Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes
1 other identifier
interventional
347
15 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes
Started Aug 2002
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 5, 2006
CompletedFirst Posted
Study publicly available on registry
April 7, 2006
CompletedJanuary 27, 2017
January 1, 2017
1 year
April 5, 2006
January 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
after 26 weeks
Secondary Outcomes (5)
Adverse events
body weight
Antibodies
Blood glucose
Hypoglycaemia
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (42)
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 Municipality, 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, 31059, France
Novo Nordisk Investigational Site
Frankfurt, 60590, Germany
Novo Nordisk Investigational Site
Hanover, 30173, Germany
Novo Nordisk Investigational Site
Kiel, 24105, Germany
Novo Nordisk Investigational Site
Stuttgart, 70176, Germany
Novo Nordisk Investigational Site
Dublin, Ireland
Novo Nordisk Investigational Site
Petah Tikva, 49202, Israel
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
Skopje, 1000, North Macedonia
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
Malmo, 205 02, Sweden
Novo Nordisk Investigational Site
Örebro, 701 85, Sweden
Novo Nordisk Investigational Site
Stockholm, 171 76, Sweden
Novo Nordisk Investigational Site
Zurich, 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
Related Publications (1)
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.
PMID: 17227321RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2006
First Posted
April 7, 2006
Study Start
August 1, 2002
Primary Completion
August 1, 2003
Study Completion
August 1, 2003
Last Updated
January 27, 2017
Record last verified: 2017-01