E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 Diabetes mellitus
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Type 1 Diabetes mellitus
|
|
E.1.1.1 | Medical condition in easily understood language |
Type 1 Diabetes mellitus
|
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 |
The main objective is to determine the feasibility of dasiglucagon in the Inreda AP-system. |
Het belangrijkste doel is om de haalbaarheid van dasiglucagon in het Inreda AP-systeem te bepalen. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess safety parameters, differences in pharmacodynamics between dasiglucagon and GlucaGen® and differences in AP related outcomes. |
Secundaire doelen zijn het beoordelen van veiligheidsparameters, verschillen in farmacodynamiek tussen dasiglucagon en GlucaGen en verschillen in AP-gerelateerde uitkomsten. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Diagnosed with diabetes mellitus type 1; • Treated with the Inreda AP system for a minimum of 1 month; • Age between 18 and 75 years; • Adequate contraception is required (only applicable for female participants);
|
• Gediagnosticeerd met diabetes mellitus type 1; • Behandeld met de Inreda AP voor minimaal 1 maand; • Leeftijd tussen de 18 en 75 jaar; • Adequate contraceptie is verplicht voor vrouwen; |
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E.4 | Principal exclusion criteria |
• Impaired awareness of hypoglycemia • Pregnancy and/or breastfeeding; • Use of oral antidiabetic agents; • Pheochromocytoma; • Insulinoma; • Severe liver/heart/renal failure; • Alcohol abuse; • Hypersensitivity reactions to dasiglucagon. |
• Hypounaware; • Zwangerschap en/of borstvoeding; • Gebruik van orale antidiabetici middelen; • Pheochromocytoma; • Insulinoma; • Ernstig lever, hart, nier falen; • Alcohol verslaving; • Hypersensitief voor dasiglucagon. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Main parameter to express feasibility is the time in range (3.9 – 10.0 mmol/l), which will be compared between the dasiglucagon and reference glucagon. |
De belangrijkste parameters om de haalbaarheid uit te drukken, is de tijd dat de bloedglucosewaardes binnen bereik zijn (3,9 - 10,0 mmol / l), die zal worden vergeleken tussen dasiglucagon en GlucaGen. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of the study |
Einde van de studie |
|
E.5.2 | Secondary end point(s) |
Safety will be expressed as side effects of dasiglucagon compared to side effects of GlucaGen.
Pharmacodynamics will be expressed in proportion of time spent in hypo-/hyperglycemia, median/mean glucose value, glycemic variability and PD curves, which will all be compared between the dasiglucagon and reference glucagon.
AP related outcomes will be expressed in daily administered (maintenance) dosage of insulin/glucagon. |
Veiligheid zal worden uitgedrukt in bijwerkingen van dasiglucagon in vergelijking met de bijwerkingen van GlucaGen.
De farmacodynamiek zal worden uitgedrukt in tijd besteed inhypo- / hyperglycemie, mediane / gemiddelde glucosewaarde, glykemische variabiliteit en PD-curves, die allemaal zullen worden vergeleken tussen de dasiglucagon en referentieglucagon.
AP-gerelateerde uitkomsten die bepaald worden zijn dagelijks toegediende (onderhouds)dosering van insuline / glucagon. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of the study |
Einde van de studie |
|
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 | No |
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) | Yes |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |