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 | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10014698 |
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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 |
To compare a BIAsp70/30 and short-acting insulin or rapid-acting analogue plus glargine regimen (group 1) with the same insulin regimen not including BIAsp70/30 (group 2) in >6- <18 yr old children and adolescents with T1DM diagnosed since 2 years with no prior BIAsp70/30 therapy and without other autoimmune diseases |
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E.2.2 | Secondary objectives of the trial |
1) Metabolic assessment: variability and glycaemic exposure by means of self-monitoring and Continuous Glucose Monitoring System (CGMS), in absence of signs and symptoms of hyper- or hypo-glycaemia; 2) Reduction of frequency and severity of hypoglycaemic, hyperglycaemic and ketoacidosis episodes; 3) Auxological measurements; 4) The evaluation of general and health related QoL of children and adolescents with T1DM; 5) Adequate insulin requirement; 6) Safety assessments; 7) Pharmacodynamic effects of the two insulin regimens on liver enzymes and lipids� profile; 8) Frequency and severity of skin and systemic insulin � related AEs; 9) Immunogenicity of BIasp70/30; 10) Retinopathy screening; 11) Nephropathy screening; 12) Abdominal ultrasound (for non-alcoholic steatohepatitis). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria will be based on International Society for Pediatric and Adolescent Diabetes (ISPAD) target indicators of glycaemic control and consequent suggested/required actions, e.g.: - Suggested therapeutic intervention for suboptimal glycaemic control (polyuria, polydypsia and enuresis); signs of low blood glucose (episodes of severe hypoglycaemia: unconsciousness or seizures); AM fasting-preprandial plasma glucose (PG) more than 145 mg/dL, post prandial glucose (PPG) 180-250 mg/dL, bedtime PG less than 120 mg/dL or 180-200 mg/dL, nocturnal PG less than 75 or more than 162 mg/dL; blood HbA1c (Diabetes Control and Complications Trial - DCCT standardized) 7.5-9% - Required therapeutic intervention for poor glycaemic control, e.g. blurred vision, poor weight gain, poor growth, delayed puberty, poor school attendance, skin or genital infections, and signs of vascular complications; AM fasting-preprandial PG more than 162 mg/dL, PPG more than 250mg/dL, bedtime PG less than 80mg/dL or more than 200mg/dL, nocturnal PG less than 70 or more than 200mg/dL; HbA1c more than 9%. Subjects with poor compliance or metabolic assessment of ketoacidosis (blood glucose more than 250 mg/dL, pH less than 7.3, HCO3 less than 15mEq/L, glycosuria and ketonuria) requiring IV fluids, insulin and electrolytes replacement will be excluded from the trial |
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E.4 | Principal exclusion criteria |
Inclusion criteria will be based on International Society for Pediatric and Adolescent Diabetes (ISPAD) target indicators of glycaemic control and consequent suggested/required actions, e.g.: - Suggested therapeutic intervention for suboptimal glycaemic control (polyuria, polydypsia and enuresis); signs of low blood glucose (episodes of severe hypoglycaemia: unconsciousness or seizures); AM fasting-preprandial plasma glucose (PG) more than 145 mg/dL, post prandial glucose (PPG) 180-250 mg/dL, bedtime PG less than 120 mg/dL or 180-200 mg/dL, nocturnal PG less than 75 or more than 162 mg/dL; blood HbA1c (Diabetes Control and Complications Trial - DCCT standardized) 7.5-9% - Required therapeutic intervention for poor glycaemic control, e.g. blurred vision, poor weight gain, poor growth, delayed puberty, poor school attendance, skin or genital infections, and signs of vascular complications; AM fasting-preprandial PG more than 162 mg/dL, PPG more than 250mg/dL, bedtime PG less than 80mg/dL or more than 200mg/dL, nocturnal PG less than 70 or more than 200mg/dL; HbA1c more than 9%. Subjects with poor compliance or metabolic assessment of ketoacidosis (blood glucose more than 250 mg/dL, pH less than 7.3, HCO3 less than 15mEq/L, glycosuria and ketonuria) requiring IV fluids, insulin and electrolytes replacement will be excluded from the trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy of either BIAsp70/30 and short-acting insulin/ rapid-acting analogue plus glargine or short-acting insulin/rapid-acting analogue plus glargine on the improvement of metabolic control will be evaluated by means of the percentage of patients with blood HbA1c values of less than 7.5% after 8-week treatment, to be maintained over a 48-week treatment, AND with no changes in body mass index (BMI)-SDS. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | 9 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |