Status: Finalised First registered on: 22/08/2013
Last updated on: 25/08/2017
1. Study identification
EU PAS Register NumberEUPAS4364
Official titleSafety Evaluation of Adverse Reactions in Diabetes - Drug utilisation studies
Study title acronymSAFEGUARD
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?Yes: EMA
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 belongsErasmus MC Pharmacoepi
Department/Research groupPharmacoepidemiology Erasmus University
Organisation/affiliationErasmus University Medical Center
Website/Homepagewww.erasmusmc.nl
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
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?10

PHARMO Institute
CMNS
BIPS GmbH
University of Bath
RTI-HS
Health Search-SIMG
Erasmus MC Pharmacoepi
AEMPS, Spain
UNIMIB, Italy
BWH, United States of America
Countries in which this study is being conducted
International study

Germany
Italy
Netherlands
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed23/08/201123/08/2013
Start date of data collection26/07/201326/07/2013
Start date of data analysis01/09/201305/09/2013
Date of interim report, if expected
Date of final study report30/09/201525/08/2017
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 body
Research councils
EU funding scheme
OtherHealth Area of the European Commission under the VII Framework Programme100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1POBOX 2040
Address line 2dep. Medical Informatics 
Address line 3 
CityRotterdam 
Postcode3000 CA 
CountryNetherlands
Phone number (incl. country code)31-10-7044123 
Alternative phone number 
Fax number (incl. country code) 
Email address m.sturkenboom@erasmusmc.nl
Public Enquiries
Title Professor 
Last name Sturkenboom 
First name Miriam 
Address line 1POBOX 2040 
Address line 2dep. Medical Informatics 
Address line 3 
CityRotterdam 
Postcode3000 CA 
CountryNetherlands 
Phone number (incl. country code)31-10-7044123 
Alternative phone number 
Fax number (incl. country code) 
Email address m.sturkenboom@erasmusmc.nl 
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