Monitoring of Compliance with Exenatide Prescribing Guidelines in Canada: Drug Utilisation Study of BYETTA in Canada for 2011-2014

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19058
• EU PAS number:
  EUPAS17963
• Study ID:
  19058
• Official title and acronym:
  Monitoring of Compliance with Exenatide Prescribing Guidelines in Canada: Drug Utilisation Study of BYETTA in Canada for 2011-2014
• DARWIN EU® study:
  No
• Study countries:
  Canada
• Study description:
  This was a retrospective cohort study conducted to evaluate adherence to the labelling recommendations for BYETTA use in Canada. Data from the Canadian IMS Brogan’s Longitudinal Patient Data assets (LRx) for 2011-2014 was used.
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 20/01/2011

Actual: 20/01/2011

Study start date

Planned: 01/06/2011

Actual: 01/06/2011

Data analysis start date

Planned: 01/07/2014

Actual: 01/07/2014

Date of final study report

Planned: 25/03/2015

Actual: 25/03/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca Canada

Study protocol

Initial protocol

D5550N00008_Protocol

Regulatory

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

Other study registration identification numbers and links

D5550N00008