E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | Type 1 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years |
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E.2.2 | Secondary objectives of the trial |
To assess the effects of insulin glargine compared to NPH insulin over 24 weeks: ◦Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c < 7.5%,
◦Fasting blood glucose (FBG),
◦Nocturnal blood glucose (BG),
◦24-hour blood glucose profile based on 8-point self-monitoring of blood glucose values,
◦Daily total insulin dose and basal insulin dose,
◦Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia.
•To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs).
•To assess anti-insulin and anti-glargine antibody development in both groups.
•To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Paediatric patients diagnosed with type 1 diabetes melitus (T1DM) aged at least 6 years to less than 18 years at screening. |
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E.4 | Principal exclusion criteria |
Treatment with oral or parenteral glucose-lowering medications other than insulin. HbA1c < 7% or > 12 % at screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Absolute change of glycosylated hemoglobin (HbA1c) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Percentage of patients reaching HbA1c < 7.5% -
Change in Fasting Blood Glucose (FBG)
Change in nocturnal Blood Glucose (BG)
Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)
Change in total insulin dose and basal insulin dose
Rate of asymptomatic and/or symptomatic, severe, nocturnal,
nocturnal symptomatic hypoglycemia
Anti-glargine and anti-human insulin antibody assessment
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At week 24
Percentage of patients reaching HbA1c < 7.5% -
From baseline to week 24
Change in Fasting Blood Glucose (FBG)
Change in nocturnal Blood Glucose (BG)
Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)
Change in total insulin dose and basal insulin dose
during 24-week treatment period
Rate of asymptomatic and/or symptomatic, severe, nocturnal,
nocturnal symptomatic hypoglycemia
at screening
Anti-glargine and anti-human insulin antibody assessment
at week 4
Anti-glargine and anti-human insulin antibody assessment
at week 24
Anti-glargine and anti-human insulin antibody assessment
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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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA 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.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |