Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents 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: NCT00435019
Recruitment Status : Completed
First Posted : February 14, 2007
Results First Posted : December 8, 2009
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin NPH Drug: insulin aspart Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: after 52 weeks of treatment ]
    Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.

Secondary Outcome Measures :
  1. Number of Subjects Reporting Adverse Events [ Time Frame: from week -2 to week 52 ]

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

    For details, please refer to the adverse events section.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00435019

  Show 43 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S Identifier: NCT00435019     History of Changes
Other Study ID Numbers: NN304-1689
2006-000051-18 ( EudraCT Number )
First Posted: February 14, 2007    Key Record Dates
Results First Posted: December 8, 2009
Last Update Posted: March 10, 2017
Last Verified: January 2017

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 degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs