NN1250-4189 A multi-centre, prospective, non-interventional study of insulin degludec investigating the safety and effectiveness in a real world population with type 1 and 2 diabetes mellitus (ReFLeCT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29493
• EU PAS number:
  EUPAS7880
• Study ID:
  29493
• Official title and acronym:
  NN1250-4189 A multi-centre, prospective, non-interventional study of insulin degludec investigating the safety and effectiveness in a real world population with type 1 and 2 diabetes mellitus (ReFLeCT)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Italy

  Netherlands

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  This study is conducted in Europe.The aim of the study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.
• Study status:
  Finalised

Research institution and networks

Institutions

Novo Nordisk

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 05/11/2014

Study start date

Planned: 16/03/2015

Actual: 16/03/2015

Date of final study report

Planned: 19/03/2019

Actual: 27/03/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

4189-protocol-version-2-redacted

Updated protocol

4189-protocol-version-5-redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable