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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 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 safety and tolerability of 0.3, 0.6, 0.9, 1.2 and 1.8 mg doses of liraglutide in the paediatric population (10 – 17 years of age).
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E.2.2 | Secondary objectives of the trial |
• To estimate the pharmacokinetic (PK) parameters of liraglutide in children
• To estimate the pharmacodynamic (PD) parameters of liraglutide in children
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Signed informed consent
• Male and female subjects with type 2 diabetes
• Age – pediatric: 10-17 years (both inclusive)
• BMI: > 85th percentile for age and gender (pediatric)
• Drug-naïve (diet/exercise) or treated with metformin, stable dose and dosing frequency for at least 4 weeks prior to screening with HbA1c ≥ 6.5% and ≤ 11.0%
• Good general health based on medical history and physical examination including ECG and routine laboratory analysis
• At randomization: FPG ≥110 – ≤ 240 mg/dL (≥ 6.1 mmol/L and ≤ 13.3mmol/L) |
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E.4 | Principal exclusion criteria |
• Presence of any clinically significant disease or medical history (other than type 2 diabetes)
• Type 1 diabetes
• Previous treatment within last three months with any antidiabetic agent other than metformin (except for prior short term treatment with insulin, at the discretion of the investigator and if given more than 1 month before the first dose)
• Female of childbearing potential/breast feeding, pregnant, intent to become pregnant or not using adequate contraception |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability throughout the trial
Laboratory safety (including plasma glucose, haematology, clinical chemistry and urinalysis), physical examination, vital signs, electrocardiogram (ECG), funduscopy, liraglutide antibodies, hypoglycaemic events and adverse events will be reported. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | Yes |
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) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 16 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 28 |