Study identification

PURI

https://redirect.ema.europa.eu/resource/44227

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

Contact details

Saad Shakir

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly
Study protocol
Initial protocol

Dulaglutide MPEM and network study protocol abstract for EUPAS Register

English (111.34 KB - PDF)View document
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)