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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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01892319
First received: June 27, 2013
Last updated: August 4, 2016
Last verified: August 2016
  Purpose
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 Intervention
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: other injectable antidiabetic treatment regimens

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of major hypoglycaemia [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • Proportion of pregnancies complicated by pre-eclampsia [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • Proportion of pregnancies resulting in perinatal death [ Time Frame: Assessed 1 week after delivery ] [ Designated as safety issue: No ]
  • Proportion of pregnancies resulting in neonatal death [ Time Frame: Assessed 4 weeks after delivery ] [ Designated as safety issue: No ]
  • Proportion of pregnancies resulting in spontaneous abortion [ Time Frame: Assessed at pregnancy termination ] [ Designated as safety issue: No ]
  • Proportion of pregnancies resulting in pre-term delivery [ Time Frame: Assessed at delivery ] [ Designated as safety issue: No ]
  • Height [ Time Frame: At the age of 1 year ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: At the age of 1 year ] [ Designated as safety issue: No ]
  • Proportion with changes (progression/regression) of major congenital malformations [ Time Frame: At the age of 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 2055
Study Start Date: September 2013
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892319

Locations
Croatia
Zagreb, Croatia, 10000
Denmark
Aarhus N, Denmark, 8200
Finland
Turku, Finland, FI-20520
France
TOULOUSE cedex, France, 31054
Ireland
Co. Donegal, Ireland
Israel
Petach Tikva, Israel, 49100
Italy
Padova, Italy, 35143
Netherlands
Utrecht, Netherlands, 3584 CX
Norway
Hamar, Norway, 2318
Poland
Lodz, Poland, 93-338
Romania
Galati, Romania, 800098
Spain
Sevilla, Spain, 41014
United Kingdom
Inverness, United Kingdom, IV2 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01892319     History of Changes
Other Study ID Numbers: NN304-4016  U1111-1132-9442  ENCEPP/SDPP/4137 
Study First Received: June 27, 2013
Last Updated: August 4, 2016
Health Authority: Denmark: Danish Medicines Agency
Croatia: Ministry of Health and Social Care
Finland: Finnish Medicines Agency
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: Ministry of Health
Malaysia: Ministry of Health
Netherlands: Dutch Health Care Inspectorate
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Romania: State Institute for Drug Control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016