Efficacy and Safety of Insulin Detemir Versus NPH Insulin in Pregnant Women With Type 1 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00474045

Purpose

This trial is conducted in Africa, Europe, North and South America and Oceania. This trial aims for comparison of the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue and human insulin given as long-acting insulin in combination with a short-acting insulin.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: insulin detemir Drug: insulin NPH Drug: insulin aspart	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin Detemir Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Insulin Detemir Versus NPH Insulin Used in Combination With Insulin Aspart in Pregnant Women With Type 1 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: at gestational week (GW) 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety profiles including AE data and laboratory parameters [ Time Frame: during pregnancy period (from gestational weeks (GW) 8-12 to delivery) ] [ Designated as safety issue: Yes ]
Abnormal pregnancy outcome [ Time Frame: after gestational week (GW) 22 ] [ Designated as safety issue: No ]
Glycemic control parameters [ Time Frame: during pregnancy period (at gestational weeks (GW) 8-12, 14, 24 and 36) ] [ Designated as safety issue: No ]
Hypoglycaemic episodes [ Time Frame: from gestational weeks (GW) 8-12 to Follow-Up visit ] [ Designated as safety issue: Yes ]
Deterioration of diabetes complications [ Time Frame: during pregnancy period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	May 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: insulin detemir Treat-to-target, dose titration, s.c. injection Drug: insulin aspart Treat-to-target, dose titration, s.c. injection
B: Active Comparator	Drug: insulin NPH Treat-to-target, dose titration, s.c. injection Drug: insulin aspart Treat-to-target, dose titration, s.c. injection

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
Planning to become pregnant and have a screening HbA1c lesser than or equal to 9.0%or
Pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when joining the trial and a HbA1c lesser than or equal to 8.0% when pregnancy is confirmed.

Exclusion Criteria:

Known or suspected hypersensitivity to the trial product(s) or related products
Untreated hyper-or hypothyroidism
Known or suspected abuse of alcohol or narcotics
Cardiac problems
Impaired renal function
History of severe hyperemesis gravidarum
Treatment with in-vitro fertilisation or other medical infertility treatment
Impaired hepatic function
Uncontrolled hypertension
Proliferative retinopathy or maculopathy requiring acute treatment
Known to be HIV positive, Hepatitis B or Hepatitis C positive
Any concomitant medication contraindicated in pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474045

Show 17 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Jens Larsen, MD

Novo Nordisk

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1687, EudraCT No: 2006-004861-33
Study First Received:	May 15, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00474045
Health Authority:	Croatia: Ministry of Health and Social Care; Spain: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Canada: Health Canada; Denmark: Danish Medicines Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Norway: Statens Legemiddelverket; Finland: National Agency for Medicines; South Africa: Medicines Control Council; Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH; France: Agence du Médicament; Ireland: Irish Medicines Board; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009