Utilisation of dulaglutide in European countries: A cross-sectional, multi-country and multi-source drug utilisation study using electronic health record databases (H9X-MC-B010)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37875
• EU PAS number:
  EUPAS13783
• Study ID:
  37875
• Official title and acronym:
  Utilisation of dulaglutide in European countries: A cross-sectional, multi-country and multi-source drug utilisation study using electronic health record databases (H9X-MC-B010)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  Sweden

  United Kingdom
• Study description:
  This study describes the frequency of dulaglutide use in different groups of patients in European countries, including the characterization of use by demographics, main comorbidities and comedications, overall and in subgroups of interest, including patients with specific diseases, children and adolescents, the elderly, and pregnant and breastfeeding women. Additionally, medication errors and off-label use will be described among patients using dulaglutide.
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 15/12/2014

Actual: 15/12/2014

Study start date

Planned: 13/06/2016

Actual: 13/06/2016

Date of final study report

Planned: 16/12/2019

Actual: 14/11/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

H9X-MC-B010_EU-PAS-Registered

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)