PCSCVM003617/ A Real-World Database Study of Canagliflozin Utilization in Type 1 Diabetes Patients Over Time among European Countries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47809
• EU PAS number:
  EUPAS47585
• Study ID:
  47809
• Official title and acronym:
  PCSCVM003617/ A Real-World Database Study of Canagliflozin Utilization in Type 1 Diabetes Patients Over Time among European Countries
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Italy

  Spain

  United Kingdom
• Study status:
  Finalised

Research institutions and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned: 08/06/2022

Actual: 08/06/2022

Study start date

Planned: 31/03/2023

Actual: 07/03/2023

Date of final study report

Planned: 30/06/2024

Actual: 04/06/2024

Sources of funding

Other

More details on funding

Janssen R&D

Study protocol

Initial protocol

21Oct2024-REDACTED_Protocol-FD-PCSCVM003617-EUPAS47585.pdf

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)