E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 Diabetes |
Typ 1 Diabetes |
|
E.1.1.1 | Medical condition in easily understood language |
Type 1 Diabetes |
Typ 1 Diabetes |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012601 |
E.1.2 | Term | 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. |
Der Zweck dieser klinischen Studie ist die Bestimmung der 68GaNODAGA-exendin 4 Aufnahme im Pankreas um intraindividuelle Unterschiede bei der Diagnose mit Typ 1 Diabetes und 1 Jahr später aber auch interindividuelle Unterschiede zwischen Patienten unter Verapamil oder Placebo-Therapie. |
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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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- Unterschiede zwischen die Traceranreicherung im Pankreas zu Änderungen in C-Peptid sowie Preproinsulin Plasmakonzentrationen zu untersuchen. - Unterschiede zwischen intraindividuelle 68Ga-NODAGA-exendin Anreicherung aber auch interindividuelle Anreicherung an den 2. Bildgebungszeitpunkte um zukünftige Stichprobengröße-Rechnungen durchzuführen. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Have given written informed consent - Are aged between 18 and 45 years old - Are included in the VER-A-T1D trial
|
- Eine Einwilligungserklärung wurde unterschrieben - Alter zwischen 18 und 45 Jahre - Sind in der VER-A-T1D Studie inkludiert |
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E.4 | Principal exclusion criteria |
- 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 months after second PET/CT scan.
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- Therapie mit exendin (Exentide, Byetta®) oder Dipeptidyl-Peptidase IV Hemmer (um Interferenzen mit der Bildgebung zu exkludieren) - Nierenerkrankungen mit einen MDRD < 40 ml/min/1.73m2 - Schwangerschaft oder der Wunsch Schwanger 2 Monate nach der 2. PET/CT Untersuchung zu werden |
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E.5 End points |
E.5.1 | Primary end point(s) |
The total pancreatic uptake of 68Ga-NODAGA-exendin for determination of beta cell mass at the point of inclusion and after 12 months. |
Die 68Ga-NODAGA-exendin 4 Anreicherung im Pankreas um die Menge der Beta-Zell Masse bei der Diagnose und 12 Monate später zu bestimmen. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the second scan (12 months into treatment) |
Nach dem 2. 68Ga-NODAGA-exendin 4 PET/CT Scan (12 Monate nach Therapiestart) |
|
E.5.2 | Secondary end point(s) |
- Changes in 68Ga-NODAGA-exendin pancreas uptake in realtion 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 timepoints of imaging intra-individually
|
- Korrelationen zwischen der 68Ga-NODAGA-exendin 4 Anreicherung im Pankreas und Änderungen in C-Peptid Plasmakonzentrationen zu untersuchen. - Korrelationen zwischen der 68Ga-NODAGA-exendin 4 Anreicherung im Pankreas und Änderungen in Proinsulin/Preproinsulin Plasmakonzentrationen zu untersuchen. - Unterschiede zwischen der 68Ga-NODAGA-exendin 4 Anreicherung im Pankreas zu den verschiedenen Zeitpunkte zu untersuchen. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the second scan (12 months into treatment) |
Nach dem 2. 68Ga-NODAGA-exendin 4 PET/CT Scan (12 Monate nach Therapiebeginn) |
|
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 | 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 | 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 | 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 | Yes |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |