E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 diabetes mellitus |
Diabète sucré de type 1 |
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E.1.1.1 | Medical condition in easily understood language |
Type 1 Insulin-dependent diabetes |
Diabète insulinodépendant de 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 | 21.1 |
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 |
To measure pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for detection of intra-individual differences in beta cell mass before and after treatment and inter-individual differences between the treatment group and the placebo group. |
Mesurer en TEP/TDM la fixation de 68Ga-NODAGA-exendine-4 par les cellules bêta pancréatiques à la recherche de différences intra-individuelles de la masse des cellules bêta avant et après le traitement et de différences interindividuelles entre le groupe avec traitement actif et le groupe placebo |
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E.2.2 | Secondary objectives of the trial |
To compare changes in pancreatic 68Ga-NODAGA-exendin uptake to changes in C-peptide and proinsulin/preproinsulin measurements.
To quantify the differences in 68Ga-NODAGA-exendin uptake between individuals and between the two time points of imaging intra-individually for future calculations of study group sizes.
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Comparer les changements dans la fixation pancréatique de 68Ga-NODAGA-exendine-4 aux changements de concentration sérique du peptide C et de la proinsuline / préproinsuline.
Quantifier les différences de fixation de 68Ga-NODAGA-exendine-4 entre les individus et entre l'imagerie avant et après le traitement pour chaque individu. Ces données seront utiles pour les calculs de la taille des groupes lors de futures études.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient: Are included in the Ver-A-T1D trial, but have not started treatment/placebo. Have given written informed consent. Age ≥18 years at consent
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Patient : Inclus dans l'essai Ver-A-T1D, mais n'a pas commencé de traitement / placebo A donné son consentement éclairé par écrit Âge ≥ 18 ans au moment du consentement
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E.4 | Principal exclusion criteria |
(additional to Ver-A-T1D): -Treatment with synthetic exendin (Exentide, Byetta®) or dipeptidyl-peptidase IV inhibitors (to exclude interferences with imaging), specifically mentioned although in principle part of exclusion criteria Ver-A-T1D. - Renal disease defined as MDRD < 40 ml/min/1.73m2 - Pregnancy or the wish to become pregnant within 2 month after the second PET/CT scan.
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Critères d'exclusion (en plus de ceux de l’étude Ver-A-T1D) :
- Traitement par inhibiteurs de l'exendine synthétique (Exentide, Byetta®) ou de la dipeptidyl-peptidase IV (pour exclure les interférences avec l'imagerie), bien qu'en principe ce soit aussi des critères d'exclusion pour l’étude Ver-A-T1D. - Maladie rénale définie par une clairance glomérulaire <40 mL / min / 1,73 m2 selon la formule MDRD - Grossesse ou souhait de grossesse dans les deux mois suivant la deuxième TEP / TDM.
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E.5 End points |
E.5.1 | Primary end point(s) |
Measure the total pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for determination of beta cell mass at the point of inclusion and after 12 months. |
Mesurer la fixation pancréatique totale de 68Ga-NODAGA-exendine-4 pour la détermination de la masse cellulaire bêta à l'inclusion et après 12 mois |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessment before inclusion in the Ver-A-T1D study and at the end of the study after 12 months of treatment. |
Évaluation avant l'inclusion dans l'étude Ver-A-T1D et après 12 mois de traitement. |
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E.5.2 | Secondary end point(s) |
- Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in C-peptide measurements - Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in proinsulin/preproinsulin measurements. - Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two time points of imaging intra-individually
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- Modifications de la fixation du 68Ga-NODAGA-exendine-4 par le pancréas en relation avec les modifications de la concentration sérique du peptide C - Modifications de la fixation de 68Ga-NODAGA-exendine-4 dans le pancréas en relation avec les modifications de la concentration sérique de la proinsuline / préproinsuline. - Différences de fixation de 68Ga-NODAGA-exendine-4 entre les individus et entre les deux moments d’acquisition des images . |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Assessment before inclusion in the Ver-A-T1D study and at the end of the study after 12 months of treatment. |
Évaluation avant l'inclusion dans l'étude Ver-A-T1D et après 12 mois de traitement. |
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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 | Yes |
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 | 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) | 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 | 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 | 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 | No |
E.8.2.3 | Other | No |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | No |
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 | 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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LVLS |
La dernière visite du dernier patient |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |