Status: Finalised First registered on: 21/01/2014
Last updated on: 15/11/2019
1. Study identification
EU PAS Register NumberEUPAS5599
Official titleAN OBSERVATIONAL POST-AUTHORIZATION MODIFIED PRESCRIPTION-EVENT MONITORING SAFETY STUDY TO MONITOR THE SAFETY AND UTILIZATION OF EXENATIDE ONCE WEEKLY (BYDUREON®) IN THE PRIMARY CARE SETTING IN ENGLAND
Study title acronym
Study typeObservational study
Brief description of the studyThis post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of exenatide (Bydureon®) is to be carried out as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of Bydureon® in clinical practice. The aim of this study is to proactively capture safety and drug utilisation data in the post-marketing phase of license approval of Bydureon® as prescribed to patients by general practitioners in England. This M-PEM study will enable the systematic collection and reporting of drug utilisation and safety data on patients newly initiated on treatment with exenatide once weekly in the primary care setting. The study aims to collect exposure and outcome data for a cohort of approximately 5000 evaluable patients
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
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 belongsDSRU
Department/Research group
Organisation/affiliationDrug Safety Research Unit
Website/Homepagewww.dsru.org
Details of (Primary) lead investigator
Title Professor
Last name Shakir
First name Saad
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed23/02/2012
Start date of data collection02/09/201101/09/2011
Start date of data analysis02/04/201801/05/2018
Date of interim report, if expected01/12/201501/12/2015
Date of final study report01/11/201821/12/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly &Co 36%, AstraZeneca 64%100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Shakir
First name Saad
Address line 1DSRU
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address saad.shakir@dsru.org
Public Enquiries
Title Professor 
Last name Shakir 
First name Saad 
Address line 1DSRU 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address saad.shakir@dsru.org 
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