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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Adverse events
body weight
Antibodies
Blood glucose
Hypoglycaemia

Full Information

First Posted
April 5, 2006
Last Updated
January 26, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00312156
Brief Title
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes
Official Title
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 26 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Title
body weight
Title
Antibodies
Title
Blood glucose
Title
Hypoglycaemia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Bree
ZIP/Postal Code
3960
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Rijeka
ZIP/Postal Code
51 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Viborg
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Novo Nordisk Investigational Site
City
TOULOUSE cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dublin 24
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Petah Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Novo Nordisk Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Spijkenisse
ZIP/Postal Code
3201 GZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Bodø
ZIP/Postal Code
8092
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Gjøvik
ZIP/Postal Code
NO-2819
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Sarpsborg
ZIP/Postal Code
1702
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Tønsberg
ZIP/Postal Code
3116
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Leganés
ZIP/Postal Code
28911
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Helsingborg
ZIP/Postal Code
251 87
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Aberdeen
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Stirling
ZIP/Postal Code
FK8 2AU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17227321
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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