Status: Planned First registered on: 06/04/2017
Last updated on: 06/04/2017
1. Study identification
EU PAS Register NumberEUPAS18510
Official titleAssessment of cardiovascular effects of non-insulin glucose-lowering agents. Major cardiovascular events in new users of non-insulin glucose-lowering agents: observational longitudinal study in the Catalan population-based electronic health record database, SIDIAP, 2010-2015
Study title acronym
Study typeObservational study
Brief description of the studyCardiovascular (CV) risk is the leading cause of morbidity and mortality in T2DM population. The effect of control serum glucose levels on macrovascular complications remains uncertain. Glucose-lowering agents are currently marketed based on results of clinical trials with subrogate variables, mainly the percentage of glycated haemoglobin and other glucose markers. In 2007, concerns about CV safety of rosiglitazone led to regulatory recommendations regarding CV risk of new hypoglycemic agents, which are in force since 2008 (FDA, US) and 2012 (EMA, EU). In order to fulfill these recommendations, since 2008 a number of large randomized clinical trials have been designed and conducted, with a non-inferiority design as basis, with controversial results. Other ten large RCTs, on-going or recently completed, are currently assessing the CV effect of seven marketed agents are currently unavailable. Aim: To evaluate the effect of currently marketed non-insulin glucose-lowering agents on major CV outcomes in cohorts of Spanish population based on records of population-based EMR SIDIAP. Design: Longitudinal retrospective observational cohort study, period of observation of six years (1st January 2010- 31st Dec 2015) Material and Methods: Cohorts of patients aged 18 yrs. or older registered in the SIDIAP database, diagnosed of type 2 diabetes mellitus, and treated with approved glucose-lowering agents since their first prescription. Patients will be stratified by demographic and clinical variables. The incidence rate of the first major cardiovascular event will be calculated. The primary outcome (PCO) is the composite of CV death, non-fatal myocardium infarction (MI) and non-fatal stroke. Secondary outcomes are: composite (SCO) of CV death, a non-fatal myocardium infarction (MI), non-fatal stroke and hospitalization due to unstable angina or coronary revascularization procedures; individual components of SCO, hospitalization due to HF (HHF) and all-cause mortality.
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 belongsFICF
Department/Research group
Organisation/affiliationFundació Institut Català de Farmacologia
Website/Homepagewww.icf.uab.cat
Details of (Primary) lead investigator
Title Dr
Last name Vidal
First name Xavier
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

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 signed01/07/2016
Start date of data collection01/09/2016
Start date of data analysis01/03/2017
Date of interim report, if expected
Date of final study report01/03/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
CharitiesIDIAP Jordi Gol100
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Vidal
First name Xavier
Address line 1Vall d'Hebron 119-129
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08035 
CountrySpain
Phone number (incl. country code)34934894106 
Alternative phone number 
Fax number (incl. country code) 
Email address xvg@icf.uab.cat
Public Enquiries
Title Dr 
Last name Vidal 
First name Xavier 
Address line 1Vall d'Hebron 119-129 
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08035 
CountrySpain 
Phone number (incl. country code)34934894106 
Alternative phone number 
Fax number (incl. country code) 
Email address xvg@icf.uab.cat 
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