E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes |
Type 2 diabetes |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Suikerziekte type 2 |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
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 study parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment. |
Het primaire doel van de studie is de vergelijking van de hypofyse-opname van 68Ga-NODAGA-exendin in patiënten met en zonder adequate respons (gebaseerd op HbA1c of gewichtsverlies) op GLP-1R agonist behandeling. |
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E.2.2 | Secondary objectives of the trial |
To assess the metabolic status of the patients by obtaining laboratory parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary cortisol excretion tests. |
De metabole status van patiënten te bepalen door middel van laboratoriumwaarden, een orale glucose tolerantie test, gestimuleerde ACTH-test en cortisolbepalingen in de urine. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria (patients with treatment response) - Age ≥18 years - Subject is diagnosed with type 2 diabetes - Subject showed response to GLP-1RA treatment (decrease in HbA1c ≥5 mmol/mol and/or weight loss ≥5%) - Ability to sign informed consent
Inclusion criteria (patients without treatment response) - Age ≥18 years - Subject is diagnosed with type 2 diabetes - Subject showed no response to GLP-1RA treatment (decrease in HbA1c <5 mmol/mol and no weight loss) - Ability to sign informed consent |
Inclusiecriteria (patiënten met respons op behandeling) - Leeftijd ≥18 jaar - Deelnemer is gediagnosticeerd met type 2 diabetes - Deelnemer laat een respons op GLP-1RA behandeling zien (afname in HbA1c ≥5 mmol/mol en/of gewichtsverlies ≥5%) - Het vermogen om het toestemmingsformulier te ondertekenen
Inclusiecriteria (patiënten zonder respons op behandeling) - Leeftijd ≥18 jaar - Deelnemer is gediagnosticeerd met type 2 diabetes - Deelnemer laat geen respons op GLP-1RA behandeling zien (afname in HbA1c <5 mmol/mol en geen gewichtsverlies) - Het vermogen om het toestemmingsformulier te ondertekenen |
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E.4 | Principal exclusion criteria |
Exclusion criteria: - 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 - Age <18 years - Pituitary disorder - lnability to sign informed consent |
Exclusiecriteria: - 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 - Leeftijd <18 jaar - Aandoening van hypofyse - 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 parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment. |
Het primaire doel van de studie is de vergelijking van de hypofyse-opname van 68Ga-NODAGA-exendin in patiënten met en zonder adequate respons (gebaseerd op HbA1c of gewichtsverlies) op GLP-1R agonist behandeling |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1.5 hour after the administration of the tracer |
1.5 uur na toediening van de tracer |
|
E.5.2 | Secondary end point(s) |
To assess the metabolic status of the patients by obtaining laboratory parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary cortisol excretion tests. |
De metabole status van patiënten te bepalen door middel van laboratoriumwaarden, een orale glucose tolerantie test, gestimuleerde ACTH-test en cortisolbepalingen in de urine. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the analysis of all tests and PET/CT scan |
Na de analyse van alle testen 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 compare the pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment, to increase understanding of the role of the HPA axis in T2D that could contribute to the improvement and development of novel treatment strategies (noting that diagnosis of T2D 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 |
2 patiënten groepen: 1 groep liet een behandelingseffect zien, de tweede groep niet |
2 patient groups: 1 group showed treatment response, the second group showed no adequate response |
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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 | 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 | 3 |
E.8.9.1 | In the Member State concerned days | |