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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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ClinicalTrials.gov Identifier: NCT01892319
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: other injectable antidiabetic treatment regimens

Study Design
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Study Type : Observational
Actual Enrollment : 2446 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus
Actual Study Start Date : September 30, 2013
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
All patients Drug: insulin detemir
Patients will be treated according to routine clinical practice at the discretion of the treating physician

Drug: other injectable antidiabetic treatment regimens
Patients will be treated according to routine clinical practice at the discretion of the treating physician


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with diabetes mellitus, who are pregnant and treated with Levemir® or other injectable antidiabetic treatment regimens, and who have not changed basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception will be included in the Diabetes Pregnancy Registry.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892319


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01892319    
Other Study ID Numbers: NN304-4016
U1111-1132-9442 ( Other Identifier: WHO )
ENCEPP/SDPP/4137 ( Registry Identifier: EU PAS )
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs