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

Phase 3

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 1

Interventions: Drug: insulin detemir
Drug: insulin aspart

Registration Number: NCT00623194

Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 146

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Insulin Detemir-insulin Aspart Cross-reacting Antibodies	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

Name	Time	Method
Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)	At 104 weeks	Albumin Serum and Total Protein Serum after 104 weeks.
Laboratory Values: Creatine Serum Umol/L	At 104 weeks	Creatine serum after 104 weeks.
Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)	At 104 weeks	Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.
Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies	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)	At 104 weeks	Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.
Fasting Plasma Glucose Values	At 104 weeks	FPG (Fasting Plasma Glucose) values after 104 weeks.
Hypoglycaemic Episodes	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)	At 104 weeks	BMI (Body Mass Index) after 104 weeks.
SD-score (Z-score) for Body Weight	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	At 104 weeks	Diabetic ketoacidosis requiring hospitalisation
Insulin Dose	At 104 weeks	Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.
Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)	At 104 weeks	Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.
Laboratory Values: Leukocytes and Thrombocytes	At 104 weeks	Leukocytes and Thrombocytes after 104 weeks.
Fundoscopy/Fundus Photography	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	At 104 weeks	Blood pressure (Systolic and Diastolic) after 104 weeks.
Vital Signs: Pulse	At 104 weeks	Pulse at week 104