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CompletedNCT00312156Updated Jan 27, 2017

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

A Phase 3 interventional study of insulin detemir and insulin NPH in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 42 sites in 16 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-01-27.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
347
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 347 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
347 participants (actual)

Interventions

  • Druginsulin detemir
  • Druginsulin NPH
  • Druginsulin aspart
06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: after 26 weeks

Secondary outcomes

  1. Adverse events

  2. body weight

  3. Antibodies

  4. Blood glucose

  5. Hypoglycaemia

07

Study locations

42 sites
  • Novo Nordisk Investigational Site
    Bree, 3960, Belgium
  • Novo Nordisk Investigational Site
    Edegem, 2650, Belgium
  • Novo Nordisk Investigational Site
    Rijeka, 51 000, Croatia
  • Novo Nordisk Investigational Site
    Glostrup, 2600, Denmark
  • Novo Nordisk Investigational Site
    Kolding, 6000, Denmark
  • Novo Nordisk Investigational Site
    Odense, 5000, Denmark
  • Novo Nordisk Investigational Site
    Viborg, Denmark
  • Novo Nordisk Investigational Site
    Helsinki, 00029, Finland
  • Novo Nordisk Investigational Site
    Oulu, 90029, Finland
  • Novo Nordisk Investigational Site
    Caen, 14000, France
  • Novo Nordisk Investigational Site
    Paris, 75015, France
  • Novo Nordisk Investigational Site
    Rennes, 35056, France
  • Novo Nordisk Investigational Site
    TOULOUSE cedex, 31059, France
  • Novo Nordisk Investigational Site
    Frankfurt, 60590, Germany
  • Novo Nordisk Investigational Site
    Hannover, 30173, Germany
  • Novo Nordisk Investigational Site
    Kiel, 24105, Germany
  • Novo Nordisk Investigational Site
    Stuttgart, 70176, Germany
  • Novo Nordisk Investigational Site
    Dublin 24, Ireland
  • Novo Nordisk Investigational Site
    Petah Tikva, 49202, Israel
  • Novo Nordisk Investigational Site
    Skopje, 1000, Macedonia, The Former Yugoslav Republic of
  • Novo Nordisk Investigational Site
    Eindhoven, 5623 EJ, Netherlands
  • Novo Nordisk Investigational Site
    Spijkenisse, 3201 GZ, Netherlands
  • Novo Nordisk Investigational Site
    Utrecht, 3582 KE, Netherlands
  • Novo Nordisk Investigational Site
    Bodø, 8092, Norway
  • Novo Nordisk Investigational Site
    Gjøvik, NO-2819, Norway
  • Novo Nordisk Investigational Site
    Sarpsborg, 1702, Norway
  • Novo Nordisk Investigational Site
    Tønsberg, 3116, Norway
  • Novo Nordisk Investigational Site
    Ljubljana, 1525, Slovenia
  • Novo Nordisk Investigational Site
    Leganés, 28911, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28034, Spain
  • Novo Nordisk Investigational Site
    Helsingborg, 251 87, Sweden
  • Novo Nordisk Investigational Site
    Linköping, 581 85, Sweden
  • Novo Nordisk Investigational Site
    Lund, 221 85, Sweden
  • Novo Nordisk Investigational Site
    Malmö, 205 02, Sweden
  • Novo Nordisk Investigational Site
    Stockholm, 171 76, Sweden
  • Novo Nordisk Investigational Site
    Örebro, 701 85, Sweden
  • Novo Nordisk Investigational Site
    Zürich, 8032, Switzerland
  • Novo Nordisk Investigational Site
    Aberdeen, AB25 2ZG, United Kingdom
  • Novo Nordisk Investigational Site
    Belfast, BT12 6BE, United Kingdom
  • Novo Nordisk Investigational Site
    Birmingham, B9 5SS, United Kingdom
  • Novo Nordisk Investigational Site
    Glasgow, G51 4TF, United Kingdom
  • Novo Nordisk Investigational Site
    Stirling, FK8 2AU, United Kingdom
08

References and documents

Publications

  • Robertson KJ, Schoenle E, Gucev Z, Mordhorst L, Gall MA, Ludvigsson J. Insulin detemir compared with NPH insulin in children and adolescents with Type 1 diabetes. Diabet Med. 2007 Jan;24(1):27-34. doi: 10.1111/j.1464-5491.2007.02024.x. PubMed 17227321 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00312156
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 7, 2006
Start date
Aug 2002
Primary completion
Aug 2003
Completion
Aug 2003
Last update
Jan 27, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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