A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE DUO® (empagliflozin/metformin, 5/500mg, 5/850mg, 5/1000mg, 12.5/500mg, 12.5/850mg, 12.5/1000mg) in Korean patients with type 2 diabetes mellitus (JARDIANCE DUO® rPMS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26822
• EU PAS number:
  EUPAS24004
• Study ID:
  26822
• Official title and acronym:
  A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE DUO® (empagliflozin/metformin, 5/500mg, 5/850mg, 5/1000mg, 12.5/500mg, 12.5/850mg, 12.5/1000mg) in Korean patients with type 2 diabetes mellitus (JARDIANCE DUO® rPMS)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  To monitor the safety profile and effectiveness of JARDIANCE DUO in Korean 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: 15/09/2018

Actual: 21/08/2018

Study start date

Planned: 31/10/2018

Actual: 08/10/2018

Data analysis start date

Planned: 31/03/2020

Date of final study report

Planned: 30/11/2020

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)?:
  Not applicable

Other study registration identification numbers and links

1276-0039