Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes
NCT ID: NCT00312156
Last Updated: 2017-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
347 participants
INTERVENTIONAL
2002-08-31
2003-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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insulin detemir
insulin NPH
insulin aspart
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
17 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Bree, , Belgium
Novo Nordisk Investigational Site
Edegem, , Belgium
Novo Nordisk Investigational Site
Rijeka, , Croatia
Novo Nordisk Investigational Site
Glostrup Municipality, , Denmark
Novo Nordisk Investigational Site
Kolding, , Denmark
Novo Nordisk Investigational Site
Odense, , Denmark
Novo Nordisk Investigational Site
Viborg, , Denmark
Novo Nordisk Investigational Site
Helsinki, , Finland
Novo Nordisk Investigational Site
Oulu, , Finland
Novo Nordisk Investigational Site
Caen, , France
Novo Nordisk Investigational Site
Paris, , France
Novo Nordisk Investigational Site
Rennes, , France
Novo Nordisk Investigational Site
Toulouse, , France
Novo Nordisk Investigational Site
Frankfurt, , Germany
Novo Nordisk Investigational Site
Hanover, , Germany
Novo Nordisk Investigational Site
Kiel, , Germany
Novo Nordisk Investigational Site
Stuttgart, , Germany
Novo Nordisk Investigational Site
Dublin, , Ireland
Novo Nordisk Investigational Site
Petah Tikva, , Israel
Novo Nordisk Investigational Site
Eindhoven, , Netherlands
Novo Nordisk Investigational Site
Spijkenisse, , Netherlands
Novo Nordisk Investigational Site
Utrecht, , Netherlands
Novo Nordisk Investigational Site
Skopje, , North Macedonia
Novo Nordisk Investigational Site
Bodø, , Norway
Novo Nordisk Investigational Site
Gjøvik, , Norway
Novo Nordisk Investigational Site
Sarpsborg, , Norway
Novo Nordisk Investigational Site
Tønsberg, , Norway
Novo Nordisk Investigational Site
Ljubljana, , Slovenia
Novo Nordisk Investigational Site
Leganés, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Helsingborg, , Sweden
Novo Nordisk Investigational Site
Linköping, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Malmo, , Sweden
Novo Nordisk Investigational Site
Örebro, , Sweden
Novo Nordisk Investigational Site
Stockholm, , Sweden
Novo Nordisk Investigational Site
Zurich, , Switzerland
Novo Nordisk Investigational Site
Aberdeen, , United Kingdom
Novo Nordisk Investigational Site
Belfast, , United Kingdom
Novo Nordisk Investigational Site
Birmingham, , United Kingdom
Novo Nordisk Investigational Site
Glasgow, , United Kingdom
Novo Nordisk Investigational Site
Stirling, , United Kingdom
Countries
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References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN304-1379
Identifier Type: -
Identifier Source: org_study_id
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