Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients with type 2 Diabetes Mellitus (Japanese PMS, elderly patients)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20374
• EU PAS number:
  EUPAS8663
• Study ID:
  20374
• Official title and acronym:
  Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients with type 2 Diabetes Mellitus (Japanese PMS, elderly patients)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 500 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: 23/02/2015

Actual: 24/02/2015

Data analysis start date

Planned: 23/02/2015

Actual: 24/02/2015

Date of final study report

Planned: 26/08/2017

Actual: 25/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

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

Study protocol

Initial protocol

1245_98_protocol_synopsis

Regulatory

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