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NCT Number: NCT01892319

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

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.

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Key information

Conditions

Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Zagreb, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Patients will be treated according to routine clinical practice at the discretion of the treating physician

other injectable antidiabetic treatment regimens

Drug

Patients will be treated according to routine clinical practice at the discretion of the treating physician

Primary outcomes

  1. Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death

    Time frame: Assessed up to 4 weeks after delivery

Secondary outcomes

  1. Incidence of major hypoglycaemia

    Time frame: During pregnancy

  2. Proportion of pregnancies complicated by pre-eclampsia

    Time frame: During pregnancy

  3. Proportion of pregnancies resulting in perinatal death

    Time frame: Assessed 1 week after delivery

  4. Proportion of pregnancies resulting in neonatal death

    Time frame: Assessed 4 weeks after delivery

  5. Proportion of pregnancies resulting in spontaneous abortion

    Time frame: Assessed at pregnancy termination

  6. Proportion of pregnancies resulting in pre-term delivery

    Time frame: Assessed at delivery

  7. Height

    Time frame: At the age of 1 year

  8. Weight

    Time frame: At the age of 1 year

  9. Proportion with changes (progression/regression) of major congenital malformations

    Time frame: At the age of 1 year

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 4, 2013
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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