NN5401-4149 A multi-centre, open-label, single-arm, non-interventional, post marketing sur-veillance (PMS) study of insulin degludec /insulin aspart in patients with diabetes mellitus in routine clinical practice in India

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24261
• EU PAS number:
  EUPAS6587
• Study ID:
  24261
• Official title and acronym:
  NN5401-4149 A multi-centre, open-label, single-arm, non-interventional, post marketing sur-veillance (PMS) study of insulin degludec /insulin aspart in patients with diabetes mellitus in routine clinical practice in India
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  This trial is conducted in Asia.The aim of this trial is to evaluate long term safety and efficacy 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: 17/06/2014

Study start date

Planned: 01/12/2015

Actual: 24/11/2015

Date of final study report

Planned: 01/06/2018

Actual: 31/05/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

4149-protocol-version-1.0-Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable