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

January 30, 2017 updated by: Novo Nordisk A/S

An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

348

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

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1606
        • Novo Nordisk Investigational Site
      • Varna, Bulgaria, 9010
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Olomouc, Czech Republic, 77520
        • Novo Nordisk Investigational Site
      • Pardubice, Czech Republic, 53203
        • Novo Nordisk Investigational Site
      • Prague 5, Czech Republic, 15018
        • 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, 8800
        • Novo Nordisk Investigational Site
  • Finland
      • Espoo, Finland, 02740
        • Novo Nordisk Investigational Site
      • Helsinki, Finland, 00029
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90029
        • Novo Nordisk Investigational Site
      • Seinäjoki, Finland, 60220
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33520
        • Novo Nordisk Investigational Site
      • Turku, Finland, 20100
        • Novo Nordisk Investigational Site
  • France
      • ANGERS cedex 09, France, 49033
        • Novo Nordisk Investigational Site
      • MONTPELLIER cedex 05, France, 34295
        • Novo Nordisk Investigational Site
      • Paris, France, 75015
        • Novo Nordisk Investigational Site
      • Toulouse, France, 31059
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1083
        • Novo Nordisk Investigational Site
      • Miskolc, Hungary, 3501
        • Novo Nordisk Investigational Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • Novo Nordisk Investigational Site
  • Poland
      • Gdansk, Poland, 80-211
        • Novo Nordisk Investigational Site
      • Kielce, Poland, 25-734
        • Novo Nordisk Investigational Site
      • Siedlce, Poland, 08-110
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 00-576
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 04-730
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 01-184
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 125373
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 119049
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191144
        • Novo Nordisk Investigational Site
  • Turkey
      • Altunizade-Istanbul, Turkey, 34662
        • Novo Nordisk Investigational Site
      • Antalya, Turkey, 07059
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34093
        • Novo Nordisk Investigational Site
      • Izmir, Turkey, 35340
        • Novo Nordisk Investigational Site
      • Kayseri, Turkey, 38010
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZG
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, B4 6NH
        • Novo Nordisk Investigational Site
      • Cambridge, United Kingdom, CB2 2QQ
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk Investigational Site
      • Norfolk, United Kingdom, NR4 7UY
        • 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

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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)

Arms and Interventions

Participant Group / 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 aspart
s.c. injection, at main meals.
Drug: insulin NPH
s.c. injection, once or twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after 52 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from week -2 to week 52
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.
at 0 and 52 weeks

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

February 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 13, 2007

First Submitted That Met QC Criteria

February 13, 2007

First Posted (Estimate)

February 14, 2007

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1689
  • 2006-000051-18 (EudraCT Number)

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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