search
Back to results

Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin detemir
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

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

Inclusion Criteria:

  • Informed Consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the subject must sign and date the Informed Consent Form.
  • Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689.
  • Fertile females (girls who have had their first menstrual period) must use adequate contraception (barrier methods, contraceptive pills or intrauterine device (IUD)) if there is any risk of pregnancy in the opinion of the Investigator. For Denmark and France only contraceptive pills or intrauterine device are considered as adequate contraceptive methods.

Exclusion Criteria:

  • Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator.
  • Pregnant or the intention of becoming pregnant.
  • Previous participation in this trial (defined as enrolment).

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

insulin detemir

Arm Description

Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)

Outcomes

Primary Outcome Measures

Insulin Detemir-insulin Aspart Cross-reacting Antibodies
Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.

Secondary Outcome Measures

Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies
Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.
Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.
Fasting Plasma Glucose Values
FPG (Fasting Plasma Glucose) values after 104 weeks.
Hypoglycaemic Episodes
Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment. Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment.
BMI (Body Mass Index)
BMI (Body Mass Index) after 104 weeks.
SD-score (Z-score) for Body Weight
Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.
Diabetic Ketoacidosis
Diabetic ketoacidosis requiring hospitalisation
Insulin Dose
Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.
Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)
Albumin Serum and Total Protein Serum after 104 weeks.
Laboratory Values: Creatine Serum Umol/L
Creatine serum after 104 weeks.
Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)
Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.
Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)
Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.
Laboratory Values: Leukocytes and Thrombocytes
Leukocytes and Thrombocytes after 104 weeks.
Fundoscopy/Fundus Photography
Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant
Vital Signs: Blood Pressure
Blood pressure (Systolic and Diastolic) after 104 weeks.
Vital Signs: Pulse
Pulse at week 104

Full Information

First Posted
February 14, 2008
Last Updated
October 17, 2016
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT00623194
Brief Title
Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
Official Title
A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (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 assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin detemir
Arm Type
Experimental
Arm Description
Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.
Primary Outcome Measure Information:
Title
Insulin Detemir-insulin Aspart Cross-reacting Antibodies
Description
Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.
Time Frame
week 0, 52 and 104
Secondary Outcome Measure Information:
Title
Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies
Description
Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.
Time Frame
At 0, 52 and 104 weeks
Title
Glycosylated Haemoglobin A1c (HbA1c)
Description
Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.
Time Frame
At 104 weeks
Title
Fasting Plasma Glucose Values
Description
FPG (Fasting Plasma Glucose) values after 104 weeks.
Time Frame
At 104 weeks
Title
Hypoglycaemic Episodes
Description
Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment. Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment.
Time Frame
Weeks 0-104
Title
BMI (Body Mass Index)
Description
BMI (Body Mass Index) after 104 weeks.
Time Frame
At 104 weeks
Title
SD-score (Z-score) for Body Weight
Description
Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.
Time Frame
At 104 weeks
Title
Diabetic Ketoacidosis
Description
Diabetic ketoacidosis requiring hospitalisation
Time Frame
At 104 weeks
Title
Insulin Dose
Description
Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.
Time Frame
At 104 weeks
Title
Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)
Description
Albumin Serum and Total Protein Serum after 104 weeks.
Time Frame
At 104 weeks
Title
Laboratory Values: Creatine Serum Umol/L
Description
Creatine serum after 104 weeks.
Time Frame
At 104 weeks
Title
Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)
Description
Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.
Time Frame
At 104 weeks
Title
Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)
Description
Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.
Time Frame
At 104 weeks
Title
Laboratory Values: Leukocytes and Thrombocytes
Description
Leukocytes and Thrombocytes after 104 weeks.
Time Frame
At 104 weeks
Title
Fundoscopy/Fundus Photography
Description
Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant
Time Frame
at 52 weeks and at 104 weeks
Title
Vital Signs: Blood Pressure
Description
Blood pressure (Systolic and Diastolic) after 104 weeks.
Time Frame
At 104 weeks
Title
Vital Signs: Pulse
Description
Pulse at week 104
Time Frame
At 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed Consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the subject must sign and date the Informed Consent Form. Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689. Fertile females (girls who have had their first menstrual period) must use adequate contraception (barrier methods, contraceptive pills or intrauterine device (IUD)) if there is any risk of pregnancy in the opinion of the Investigator. For Denmark and France only contraceptive pills or intrauterine device are considered as adequate contraceptive methods. Exclusion Criteria: Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator. Pregnant or the intention of becoming pregnant. Previous participation in this trial (defined as enrolment).
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
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
Turku
ZIP/Postal Code
20100
Country
Finland
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
Warszawa
ZIP/Postal Code
01-184
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
193144
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
Aberdeen
ZIP/Postal Code
AB25 2ZG
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
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
background
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689

We'll reach out to this number within 24 hrs