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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00312156
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin NPH Drug: insulin aspart Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes
Study Start Date : August 2002
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 26 weeks ]

Secondary Outcome Measures :
  1. Adverse events
  2. body weight
  3. Antibodies
  4. Blood glucose
  5. Hypoglycaemia


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312156


Locations
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Belgium
Novo Nordisk Investigational Site
Bree, Belgium, 3960
Novo Nordisk Investigational Site
Edegem, Belgium, 2650
Croatia
Novo Nordisk Investigational Site
Rijeka, Croatia, 51 000
Denmark
Novo Nordisk Investigational Site
Glostrup, Denmark, 2600
Novo Nordisk Investigational Site
Kolding, Denmark, 6000
Novo Nordisk Investigational Site
Odense, Denmark, 5000
Novo Nordisk Investigational Site
Viborg, Denmark
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00029
Novo Nordisk Investigational Site
Oulu, Finland, 90029
France
Novo Nordisk Investigational Site
Caen, France, 14000
Novo Nordisk Investigational Site
Paris, France, 75015
Novo Nordisk Investigational Site
Rennes, France, 35056
Novo Nordisk Investigational Site
TOULOUSE cedex, France, 31059
Germany
Novo Nordisk Investigational Site
Frankfurt, Germany, 60590
Novo Nordisk Investigational Site
Hannover, Germany, 30173
Novo Nordisk Investigational Site
Kiel, Germany, 24105
Novo Nordisk Investigational Site
Stuttgart, Germany, 70176
Ireland
Novo Nordisk Investigational Site
Dublin 24, Ireland
Israel
Novo Nordisk Investigational Site
Petah Tikva, Israel, 49202
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Netherlands
Novo Nordisk Investigational Site
Eindhoven, Netherlands, 5623 EJ
Novo Nordisk Investigational Site
Spijkenisse, Netherlands, 3201 GZ
Novo Nordisk Investigational Site
Utrecht, Netherlands, 3582 KE
Norway
Novo Nordisk Investigational Site
Bodø, Norway, 8092
Novo Nordisk Investigational Site
Gjøvik, Norway, NO-2819
Novo Nordisk Investigational Site
Sarpsborg, Norway, 1702
Novo Nordisk Investigational Site
Tønsberg, Norway, 3116
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1525
Spain
Novo Nordisk Investigational Site
Leganés, Spain, 28911
Novo Nordisk Investigational Site
Madrid, Spain, 28034
Sweden
Novo Nordisk Investigational Site
Helsingborg, Sweden, 251 87
Novo Nordisk Investigational Site
Linköping, Sweden, 581 85
Novo Nordisk Investigational Site
Lund, Sweden, 221 85
Novo Nordisk Investigational Site
Malmö, Sweden, 205 02
Novo Nordisk Investigational Site
Stockholm, Sweden, 171 76
Novo Nordisk Investigational Site
Örebro, Sweden, 701 85
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8032
United Kingdom
Novo Nordisk Investigational Site
Aberdeen, United Kingdom, AB25 2ZG
Novo Nordisk Investigational Site
Belfast, United Kingdom, BT12 6BE
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B9 5SS
Novo Nordisk Investigational Site
Glasgow, United Kingdom, G51 4TF
Novo Nordisk Investigational Site
Stirling, United Kingdom, FK8 2AU
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00312156    
Other Study ID Numbers: NN304-1379
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs