NN304-4528: Retrospective Cohort study of all-Cause and Cardiovascular Mortality in type 2 diabetes patients using basal insulin Detemir and Glargine

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35510
• EU PAS number:
  EUPAS29708
• Study ID:
  35510
• Official title and acronym:
  NN304-4528: Retrospective Cohort study of all-Cause and Cardiovascular Mortality in type 2 diabetes patients using basal insulin Detemir and Glargine
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study will examine the influence of the basal insulins Detemir and Glargine on risk of cardiovascular death and death from all causes in patients treated by their general practitioner in United Kingdom (UK).
• Study status:
  Finalised

Research institution and networks

Institutions

Novo Nordisk

Study timelines

Date when funding contract was signed

Actual: 18/03/2019

Study start date

Planned: 21/05/2019

Actual: 21/05/2019

Date of final study report

Planned: 20/05/2020

Actual: 18/05/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

4528-protocol-eu-pas-reg-redacted

Regulatory

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

Other study registration identification numbers and links

UTN: U1111-1233-0930