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Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00365170
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : December 21, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This trial was conducted in Europe, Middle East, North America and South America.

The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: human insulin Drug: insulin aspart Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes
Study Start Date : September 2002
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Relative risk of major maternal hypoglycaemia [ Time Frame: after 24 hours ]

Secondary Outcome Measures :
  1. Relative risk of major and minor hypoglycaemia
  2. Diabetic complications
  3. Obstetric complications
  4. Other Adverse Events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 diabetes
  • Treated with insulin for at least 12 months
  • Either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening HbA1c lesser than or equal to 12.0%, or
  • Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan.

Exclusion Criteria:

  • Previous birth of child with a major congenital malformation
  • More than 2 previous multiple miscarriages or stillbirths
  • Severe hyperemesis gravidarum, requiring hospitalisation, according to Investigator judgement
  • Subjects being treated for infertility
  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Drug or alcohol abuse
  • Impaired renal, hepatic or cardiac function

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 identifier (NCT number): NCT00365170

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Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (1452, GCR) Novo Nordisk A/S

Additional Information:
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S Identifier: NCT00365170    
Other Study ID Numbers: ANA-1474
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs