A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE® (empagliflozin 10mg, 25mg) in Korean patients with type 2 diabetes mellitus (JARDIANCE® rPMS in Korean patients with T2DM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24002
• EU PAS number:
  EUPAS13627
• Study ID:
  24002
• Official title and acronym:
  A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE® (empagliflozin 10mg, 25mg) in Korean patients with type 2 diabetes mellitus (JARDIANCE® rPMS in Korean patients with T2DM)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting
• Study status:
  Ongoing

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 10/06/2016

Actual: 05/07/2016

Study start date

Planned: 30/07/2016

Actual: 11/08/2016

Data analysis start date

Planned: 11/06/2020

Date of final study report

Planned: 11/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)