E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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/fundusphotography, end of trial •Occurrence of ketoacidosis requiring hospitalisation during treatment •Insulin dose during treatment •Injection pain assessment using a facial visual analogue scale (VAS).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |