Study identification

EU PAS number

EUPAS5599

Study ID

32333

Official title and acronym

AN 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

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This 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

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Saad Shakir

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis 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 &Co (36%), AstraZeneca (64%)
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)