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

Study identification

• EU PAS number:
  EUPAS26442
• Study ID:
  46569
• Official title and acronym:
  Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients with type 2 Diabetes Mellitus (Japanese TRADIANCE PMS, long term)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Study objective is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with type 2 Diabetes Mellitus under real-world use.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:30/09/2018

Actual:07/11/2018

Study start date

Planned:15/01/2019

Actual:15/01/2019

Data analysis start date

Planned:01/06/2021

Actual:01/06/2021

Date of final study report

Planned:31/03/2022

Actual:11/12/2021

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?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only