Status:
COMPLETED
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Eligibility:
FEMALE
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- Women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study
Key Trial Info
Start Date :
September 30 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
2446 Patients enrolled
Trial Details
Trial ID
NCT01892319
Start Date
September 30 2013
End Date
September 30 2019
Last Update
November 19 2019
Active Locations (93)
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1
Novo Nordisk Investigational Site
Zagreb, Croatia, 10000
2
Novo Nordisk Investigational Site
Pori, Finland, 28500
3
Novo Nordisk Investigational Site
Tampere, Finland, 33521
4
Novo Nordisk Investigational Site
Turku, Finland, 20520