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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00623194
First received: February 14, 2008
Last updated: June 26, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.

  • Fasting Plasma Glucose Values [ Time Frame: At 104 weeks ] [ Designated as safety issue: No ]
    FPG (Fasting Plasma Glucose) values after 104 weeks.

  • Hypoglycaemic Episodes [ Time Frame: Weeks 0-104 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    BMI (Body Mass Index) after 104 weeks.

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

  • Insulin Dose [ Time Frame: At 104 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Albumin Serum and Total Protein Serum after 104 weeks.

  • Laboratory Values: Creatine Serum Umol/L [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
    Creatine serum after 104 weeks.

  • Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L) [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.

  • Laboratory Values: Leukocytes and Thrombocytes [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
    Leukocytes and Thrombocytes after 104 weeks.

  • Fundoscopy/Fundus Photography [ Time Frame: at 52 weeks and at 104 weeks ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Blood pressure (Systolic and Diastolic) after 104 weeks.

  • Vital Signs: Pulse [ Time Frame: At 104 weeks ] [ Designated as safety issue: Yes ]
    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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623194

Locations
Bulgaria
Pleven, Bulgaria, 5800
Czech Republic
Prague 5, Czech Republic, 15018
Denmark
Glostrup, Denmark, 2600
Finland
Seinäjoki, Finland, 60220
Hungary
Miskolc, Hungary, 3501
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Poland
Kielce, Poland, 25-734
Russian Federation
Moscow, Russian Federation, 119049
Turkey
Istanbul, Turkey, 34093
United Kingdom
Norfolk, United Kingdom, NR4 7UY
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Jens Larsen, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00623194     History of Changes
Other Study ID Numbers: NN304-1690, 2006-002478-23
Study First Received: February 14, 2008
Results First Received: September 5, 2010
Last Updated: June 26, 2012
Health Authority: Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Russia: Federal Service for control in Health and Social development
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health
Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials
Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014