Dulaglutide 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 identification

• EU PAS number:
  EUPAS14445
• Study ID:
  44227
• Official title and acronym:
  Dulaglutide 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
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Netherlands

  United Kingdom
• Study description:
  Dulaglutide 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina

Italy

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Study timelines

Date when funding contract was signed

Planned:14/12/2015

Actual:14/12/2015

Study start date

Planned:01/01/2015

Actual:01/01/2015

Date of interim report, if expected

Planned:01/08/2017

Actual:28/02/2018

Date of final study report

Planned:31/03/2020

Actual:19/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)