E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 2 |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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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 the efficacy of insulin detemir in combination with metformin and diet/exercise versus insulin Neutral Protamine Hagedorn (NPH) in combination with the max. tolerated dose (MTD) of metformin and diet/exercise in controlling glycaemia, after 26 weeks of treatment, in children and adolescents (aged 10–17 years) with type 2 diabetes (T2D), who are insufficiently treated with the MTD of metformin ± other OAD(s) ± basal insulin. |
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E.2.2 | Secondary objectives of the trial |
In children and adolescents (aged 10–17 years) with T2D insufficiently treated with the MTD of metformin ± other OAD(s) ± basal insulin:
1. To compare the efficacy of insulin detemir in combination with the MTD of metformin and diet/exercise vs. insulin NPH in combination with the MTD of metformin and diet/exercise on body weight, after 26 weeks' treatment
2. To compare the proportion of subjects achieving glycaemic control without experiencing severe hypoglycaemia, after 26 weeks' treatment, for insulin detemir in combination with the MTD of metformin and diet/exercise vs. insulin NPH in combination with the MTD of metformin and diet/exercise
3. To assess and compare the safety and tolerability of insulin detemir in combination with the MTD of metformin and diet/exercise vs. insulin NPH in combination with the MTD of metformin and diet/exercise, during 26 weeks' treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent from the subject or a legally acceptable representative (LAR) and child assent from the subject obtained before
any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial XML File Identifier: xz03n7mDeeRWhsZnwdHjlWpab9U=Page 15/26
2. Male or female, 10 years ≤ age ≤17 years at the time of signing informed consent/assent
3. Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
4. Treated with the maximum tolerated stable dose of metformin for at least 3 months prior to screening or have documented complete metformin intolerance. Note other OADs and basal insulin are allowed; bolus insulin is only allowed as rescue treatment for a maximum of 7 days for the last 3 months prior to screening
5. HbA1c; ≥ 7.0% and ≤ 10.5% (≥ 53 mmol/mol and ≤ 91 mmol/mol) at screening |
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E.4 | Principal exclusion criteria |
1. Maturity onset diabetes of the young (MODY)
2. Fasting C-peptide at screening <0.6 ng/mL
3. Impaired liver function defined as alanine aminotransferase (ALT) ≥ 2.5 times upper normal limit
4. Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
5. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 3 months before the day of screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) |
1. Change in body weight standard deviation score (SDS)
2. Proportion of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment
3. Proportion of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment
4. Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes
5. Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes
6. Incidence of adverse events (AEs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. From baseline to Week 26
2. - 3. At Week 26
4. - 6. During 26 weeks of treatment |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
Argentina |
Brazil |
Canada |
China |
Egypt |
European Union |
India |
Israel |
Japan |
Lebanon |
Macedonia, the former Yugoslav Republic of |
Malaysia |
Mexico |
Morocco |
Russian Federation |
Serbia |
South Africa |
Taiwan |
Turkey |
United States |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 15 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 15 |