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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00312156
Collaborator
(none)
347
Enrollment
42
Locations
12
Duration (Months)
8.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: insulin detemir
  • Drug: insulin NPH
  • Drug: insulin aspart
 Phase 3

Study Design

Study Type:
Interventional
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 :
Aug 1, 2002
Actual Primary Completion Date :
Aug 1, 2003
Actual Study Completion Date :
Aug 1, 2003

Outcome Measures

Primary Outcome Measures

  1. HbA1c [after 26 weeks]

Secondary Outcome Measures

  1. Adverse events []

  2. body weight []

  3. Antibodies []

  4. Blood glucose []

  5. Hypoglycaemia []

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Bree Belgium 3960
2 Novo Nordisk Investigational Site Edegem Belgium 2650
3 Novo Nordisk Investigational Site Rijeka Croatia 51 000
4 Novo Nordisk Investigational Site Glostrup Denmark 2600
5 Novo Nordisk Investigational Site Kolding Denmark 6000
6 Novo Nordisk Investigational Site Odense Denmark 5000
7 Novo Nordisk Investigational Site Viborg Denmark
8 Novo Nordisk Investigational Site Helsinki Finland 00029
9 Novo Nordisk Investigational Site Oulu Finland 90029
10 Novo Nordisk Investigational Site Caen France 14000
11 Novo Nordisk Investigational Site Paris France 75015
12 Novo Nordisk Investigational Site Rennes France 35056
13 Novo Nordisk Investigational Site TOULOUSE cedex France 31059
14 Novo Nordisk Investigational Site Frankfurt Germany 60590
15 Novo Nordisk Investigational Site Hannover Germany 30173
16 Novo Nordisk Investigational Site Kiel Germany 24105
17 Novo Nordisk Investigational Site Stuttgart Germany 70176
18 Novo Nordisk Investigational Site Dublin 24 Ireland
19 Novo Nordisk Investigational Site Petah Tikva Israel 49202
20 Novo Nordisk Investigational Site Skopje Macedonia, The Former Yugoslav Republic of 1000
21 Novo Nordisk Investigational Site Eindhoven Netherlands 5623 EJ
22 Novo Nordisk Investigational Site Spijkenisse Netherlands 3201 GZ
23 Novo Nordisk Investigational Site Utrecht Netherlands 3582 KE
24 Novo Nordisk Investigational Site Bodø Norway 8092
25 Novo Nordisk Investigational Site Gjøvik Norway NO-2819
26 Novo Nordisk Investigational Site Sarpsborg Norway 1702
27 Novo Nordisk Investigational Site Tønsberg Norway 3116
28 Novo Nordisk Investigational Site Ljubljana Slovenia 1525
29 Novo Nordisk Investigational Site Leganés Spain 28911
30 Novo Nordisk Investigational Site Madrid Spain 28034
31 Novo Nordisk Investigational Site Helsingborg Sweden 251 87
32 Novo Nordisk Investigational Site Linköping Sweden 581 85
33 Novo Nordisk Investigational Site Lund Sweden 221 85
34 Novo Nordisk Investigational Site Malmö Sweden 205 02
35 Novo Nordisk Investigational Site Stockholm Sweden 171 76
36 Novo Nordisk Investigational Site Örebro Sweden 701 85
37 Novo Nordisk Investigational Site Zürich Switzerland 8032
38 Novo Nordisk Investigational Site Aberdeen United Kingdom AB25 2ZG
39 Novo Nordisk Investigational Site Belfast United Kingdom BT12 6BE
40 Novo Nordisk Investigational Site Birmingham United Kingdom B9 5SS
41 Novo Nordisk Investigational Site Glasgow United Kingdom G51 4TF
42 Novo Nordisk Investigational Site Stirling United Kingdom FK8 2AU

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00312156
Other Study ID Numbers:
  • NN304-1379
First Posted:
Apr 7, 2006
Last Update Posted:
Jan 27, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef

Study Results

No Results Posted as of Jan 27, 2017