institutions

IDIBELL
Hospital La Paz
First published:
01/02/2024
Institution
Hospital Vall d’Hebron,Hospital Germans Trias i Pujol,Hospital de La Santa Creu i Sant Pau. Barcelona, Spain. Fundación Jiménez Díaz,Hospital Universitario Puerta de Hierro,Hospital Ramón y Cajal,Servicio Madrileño de la Salud,Hospital La Paz,Hospital Clínico San Carlos Madrid, Spain. Hospital Universitario Virgen del Rocío Sevilla, Spain. Hospital Universitario Reina Sofía Córdoba, Spain. Hospital Universitario Virgen de la Victoria y Regional de Málaga Málaga, Spain. Hospital Universitario de Cruces Barakaldo,Spain. Hospital Universitario Donostia San Sebastián, Spain. Hospital Universitario de Canarias Tenerife, Spain.

Contact details

Consuelo Pedrós

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Institute of Health Carlos III, Subprogramme of Health Research Projects-Strategic Action in Health 2015 (file number PI15/00764)
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable