Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients with type 2 Diabetes Mellitus (Japanese JARDIANCE PMS, long term)

Study identification

• EU PAS number:
  EUPAS9786
• Study ID:
  43727
• Official title and acronym:
  Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients with type 2 Diabetes Mellitus (Japanese JARDIANCE PMS, long term)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 999 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:25/07/2014

Actual:25/07/2014

Study start date

Planned:01/06/2015

Actual:12/06/2015

Data analysis start date

Planned:01/06/2015

Actual:12/06/2015

Date of final study report

Planned:31/10/2021

Actual:07/10/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan K.K.

Regulatory

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