Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD)

At a Glance
  • Status: Active Consortium
  • Year Launched: 2011
  • Initiating Organization: European Commission Seventh Framework Programme (FP7)
  • Initiator Type: Government
  • Disease focus:
    Type 2 Diabetes
  • Location: Europe


The primary aim of the Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD) consortium is to assess and further quantify and understand the cardio/cerebrovascular and pancreatic safety of blood glucose–lowering agents, in particular the thiazolidinediones (TZDs) and the novel incretin-based drugs and amylin analogs in Type 2 diabetes mellitus (T2DM) patients. The SAFEGUARD consortium is formed by a multidisciplinary group including diabetes experts, clinicians, pharmacologists, pharmacovigilance experts, statisticians, and pharmacoepidemiologists, and it will capitalize on knowledge generated in other European Union (EU)–funded projects to create a harmonized data platform. This platform will allow for the largest scale studies on T2DM drugs developed so far as well as for the implementation of new epidemiological studies.


The SAFEGUARD studies include the following:

Consortium History

Oct. 1, 2011: Project started
Sept. 30, 2015: Project ended

Structure & Governance

SAFEGUARD’s work is divided into the following Work Packages (WPs):
WP1 and WP2 provide scientific leadership and operational management to project research. WP3 to WP7 are the main knowledge-generating and scientific work packages, and each deals with different data substrates:


The funding scheme is through the European Union’s Seventh Framework Programme (small or medium-scale focused research project). The project cost is €3.9 million. Funding is €3.0 million.

Points of Contact

Scientific Coordinator:
Miriam Sturkenboom
Department of Medical Informatics
Erasmus University Medical Center


Project Manager:
Mireia Manent
Synapse Research Management Partners S.L.



Sponsors & Partners

Agencia Espanola de Medicamentos y Productos Sanitarios

BIPS Institut fur Epidemiologie und Praventionsforschung GmbhH

Consorzio Mario Negri Sud

Drug Safety Research Trust

Erasmus Medical Center

Fondaziones Scientifica SIMG-ONLUS

PHARMO Institute N.V.

RTI Health Solutions

Stichting VU-VUMC

Synapse Research Management Partners

The Brigham and Women’s Hospital, Harvard Medical School

Universitaet Bremen

University of Bath

University of Milano - Bicocca

Univerzita Karlova v Praze

Last Updated: 04/15/2016

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