An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus; Diabetes Mellitus, Type 2

Treatments: Drug: other injectable antidiabetic treatment regimens; Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT01892319

NN304-4016

U1111-1132-9442 (Other Identifier)

ENCEPP/SDPP/4137 (Registry Identifier)

Details and patient eligibility

About

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

Enrollment: 2,446 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Informed consent obtained before any data collection - Woman with a positive pregnancy test - Diabetes mellitus type 1 or 2, diagnosed prior to conception - Currently treated with Levemir® or other injectable antidiabetic treatment(s) - Unchanged basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception Exclusion Criteria: - Women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study

Trial design

2,446 participants in 1 patient group

All patients

Treatment:

Drug: insulin detemir

Drug: other injectable antidiabetic treatment regimens