Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes
2 other identifiers
interventional
348
11 countries
43
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
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 Feb 2007
Typical duration for phase_3 diabetes
43 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
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 13, 2007
CompletedFirst Posted
Study publicly available on registry
February 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
December 8, 2009
CompletedMarch 10, 2017
January 1, 2017
1.6 years
February 13, 2007
November 3, 2009
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.
after 52 weeks of treatment
Secondary Outcomes (2)
Number of Subjects Reporting Adverse Events
from week -2 to week 52
Observed Insulin Antibody Values
at 0 and 52 weeks
Study Arms (2)
insulin detemir
EXPERIMENTALinsulin detemir + insulin aspart
NPH insulin
EXPERIMENTALNPH insulin + insulin aspart
Interventions
Eligibility Criteria
You may qualify if:
- Insulin detemir naive
- Type 1 diabetes for at least 12 months
- HbA1c lesser than or equal to 11.0%
You may not qualify if:
- Significant concomitant diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (43)
Novo Nordisk Investigational Site
Pleven, 5800, Bulgaria
Novo Nordisk Investigational Site
Sofia, 1606, Bulgaria
Novo Nordisk Investigational Site
Varna, 9010, Bulgaria
Novo Nordisk Investigational Site
Olomouc, 77520, Czechia
Novo Nordisk Investigational Site
Pardubice, 53203, Czechia
Novo Nordisk Investigational Site
Prague, 15018, Czechia
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, 8800, Denmark
Novo Nordisk Investigational Site
Espoo, 02740, Finland
Novo Nordisk Investigational Site
Helsinki, 00029, Finland
Novo Nordisk Investigational Site
Oulu, 90029, Finland
Novo Nordisk Investigational Site
Seinäjoki, 60220, Finland
Novo Nordisk Investigational Site
Tampere, 33520, Finland
Novo Nordisk Investigational Site
Turku, 20100, Finland
Novo Nordisk Investigational Site
Angers, 49033, France
Novo Nordisk Investigational Site
Montpellier, 34295, France
Novo Nordisk Investigational Site
Paris, 75015, France
Novo Nordisk Investigational Site
Toulouse, 31059, France
Novo Nordisk Investigational Site
Budapest, 1083, Hungary
Novo Nordisk Investigational Site
Miskolc, 3501, Hungary
Novo Nordisk Investigational Site
Skopje, 1000, North Macedonia
Novo Nordisk Investigational Site
Gdansk, 80-211, Poland
Novo Nordisk Investigational Site
Kielce, 25-734, Poland
Novo Nordisk Investigational Site
Siedlce, 08-110, Poland
Novo Nordisk Investigational Site
Warsaw, 00-576, Poland
Novo Nordisk Investigational Site
Warsaw, 01-184, Poland
Novo Nordisk Investigational Site
Warsaw, 04-730, Poland
Novo Nordisk Investigational Site
Moscow, 117036, Russia
Novo Nordisk Investigational Site
Moscow, 119049, Russia
Novo Nordisk Investigational Site
Moscow, 125373, Russia
Novo Nordisk Investigational Site
Saint Petersburg, 191144, Russia
Novo Nordisk Investigational Site
Altunizade-Istanbul, 34662, Turkey (Türkiye)
Novo Nordisk Investigational Site
Antalya, 07059, Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, 34093, Turkey (Türkiye)
Novo Nordisk Investigational Site
Izmir, 35340, Turkey (Türkiye)
Novo Nordisk Investigational Site
Kayseri, 38010, Turkey (Türkiye)
Novo Nordisk Investigational Site
Aberdeen, AB25 2ZG, United Kingdom
Novo Nordisk Investigational Site
Birmingham, B4 6NH, United Kingdom
Novo Nordisk Investigational Site
Cambridge, CB2 2QQ, United Kingdom
Novo Nordisk Investigational Site
Dundee, DD1 9SY, United Kingdom
Novo Nordisk Investigational Site
Norfolk, NR4 7UY, United Kingdom
Related Publications (3)
Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes. 2011 Nov;12(7):632-41. doi: 10.1111/j.1399-5448.2010.00750.x. Epub 2011 Mar 21.
PMID: 21418455RESULTThalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. Diabet Med. 2013 Feb;30(2):216-25. doi: 10.1111/dme.12041.
PMID: 23094597RESULTThalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. doi: 10.1007/s13300-016-0196-5. Epub 2016 Sep 6.
PMID: 27600385DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Public Access to Clinical Trials
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
February 13, 2007
First Posted
February 14, 2007
Study Start
February 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
March 10, 2017
Results First Posted
December 8, 2009
Record last verified: 2017-01