Status: Ongoing First registered on: 05/07/2016
Last updated on: 13/12/2018
1. Study identification
EU PAS Register NumberEUPAS13969
Official titleRisk of lactic acidosis associated with metformin use in patients with type 2 diabetes and moderate-severe chronic kidney disease: a case-control study
Study title acronymALIMAR-C2
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?No
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 belongsClinical Pharmacology Service, HUB/IDIBELL
Department/Research groupClinical Pharmacology Service
Organisation/affiliationBellvitge University Hospital/IDIBELL
Website/Homepagewww.bellvitgehospital.cat
Details of (Primary) lead investigator
Title Dr
Last name Pedrós
First name Consuelo
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?18

IDIAPJGol
Hospital Clinic Barcelona
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.
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/12/2015
Start date of data collection01/02/201701/02/2017
Start date of data analysis01/12/2018
Date of interim report, if expected
Date of final study report31/12/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyInstitute of Health Carlos III; Subprogramme of Health Research Projects-Strategic Action in Health 2015 (file number PI15/00764)100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Pedrós
First name Consuelo
Address line 1Servicio de Farmacología Clínica
Address line 2Hospital Universitario de Bellvitge 
Address line 3c/Feixa Llarga s/n 
CityL’Hospitalet de Llobregat 
Postcode08907 
CountrySpain
Phone number (incl. country code)34-932607220 
Alternative phone number34-932607279 
Fax number (incl. country code)34-932607223 
Email address cpedros@bellvitgehospital.cat
Public Enquiries
Title Dr 
Last name Pedrós 
First name Consuelo 
Address line 1Servicio de Farmacología Clínica 
Address line 2Hospital Universitario de Bellvitge 
Address line 3c/Feixa Llarga s/n 
CityL’Hospitalet de Llobregat 
Postcode08907 
CountrySpain 
Phone number (incl. country code)34-932607220 
Alternative phone number34-932607279 
Fax number (incl. country code)34-932607223 
Email address cpedros@bellvitgehospital.cat 
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