NN1250-4129 A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of Tresiba® (insulin degludec) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23459
• EU PAS number:
  EUPAS6318
• Study ID:
  23459
• Official title and acronym:
  NN1250-4129 A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of Tresiba® (insulin degludec) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  This study is conducted in Asia.The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.
• Study status:
  Finalised

Research institution and networks

Institutions

Novo Nordisk

Study timelines

Date when funding contract was signed

Actual: 17/12/2013

Study start date

Planned: 24/07/2015

Actual: 24/07/2015

Date of final study report

Planned: 05/04/2018

Actual: 04/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

4129-protocol-version-1.0-Redacted

Regulatory

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