A regulatory requirement non-interventional study to monitor the safety and effectiveness of Glyxambi (empagliflozin/linagliptin, 10/5mg, 25/5mg) in Korean patients with type 2 diabetes mellitus

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47610
• EU PAS number:
  EUPAS44579
• Study ID:
  47610
• Official title and acronym:
  A regulatory requirement non-interventional study to monitor the safety and effectiveness of Glyxambi (empagliflozin/linagliptin, 10/5mg, 25/5mg) in Korean patients with type 2 diabetes mellitus
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  To monitor the safety profile and effectiveness of Esgliteo in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 20/12/2021

Study start date

Planned: 31/03/2022

Actual: 26/03/2022

Date of final study report

Planned: 30/06/2023

Actual: 02/08/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Study protocol

Updated protocol

Eng Esgliteo PMS_1275-0028-protocol_v5.0_28Oct2022_clean_Redacted.pdf

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

1275-0028