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

January 26, 2017 updated by: Novo Nordisk A/S
The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bree, Belgium, 3960
        • Novo Nordisk Investigational Site
      • Edegem, Belgium, 2650
        • Novo Nordisk Investigational Site
  • Croatia
      • Rijeka, Croatia, 51 000
        • Novo Nordisk Investigational Site
  • Denmark
      • Glostrup, Denmark, 2600
        • Novo Nordisk Investigational Site
      • Kolding, Denmark, 6000
        • Novo Nordisk Investigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk Investigational Site
      • Viborg, Denmark
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90029
        • Novo Nordisk Investigational Site
  • France
      • Caen, France, 14000
        • Novo Nordisk Investigational Site
      • Paris, France, 75015
        • Novo Nordisk Investigational Site
      • Rennes, France, 35056
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31059
        • Novo Nordisk Investigational Site
  • Germany
      • Frankfurt, Germany, 60590
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30173
        • Novo Nordisk Investigational Site
      • Kiel, Germany, 24105
        • Novo Nordisk Investigational Site
      • Stuttgart, Germany, 70176
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin 24, Ireland
        • Novo Nordisk Investigational Site
  • Israel
      • Petah Tikva, Israel, 49202
        • Novo Nordisk Investigational Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • Novo Nordisk Investigational Site
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Novo Nordisk Investigational Site
      • Spijkenisse, Netherlands, 3201 GZ
        • Novo Nordisk Investigational Site
      • Utrecht, Netherlands, 3582 KE
        • Novo Nordisk Investigational Site
  • Norway
      • Bodø, Norway, 8092
        • Novo Nordisk Investigational Site
      • Gjøvik, Norway, NO-2819
        • Novo Nordisk Investigational Site
      • Sarpsborg, Norway, 1702
        • Novo Nordisk Investigational Site
      • Tønsberg, Norway, 3116
        • Novo Nordisk Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1525
        • Novo Nordisk Investigational Site
  • Spain
      • Leganés, Spain, 28911
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28034
        • Novo Nordisk Investigational Site
  • Sweden
      • Helsingborg, Sweden, 251 87
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 581 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Malmö, Sweden, 205 02
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 171 76
        • Novo Nordisk Investigational Site
      • Örebro, Sweden, 701 85
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8032
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZG
        • Novo Nordisk Investigational Site
      • Belfast, United Kingdom, BT12 6BE
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, B9 5SS
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G51 4TF
        • Novo Nordisk Investigational Site
      • Stirling, United Kingdom, FK8 2AU
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes for at least 12 months
  • Informed consent obtained
  • BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2.
  • HbA1c equal to or less than 12.0%

Exclusion Criteria:

  • Proliferate retinopathy or maculopathy
  • Total daily insulin dose greater than 2.00 IU/kg
  • Any condition or disease that rule out trial participation according to the judgement of the investigator.
  • Mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
  • A life-style incompatible with trial participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: after 26 weeks
after 26 weeks

Secondary Outcome Measures

Outcome Measure
Adverse events
Blood glucose
Hypoglycaemia
body weight
Antibodies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 7, 2006

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1379

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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