NN304-4016 An international non-interventional prospective cohort study to evaluate the safety of treatment with Levemir® (insulin detemir) in pregnant women with diabetes mellitus

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37403
• EU PAS number:
  EUPAS4137
• Study ID:
  37403
• Official title and acronym:
  NN304-4016 An international non-interventional prospective cohort study to evaluate the safety of treatment with Levemir® (insulin detemir) in pregnant women with diabetes mellitus
• DARWIN EU® study:
  No
• Study countries:
  Croatia

  Denmark

  Finland

  France

  Germany

  Greece

  Ireland

  Israel

  Italy

  Malaysia

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Spain

  United Kingdom
• Study description:
  The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.
• Study status:
  Finalised

Research institution and networks

Institutions

Novo Nordisk

Multiple centres: 92 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 20/05/2013

Study start date

Actual: 30/09/2013

Date of final study report

Planned: 30/09/2020

Actual: 28/09/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

4016-protocol vers 2.0-redacted

Updated protocol

4016-protocol-version-6-redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)