DM1 MedDRA version: 9.1 Level: SOC Classification code 10014698
Conditions
Interventions
Trade Name: NOVOMIX 70*FLEX 5PEN 3ML 100U/
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Insulin aspart
Concentration unit: IU/ml international unit(s)/millilitre
Concentration ty
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
All
Inclusion criteria
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 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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).;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. | — |
Countries
Italy
Outcome results
None listed