Type I Diabetes MedDRA version: 8.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To compare the glycaemic control, measured as HbA1c, of insulin detemir administered once or twice daily plus mealtime insulin aspart with NPH insulin administered once or twice daily plus mealtime insulin aspart in children and adolescents with type 1 diabetes.;Secondary Objective: To compare insulin detemir/insulin aspart to NPH insulin/insulin aspart with respect to: •Formation of insulin antibodies: insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/aspart cross-reacting antibodies. •Intra-subject variation of Self Measured Plasma Glucose (SMPG) during treatment, before breakfast and before dinner values. •9-point Self Measured Plasma Glucose Profile. •Nocturnal plasma glucose values. •Fasting plasma glucose values. •Incidence of hypoglycaemic episodes (mild, moderate and severe) overall, daytime and night-time. •BMI and SD-score (z-score) for weight . •Incidence of adverse events. •Incidence of diabetic ketoacidosis requiring hospitalisation. •Insulin dose •Laboratory safety parameters (haematology and biochemistry), physical examination and fundoscopy/fundusphotography •Vital signs. •Injection pain assessment using a facial visual analogue scale (VAS). ;Primary end point(s): Efficacy Endpoints: •HbA1c, end of trial •Fasting Plasma Glucose (FPGlab), end of trial •9-points Plasma Glucose (PG) profile, end of trial •Self Measured Plasma Glucose (SMPG), end of trial •Nocturnal plasma glucose, end of trial Safety Endpoints: •Insulin antibodies: Insulin detemir specific, insulin aspart specific, and insulin detemir/aspart cross-reacting antibodies during treatment •Vital signs, end of trial •Incidence of hypoglycaemia (mild, moderate or severe) – total, daytime and nocturnal during treatment •Body weight, BMI and SD-score (z-score) for weight , end of trial •Adverse events during treatment •Safety laboratory parameters (haematology and biochemistry), physical examination and fundoscopy/fundu | — |
Countries
Bulgaria, Czech Republic, Denmark, Finland, France, Hungary
Outcome results
None listed