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

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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

Trial contacts and locations

93

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Data sourced from clinicaltrials.gov

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