E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 diabetes |
Type 1 diabetes |
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E.1.1.1 | Medical condition in easily understood language |
Type 1 diabetes |
Suikerziekte type 1 |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
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 |
The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine possible differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase. |
Het primaire doel van de studie is om de bètacel-massa bepalen in proefpersonen met type 1 diabetes tijdens en kort na de honeymoonfase, om onderzoek te doen naar de mogelijke verschillen in bètacel-massa and om een beter begrip te krijgen van de verandering in metabole regulatie na de honeymoonfase. |
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E.2.2 | Secondary objectives of the trial |
The secondary aim is to correlate the beta cell mass to the beta cell function from the measurements that will be performed during and shortly after the honeymoon phase. |
Het secundaire doel is om de bètacel-massa te correleren met de bètacel-functie van de metingen die gedaan zijn tijdens en kort na de honeymoonfase. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: - Age ≥16 years - Subject is diagnosed with type 1 diabetes (T1D) - Presence of anti-GAD (glutamic acid decarboxylase) - Subject is in the honeymoon phase of T1D: IDAA1c <9 - 17≤ BMI ≤30 kg/m^2 - Ability to sign informed consent |
Inclusiecriteria: honeymoonfase - Leeftijd ≥16 jaar - Proefpersoon is gediagnosticeerd met type 1 diabetes (T1D) - Aanwezigheid van anti-GAD (glutamic acid decarboxylase) - Proefpersoon bevindt zich in de honeymoonfase van T1D: IDAA1c<9 - 17≤ BMI ≤30 kg/m^2 - Het vermogen om het toestemmingsformulier te ondertekenen |
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E.4 | Principal exclusion criteria |
Exclusion criteria: - Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase lV inhibitors - Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of the normal range - Renal disease defined as MDRD <40 ml/min/1.73 m^2 - Pregnancy or the wish to become pregnant within 6 months after the study - Breastfeeding - BMI <17 kg/m^2 or BMI >30 kg/m^2 - Age <16 years - When the end of the honeymoon phase (IDAA1c ≥9) is not observed within 11 to 13 months after the inclusion of the subject - lnability to sign informed consent |
Exclusiecriteria: - Eerdere behandeling met synthetisch Exendin (Exenatide, Byetta®) of Dipeptidyl-Peptidase lV inhibitors in de afgelopen 6 maanden - Leverziekte, gedefinieerd als een asparaat aminotransferase of alanine aminotransferase waarde van meer dan drie keer de bovengrens van de normaalwaarde - Nierziekte, gedefinieerd als een MDRD <40 ml/min/1.73 m^2 - Zwanger of de wens om zwanger te worden binnen 6 maanden na de studie - Geven van borstvoeding - BMI <17 kg/m^2 of BMI >30 kg/m^2 - Leeftijd <16 jaar - Wanneer het einde van de honeymoonfase (IDAA1c ≥9) niet binnen 11 tot 13 maanden na de inclusie van de proefpersoon wordt waargenomen - Het onvermogen om schriftelijke toestemming te geven |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine the differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase. |
Het primaire doel van de studie is om de bètacel-massa bepalen in proefpersonen met type 1 diabetes tijdens en kort na de honeymoonfase, om onderzoek te doen naar de verschillen in bètacel-massa en om een beter begrip te krijgen van de verandering in metabole regulatie na de honeymoonfase. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 hour after the administration of the tracer (for both scans) |
1 uur na toediening van de tracer (voor beide scans) |
|
E.5.2 | Secondary end point(s) |
The secondary aim is to correlate the beta cell mass to the beta cell function from the measurements that will be performed during and shortly after the honeymoon phase. |
Het secundaire doel is om de bètacel-massa te correleren met de bètacel-functie van de metingen die gedaan zijn tijdens en kort na de honeymoonfase. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the analysis of the mixed-meal tolerance tests and PET/CT scans |
Na de analyse van de maaltijdstimulatietesten en PET/CT scans |
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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 | 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 |
In this study we will determine the beta cell mass as well as the beta cell function in T1D patients during and shortly after the honeymoon phase. This will improve understanding of the change in metabolic control after the honeymoon phase. An increased understanding might provide new insights for the development of novel therapies. (Noting that diagnosis of T1D was already done as stated in the inclusion criteria) |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Herhaalde metingen: proefpersoon is ook de controle (2 metingen voor elke proefpersoon) |
Repeated measures: subject is also the control(2 measurements in each subject) |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 2 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |