E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 diabetes mellitus |
Type 1 diabetes mellitus |
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E.1.1.1 | Medical condition in easily understood language |
Diabetes type 1 |
Suikerziekte type 1 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
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 determine the efficacy of Lyumjev in the Inreda artificial pancreas (AP) system |
Om de werkzaamheid van Lyumjev in de Inreda kunstmatige alvleesklier te bepalen |
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E.2.2 | Secondary objectives of the trial |
To assess safety parameters, and differences in pharmacodynamics and AP-related outcome measures |
Vaststellen van veiligheidsparameters, en verschillen in farmacodynamiek en AP-gerelateerde uitkomstmaten |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Diagnosed with type 1 diabetes mellitus; • Treated with the Inreda AP system for a minimum of 1 month; • Age between 18 and 75 years; • Willing and able to sign informed consent |
- Gediagnosticeerd met type 1 diabetes mellitus - Ondergaat behandeling met Inreda AP systeem voor minimaal 1 maand - Leeftijd tussen 18 en 75 jaar - Bereid en bekwaam om informed consent te tekenen
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E.4 | Principal exclusion criteria |
• Impaired awareness of hypoglycemia (score ≥4) according to the Gold and/or Clarke questionnaire; • Pregnancy and/or breastfeeding; • Use of oral antidiabetic agents; • Insulinoma; • Hypersensitivity reactions to Lyumjev insulin or any of the excipients; • Any condition that the local investigator feels would interfere with study participation or evaluation of the results.
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- Verminderd bewustzijn van hypoglykemie (score ≥4) volgens Gold and/or Clarke vragenlijst - Zwangerschap en/of borstvoeding - Gebruik van orale antidiabetica - Insulinoom - Hypersensitieve reactie op Lyumjev of andere hulpstoffen - Elke aandoening waarvan de lokale onderzoeker denkt dat het zou interfereren met studiedeelname of evaluatie van de resultaten |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is the efficacy of Lyumjev in the AP. Main parameter to express efficacy is the time above range (>10 mmol/l). It is hypothesized that the time above range is lower using Lyumjev compared to the standard use of care: Humalog. |
Het primaire eindpunt is de werkzaamheid van Lyumjev in de AP. De hoofdparameter om de werkzaamheid in uit te drukken is de tijd boven het streefbereik (>10 mmol/L). De hypothese is dat de tijd boven streefbereik lager is met Lyumjev dan met de standaard gebruikte insuline (Humalog) in de AP. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study |
Einde van de studie |
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E.5.2 | Secondary end point(s) |
To assess safety parameters, and differences in pharmacodynamics and AP-related outcome measures |
Vaststellen van veiligheidsparameters, en verschillen in farmacodynamiek en AP-gerelateerde uitkomstmaten |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of study |
Einde van de studie |
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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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
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 | No |
E.8.1.6 | Cross over | Yes |
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 | 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 | No |
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.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |