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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00623194
First received: February 14, 2008
Last updated: October 17, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin detemir
Drug: insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Insulin Detemir-insulin Aspart Cross-reacting Antibodies [ Time Frame: week 0, 52 and 104 ]
    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 [ Time Frame: At 0, 52 and 104 weeks ]
    Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.

  • Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: At 104 weeks ]
    Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.

  • Fasting Plasma Glucose Values [ Time Frame: At 104 weeks ]
    FPG (Fasting Plasma Glucose) values after 104 weeks.

  • Hypoglycaemic Episodes [ Time Frame: Weeks 0-104 ]

    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) [ Time Frame: At 104 weeks ]
    BMI (Body Mass Index) after 104 weeks.

  • SD-score (Z-score) for Body Weight [ Time Frame: At 104 weeks ]
    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 [ Time Frame: At 104 weeks ]
    Diabetic ketoacidosis requiring hospitalisation

  • Insulin Dose [ Time Frame: At 104 weeks ]
    Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.

  • Laboratory Values: Albumin Serum and Total Protein Serum (g/dL) [ Time Frame: At 104 weeks ]
    Albumin Serum and Total Protein Serum after 104 weeks.

  • Laboratory Values: Creatine Serum Umol/L [ Time Frame: At 104 weeks ]
    Creatine serum after 104 weeks.

  • Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L) [ Time Frame: At 104 weeks ]
    Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.

  • Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L) [ Time Frame: At 104 weeks ]
    Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.

  • Laboratory Values: Leukocytes and Thrombocytes [ Time Frame: At 104 weeks ]
    Leukocytes and Thrombocytes after 104 weeks.

  • Fundoscopy/Fundus Photography [ Time Frame: at 52 weeks and at 104 weeks ]

    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 [ Time Frame: At 104 weeks ]
    Blood pressure (Systolic and Diastolic) after 104 weeks.

  • Vital Signs: Pulse [ Time Frame: At 104 weeks ]
    Pulse at week 104


Enrollment: 146
Study Start Date: February 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin detemir
Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
Drug: insulin detemir
Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.
Drug: insulin aspart
Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00623194

  Show 32 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00623194     History of Changes
Other Study ID Numbers: NN304-1690
2006-002478-23 ( EudraCT Number )
Study First Received: February 14, 2008
Results First Received: September 5, 2010
Last Updated: October 17, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017