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Comparison of NPH Insulin and Insulin Detemir 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
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Insulin detemir naive
  • Type 1 diabetes for at least 12 months
  • HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

  • Significant concomitant diseases

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
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

insulin detemir

NPH insulin

Arm Description

insulin detemir + insulin aspart

NPH insulin + insulin aspart

Outcomes

Primary Outcome Measures

Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.

Secondary Outcome Measures

Number of Subjects Reporting Adverse Events
Number of subjects reporting adverse events during the trial (from week -2 to week 52). For details, please refer to the adverse events section.
Observed Insulin Antibody Values
Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.

Full Information

First Posted
February 13, 2007
Last Updated
January 30, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00435019
Brief Title
Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Official Title
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (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
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

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
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin detemir
Arm Type
Experimental
Arm Description
insulin detemir + insulin aspart
Arm Title
NPH insulin
Arm Type
Experimental
Arm Description
NPH insulin + insulin aspart
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
s.c. injection, once or twice daily.
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Description
s.c. injection, once or twice daily.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
s.c. injection, at main meals.
Primary Outcome Measure Information:
Title
Glycosylated Haemoglobin A1c (HbA1c)
Description
Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.
Time Frame
after 52 weeks of treatment
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Adverse Events
Description
Number of subjects reporting adverse events during the trial (from week -2 to week 52). For details, please refer to the adverse events section.
Time Frame
from week -2 to week 52
Title
Observed Insulin Antibody Values
Description
Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.
Time Frame
at 0 and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Insulin detemir naive Type 1 diabetes for at least 12 months HbA1c lesser than or equal to 11.0% Exclusion Criteria: Significant concomitant diseases
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
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Pardubice
ZIP/Postal Code
53203
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Prague 5
ZIP/Postal Code
15018
Country
Czech Republic
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
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Espoo
ZIP/Postal Code
02740
Country
Finland
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
Seinäjoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
ANGERS cedex 09
ZIP/Postal Code
49033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MONTPELLIER cedex 05
ZIP/Postal Code
34295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
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
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
00-576
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
01-184
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
125373
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
191144
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Altunizade-Istanbul
ZIP/Postal Code
34662
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Kayseri
ZIP/Postal Code
38010
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Aberdeen
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21418455
Citation
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.
Results Reference
result
PubMed Identifier
23094597
Citation
Thalange 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.
Results Reference
result
PubMed Identifier
27600385
Citation
Thalange 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.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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