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

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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin human Insulin aspart

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365170

Show 18 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Mette Louise Jakobsen

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

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

McCance DR, Damm P, Mathiesen ER, Hod M, Kaaja R, Dunne F, Jensen LE, Mersebach H. Evaluation of insulin antibodies and placental transfer of insulin aspart in pregnant women with type 1 diabetes mellitus. Diabetologia. 2008 Nov;51(11):2141-3. Epub 2008 Aug 23. No abstract available.

Hod M, Jovanovic L. Improving outcomes in pregnant women with type 1 diabetes. Diabetes Care. 2007 Jul;30(7):e62. No abstract available.

Altschuler JA, Casella SJ, MacKenzie TA, Curtis KM. The effect of cinnamon on A1C among adolescents with type 1 diabetes. Diabetes Care. 2007 Apr;30(4):813-6.

Williams MM, Clouse RE, Nix BD, Rubin EH, Sayuk GS, McGill JB, Gelenberg AJ, Ciechanowski PS, Hirsch IB, Lustman PJ. Efficacy of sertraline in prevention of depression recurrence in older versus younger adults with diabetes. Diabetes Care. 2007 Apr;30(4):801-6.

Mathiesen ER, Kinsley B, Amiel SA, Heller S, McCance D, Duran S, Bellaire S, Raben A; Insulin Aspart Pregnancy Study Group. Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women. Diabetes Care. 2007 Apr;30(4):771-6.

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 aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013