A 52-Week, Multinational, Multi-Centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Children and Adolescents 2-16 years with Type 1 Diabetes on a Basal-Bolus Regimen with Insulin Aspart as Bolus Insuli

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 344

Inclusion Criteria

1.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.
2.Boy or girl diagnosed with type 1 diabetes.
3.Age: 2-16 years at randomisation
4.Diagnosed with type 1 diabetes =12 months prior to inclusion
5.Insulin detemir naïve (all other insulins and insulin regimens are allowed)
6.Total daily dose of insulin = 2 U/kg
7.Maximum Body Mass Index (BMI) according to Table 6–2 (see protocol)
8.HbA1c = 11%
9.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.
10.Subject is likely to comply with the Investigators instruction
11.Ability and willingness to perform plasma glucose profiles using a Blood Glucose Meter at home as evidenced by a complete 9-point Self Measured Plasma Glucose Profile obtained over a single 24-hour period during the screening period.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known or suspected allergy to trial product(s) or related products.
2.Previous participation in this trial. Participation is defined as randomisation.
3.Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator.
4.Mental incapacity, unwillingness or language barriers, precluding adequate understanding or co-operation (child and parent should be evaluated as a unit).
5.Pregnant, breast-feeding or the intention of becoming pregnant.
6.The receipt of any investigational drug within 1 month prior to this trial.
7.Known hypoglycaemic unawareness as judged by the Investigator or recurrent major hypoglycaemic events.
8.Any disease or condition that the Investigator feels will interfere with the trial e.g. highly variable eating habits, employment as a shift worker etc.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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