Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00435019
First received: February 13, 2007
Last updated: August 12, 2014
Last verified: July 2014
  Purpose

This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin detemir
Drug: insulin NPH
Drug: insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
    Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.


Secondary Outcome Measures:
  • Number of Subjects Reporting Adverse Events [ Time Frame: from week -2 to week 52 ] [ Designated as safety issue: Yes ]

    Number of subjects reporting adverse events during the trial (from week -2 to week 52).

    For details, please refer to the adverse events section.


  • Observed Insulin Antibody Values [ Time Frame: at 0 and 52 weeks ] [ Designated as safety issue: Yes ]
    Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.


Enrollment: 348
Study Start Date: February 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin detemir
insulin detemir + insulin aspart
Drug: insulin detemir
s.c. injection, once or twice daily.
Drug: insulin aspart
s.c. injection, at main meals.
Experimental: NPH insulin
NPH insulin + insulin aspart
Drug: insulin NPH
s.c. injection, once or twice daily.
Drug: insulin aspart
s.c. injection, at main meals.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Insulin detemir naive
  • Type 1 diabetes for at least 12 months
  • HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

  • Significant concomitant diseases
  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: NCT00435019

Locations
Bulgaria
Varna, Bulgaria, 9010
Czech Republic
Praha 5, Czech Republic, 15006
Denmark
Glostrup, Denmark, 2600
Finland
Oulu, Finland, 90029
France
Paris, France
Hungary
Budapest, Hungary
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Poland
Warszawa, Poland
Russian Federation
Moscow, Russian Federation, 119049
Turkey
Istanbul, Turkey, 111
United Kingdom
Birmingham, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Jens Larsen, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00435019     History of Changes
Other Study ID Numbers: NN304-1689, 2006-000051-18
Study First Received: February 13, 2007
Results First Received: November 3, 2009
Last Updated: August 12, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Federal Service for control in Health and Social development
Turkey: Ministry of Health Drug and Pharmaceutical Department
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Finland: Finnish Medicines Agency
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials
Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health
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
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014