Study identification

EU PAS number

EUPAS18510

Study ID

18511

Official title and acronym

Assessment 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

DARWIN EU® study

No

Study countries

Spain

Study description

Cardiovascular (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.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Xavier Vidal

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Non-for-profit organisation (e.g. charity)

More details on funding

IDIAP Jordi Gol
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable