Study identification

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

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
AEMPS Spain, UNIMIB Italy, BWH United States of America

Contact details

Miriam Sturkenboom

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EU institutional research programme

More details on funding

Health Area of the European Commission under the VII Framework Programme
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable