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Completed

NCT Number: NCT00623194

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

insulin detemir

Drug

Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.

insulin aspart

Drug

Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: At 104 weeks

    Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.

  3. Fasting Plasma Glucose Values

    Time frame: At 104 weeks

    FPG (Fasting Plasma Glucose) values after 104 weeks.

  4. 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.

  5. BMI (Body Mass Index)

    Time frame: At 104 weeks

    BMI (Body Mass Index) after 104 weeks.

  6. 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.

  7. Diabetic Ketoacidosis

    Time frame: At 104 weeks

    Diabetic ketoacidosis requiring hospitalisation

  8. Insulin Dose

    Time frame: At 104 weeks

    Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.

  9. Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)

    Time frame: At 104 weeks

    Albumin Serum and Total Protein Serum after 104 weeks.

  10. Laboratory Values: Creatine Serum Umol/L

    Time frame: At 104 weeks

    Creatine serum after 104 weeks.

  11. Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)

    Time frame: At 104 weeks

    Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.

  12. 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.

  13. Laboratory Values: Leukocytes and Thrombocytes

    Time frame: At 104 weeks

    Leukocytes and Thrombocytes after 104 weeks.

  14. 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

  15. Vital Signs: Blood Pressure

    Time frame: At 104 weeks

    Blood pressure (Systolic and Diastolic) after 104 weeks.

  16. Vital Signs: Pulse

    Time frame: At 104 weeks

    Pulse at week 104

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 25, 2008
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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