Status: Finalised First registered on: 29/07/2016
Last updated on: 11/11/2021
1. Study identification
EU PAS Register NumberEUPAS14445
Official titleDulaglutide Modified-Prescription-Event Monitoring Study and network database study: a multi-database collaborative research program of observational studies to monitor the utilisation and safety of dulaglutide in the EU
Study title acronym
Study typeObservational study
Brief description of the studyDulaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) indicated for the treatment of patients with type 2 diabetes mellitus (T2DM). This targeted surveillance study will be conducted in order to monitor the occurrence of certain medical conditions in patients using dulaglutide in the EU. The study will quantify the occurrence and describe the characteristics of these conditions during the first 12 months after starting dulaglutide. The conditions being monitored include acute pancreatitis, hypersensitivity, pancreatic and thyroid cancers, cardiac conduction abnormalities, gastrointestinal effects, and medication errors. Additionally, for subpopulations receiving dulaglutide where safety data are usually classified as “missing information,” the distribution of these medical conditions will be described to determine if there are any differences compared to what is known for the target population. In order to assess the safety profile and utilisation of dulaglutide in the EU, a multi-database post-authorisation safety study (PASS) program will be administered by the DSRU. The DSRU will conduct a Modified Prescription-Event Monitoring (M-PEM) study in England, and it will coordinate a multi-country collaborative research program to address common aims and objectives, using existing data from three European electronic health record (EHR) databases. Each country will independently conduct an observational study developed in accordance with aims and objectives from an agreed base protocol.
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
Multiple centres

In total how many centres are involved in this Study?4

University of Messina
PHARMO Institute
BIPS GmbH
Countries in which this study is being conducted
International study

Germany
Italy
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/12/201514/12/2015
Start date of data collection01/01/201501/01/2015
Start date of data analysis
Date of interim report, if expected01/08/201728/02/2018
Date of final study report31/03/202019/04/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lynn
First name Elizabeth
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 elizabeth.lynn@dsru.org
Public Enquiries
Title Dr 
Last name Lynn 
First name Elizabeth 
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 elizabeth.lynn@dsru.org 
Top