Overview

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

Status:
Completed
Trial end date:
2019-09-30
Target enrollment:
0
Participant gender:
Female
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Hypoglycemic Agents
Insulin
Insulin Detemir
Insulin, Globin Zinc
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 LevemirĀ® 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