Safety Evaluation of Adverse Reactions in Diabetes - Drug utilisation studies (SAFEGUARD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20761
• EU PAS number:
  EUPAS4364
• Study ID:
  20761
• Official title and acronym:
  Safety Evaluation of Adverse Reactions in Diabetes - Drug utilisation studies (SAFEGUARD)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Netherlands

  Spain

  United Kingdom

  United States
• Study description:
  The safety of pharmacological treatments used in type 2 diabetes is an ongoing concern. Associations between drugs such as rosiglitazone, pioglitazone and exenatide and adverse cardiovascular, urinary and pancreatic health outcomes have all been suggested in the last decade. Assessments of these associations have been complicated by the complex, often heterogeneous nature of type 2 diabetes treatment and by the strong link between severity of diabetes and/or non-response to treatment and changes in treatment. In a number of countries, information on both prescribing and/or dispensing of these medications and the adverse health outcomes potentially associated with them is routinely collected in electronic healthcare databases. Work package 4 of the FP7 funded Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD) project seeks to utilize such databases to assess the safety of type 2 diabetes treatments. The primary objective of the SAFEGUARD Drug Utilisation Study (DUS) is to describe the use of non-insulin blood glucose lowering agents, insulin and insulin analogues in the data sources involved in SAFEGUARD. Utilisation will be described at a population, patient and prescription level and results will be presented stratified across a range of patient characteristics and other covariates. The results will provide information on the utilisation of type 2 diabetes drugs across six countries and will be used to inform exposure assessment and control of confounding in SAFEGUARD studies assessing the safety of drugs used in type 2 diabetes.
• Study status:
  Finalised

Research institutions and networks

Institutions

Erasmus Medical Centre Rotterdam

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

Società Italiana di Medicina Generale e delle Cure Primarie (SIMG)

University of Bath

AEMPS Spain, UNIMIB Italy, BWH United States of America

Study timelines

Date when funding contract was signed

Planned: 23/08/2011

Actual: 23/08/2013

Study start date

Planned: 26/07/2013

Actual: 26/07/2013

Data analysis start date

Planned: 01/09/2013

Actual: 05/09/2013

Date of final study report

Planned: 30/09/2015

Actual: 25/08/2017

Sources of funding

EU institutional research programme

More details on funding

Health Area of the European Commission under the VII Framework Programme

Study protocol

Initial protocol

Safety Evaluation of Adverse Reactions In Diabetes - Drug Utilisation Study

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable