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 main study objective is to measure residual beta cell mass, indicated by the pancreatic uptake of 68Ga-exendin using quantitative PET, in T1D patients with stable near-normal and unstable glucose control, to improve understanding of the relation between residual beta cell mass and glycemic control. |
Het primaire doel is om residuele bètacel-massa te meten, aangegeven door de uptake van 68Ga-exendin in het pancreas gebruikmakend van kwantitatieve PET, in T1D patiënten met een stabiele vrijwel normale en onstabiele glucoseregulatie, om een beter begrip te krijgen van de relatie tussen residuele bètacel-massa en glycemische regulatie. |
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E.2.2 | Secondary objectives of the trial |
The secondary aim is to correlate the measured residual beta cell mass to the beta cell function that will be determined by a mixed-meal tolerance test. |
Het secundaire doel is om de gemeten residuele bètacel-massa te correleren met de bètacel-functie, die bepaald zal worden door een maaltijdstimulatietest. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
lnclusion criteria: T1D patients with stable near-normal glucose control: - Age ≥18 years - T1D diagnosed ≥1 year at the start of the study - HbA1c <7 (<53 mmol/mol) - 17≤ BMI ≤30 kg/m^2 - No severe hypoglycemic events in the past year and a maximum of 2 severe hypoglycemic events in their entire life. - lntact hypoglycemic awareness as assessed by a score of 0 or 1 on the modified Clarke's questionnaire - Ability to sign informed consent
lnclusion criteria: T1D patients with unstable glucose control: - Age ≥18 years - T1D diagnosed ≥1 year at the start of the study - HbA1c >8.5 (>69 mmol/mol) - 17≤ BMI ≤30 kg/m^2 - Minimum of 2 severe hypoglycemic events in the past year or an impaired awareness of hypoglycemia (IHA), as assessed by a score of 3 or more on the modified Clarke's questionnaire (subjects may comply with both criteria, but this is not a requirement) - Ability to sign informed consent |
lnclusiecriteria: T1D patiënten met stabiele vrijwel normale glucose regulatie: - Leeftijd ≥18 jaar - T1D diagnose ≥1 jaar bij de start van de studie - HbA1c <7 (<53 mmol/mol) - 17≤ BMI ≤30 kg/m^2 - Geen ernstige hypoglycemische voorvallen in het afgelopen jaar en een maximum van 2 ernstige hypoglycemische voorvallen tijdens het gehele leven - lntact hypoglycemisch bewustzijn, beoordeeld met een score van 0 of 1 op de aangepaste Clarke's questionnaire - Het vermogen om het toestemmingsformulier te tekenen
lnclusiecriteria: T1D patiënten met onstabiele glucose regulatie: - Leeftijd ≥18 jaar - T1D diagnose ≥1 jaar bij de start van de studie - HbA1c >8.5 (>69 mmol/mol) - 17≤ BMI ≤30 kg/m^2 - Minimum van 2 ernstige hypoglycemische voorvallen in het afgelopen jaar of een verminderd hypoglycemisch bewustzijn, beoordeeld met een score van 3 of meer op de aangepaste Clarke's questionnaire (proefpersonen mogen aan beide criteria voldoen, maar dit is geen vereiste) - Het vermogen om het toestemmingsformulier te tekenen |
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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 <18 years - 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 <18 jaar - Het onvermogen om schriftelijke toestemming te geven |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study objective is to determine residual beta cell mass in T1D patients with stable near-normal and unstable glucose control, as determined by measuring pancreatic uptake of Ga-68-exendin-4, to gain a better understanding of the relation between residual beta cell mass and glycemic control. |
Het primaire doel van de studie is om de residuele bètacel-massa te bepalen met behulp van Ga-68-exendin PET, bij type 1 diabetes patiënten met stabiele vrijwel normale glucoseregulatie en instabiele glucoseregulatie, om een beter begrip krijgen van de relatie tussen residuele bètacel-massa en glycemische regulatie. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 hour after the administration of the tracer |
1 uur na toediening van de tracer |
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E.5.2 | Secondary end point(s) |
The secondary aim is to correlate the measured residual beta cell mass to the beta cell function that will be determined by a mixed-meal tolerance test. |
Het secundaire doel is om de gemeten residuele bètacel-massa aan de bètacel-functie te correleren, de bètacel-functie zal bepaald worden met een maaltijdstimulatie test. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the analysis of the mixed-meal tolerance test and PET/CT scan |
Na de analyse van de maaltijdstimulatietest en PET/CT scan |
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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 with a different glycemic control. This will give more insight in the relation between beta cell function and mass, which will aid in the selection of patients for innovative treatment aimed at improving beta cell function. 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 | Yes |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Controlegroep: T1D patiënten met stabiele vrijwel normale glucoseregulatie |
Control group: T1D patients with stable near-normal glucose control |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |