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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00365170
First received: August 10, 2006
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: human insulin
Drug: insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relative risk of major maternal hypoglycaemia [ Time Frame: after 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative risk of major and minor hypoglycaemia [ Designated as safety issue: No ]
  • Diabetic complications [ Designated as safety issue: No ]
  • Obstetric complications [ Designated as safety issue: No ]
  • Other Adverse Events [ Designated as safety issue: No ]

Enrollment: 419
Study Start Date: September 2002
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00365170

  Show 18 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mette Louise Jakobsen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00365170     History of Changes
Other Study ID Numbers: ANA-1474
Study First Received: August 10, 2006
Last Updated: May 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Croatia: Ministry of Health and Social Care
Russia: Pharmacological Committee, Ministry of Health
Denmark: Danish Medicines Agency
Canada: Health Canada
Poland: Ministry of Health
Finland: Finnish Medicines Agency
Bulgaria: Bulgarian Drug Agency
Netherlands: Dutch Health Care Inspectorate
Austria: Federal Ministry for Health and Women
Israel: Israeli Health Ministry Pharmaceutical Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Ireland: Irish Medicines Board
Norway: Norwegian Medicines Agency
Greece: National Organization for Medicines
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on August 20, 2014