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

Novo Nordisk A/S146 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

146

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin detemirDRUG

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

insulin aspartDRUG

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

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).

Locations (32)

Outcomes

Primary Outcomes

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.

Time frame: week 0, 52 and 104

Secondary Outcomes

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.

Time frame: At 0, 52 and 104 weeks

Glycosylated Haemoglobin A1c (HbA1c)

Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.

Time frame: At 104 weeks

Fasting Plasma Glucose Values

FPG (Fasting Plasma Glucose) values after 104 weeks.

Time frame: At 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.

Time frame: Weeks 0-104

BMI (Body Mass Index)

BMI (Body Mass Index) after 104 weeks.

Time frame: At 104 weeks

SD-score (Z-score) for Body Weight

Data from ClinicalTrials.gov

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