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)

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

Bellvitge University Hospital

IDIBELL

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Clinical Pharmacology Department, UASP Hospital Universitario Clinic Barcelona

Spain

University Hospital Vall d’Hebron (HUVH)

Spain

Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau – IIB Sant Pau

Puerta de Hierro-Majadahonda University Hospital

Hospital La Paz

Hospital Clinico San Carlos

Hospital Universitario Virgen del Rocío

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.

Study timelines

Date when funding contract was signed

Planned: 16/12/2015

Study start date

Planned: 01/02/2017

Actual: 01/02/2017

Data analysis start date

Planned: 01/12/2018

Date of final study report

Planned: 31/12/2019

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