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PRA-FO8BIA84-0D1VAE

Diabetes type 2

  • M/F
  • 18 - 55 years old
  • Non-smoker
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of type 2 diabetes

Register without obligation

Hele positieve ervaring. Je wordt stap voor stap goed begeleid door het traject.

Maura

Deelnemer ICON

Register without obligation

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 55 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2
  • Non-smoker

Good to know about this trial

  • The study compound is given to you as capsules that you take with a glass of water
  • The medical screening can take place in both Groningen and Utrecht
  • The study compound has previously been administered to humans

 

How does it work

How does it work?

  1. 1.

    Registering

    Register for the trail and the group you choose. After your registration, call ICON to discuss the study and make an appointment for your medical examination. This can be done from the next working day after your registration.

  2. 2.

    Medical screening

    If you meet the requirements of the trial, then a medical screening takes place at our screening center in Groningen or Utrecht.

  3. 3.

    The trial

    The clinical trial is conducted at ICON's research center in Groningen. There you will eat, sleep and stay during the trial.

  4. 4.

    Follow-up & Compensation

    A follow-up screening always takes place after the trial. You will receive the compensation for your participation, within 30 days.

Read more

Study groups

Register without obligation for the group of your preference

  • Group 1

    • 8 July up to and including 6 August

    Period(s) of stay (30 days)

    • 8 July up to and including 6 August

    • €8234,- to €9549,-

    Compensation

    • €8234,- to €9549,-

    Please note: there are possible 24-hour visits on: 11-12, 18-19 August, 01-02, 15-16, 29-30 September 2024. See 'period research' for more information.

    24-hour visits

    Please note: there are possible 24-hour visits on: 11-12, 18-19 August, 01-02, 15-16, 29-30 September 2024. See 'period research' for more information.

    Full

  • Group 1a

    • 11 July up to and including 9 August

    Period(s) of stay (30 days)

    • 11 July up to and including 9 August

    • €8234,- to €9549,-

    Compensation

    • €8234,- to €9549,-

    Please note: there are possible 24-hour visits on: 14 - 15, 21 - 22 August, 04 - 05, 18 - 19 September, 02 - 03 October 2024. See 'period research' for more information.

    24-hour visits

    Please note: there are possible 24-hour visits on: 14 - 15, 21 - 22 August, 04 - 05, 18 - 19 September, 02 - 03 October 2024. See 'period research' for more information.

    Full

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

  • People with type 2 diabetes have too much sugar in their blood and need treatment to keep their sugar level under control. The study compound may potentially be used for this treatment. The compound acts like a hormone that occurs naturally in the body. This hormone helps people feel full and helps to lower blood sugar levels. Some drugs that act this way are already approved and being used to treat people living with diabetes
  • This is a clinical trial with a radioactive (14C) labeled compound. Radioactive labeling a compound is done to be able to study how quickly and to what extent the compound is absorbed, converted and excreted in the body. The radioactivity disappears from the body at the same time as the compound through the feces, urine and/or breath. In this study a very small radioactive dose will be used which has a negligible radiation burden To measure radioactivity levels in your body, blood, urine and feces will be collected during the trial.
  • During this study you will be in the research center for a maximum of 30 days. During the period of stay you will take the study compound as capsules by mouth once daily from day 1 to day 20. On day 21, you will receive the study compound as a solution to drink.

WHO CAN PARTICIPATE IN THIS TRIAL?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 55 years old.
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m2. 
  • Only non-smokers are allowed to participate in this clinical trial (minimum 3 months non-smoking).

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit of the previous trial).
  • You can only participate in this trial if you have not participated in another trial with a radioactive (14C) labeled compound in the past 12 month. For a microtracer study the timeframe is 30 days. Please contact us to see if this is applicable for you.
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.
  • As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
    • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
    • You are using a copper intra-uterine device in combination with a condom;
    • You have passed the menopause (no periods for at least 12 months);
    • You have been sterilized or your male partner has been sterilized;
    • You are not sexually active according to your lifestyle;
    • You are only sexually active with a partner of the same sex.
  • As a male you can only participate if you meet one of the following conditions:
    • You are using a condom in combination with an additional contraception method used by your female partner;
    • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
    • You are not sexually active according to your lifestyle;
    • You are only sexually active with a partner of the same sex.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

You will receive a gross compensation of € 8234 for participation in this study. In case there are one or more 24-hour additional visits needed, you will receive a gross compensation of €263 for each visit.

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176,40 (840 kilometers) per round trip, regardless of the mode of transportation.

HOW LONG DOES THIS RESEARCH TAKE?

Period of stay and research

The trial consists of one period of stay during which you will stay in the research facility in Groningen (location van Swietenlaan 6 for a minimum of 24 days (23 nights) and a maximum of 30 days (29 nights). Depending on the radioactivity levels in your body at the end of the period of stay you may have to return to the research facility for a maximum of five 24-hour visits, until radioactivity levels are low enough. If you don’t have to return for a 24-hour visit a follow-up visit will take place within 7 days after departure from the research facility. Otherwise this will take place within 7 days after the last 24-hour visit you have at the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial.

Veelgestelde vragen

Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.

Je kunt tijdens het onderzoek last krijgen van milde klachten als hoofdpijn of misselijkheid. Dat kan door het geneesmiddel komen. Maar het kan ook komen doordat je voor het onderzoek bijvoorbeeld nuchter moet blijven. Die bijwerkingen zijn vervelend, maar gelukkig niet gevaarlijk.

Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.

Je deelname aan geneesmiddelenonderzoek is altijd vrijwillig. Je mag dus op elk moment besluiten om te stoppen. Soms ben je genoodzaakt om te stoppen. Bijvoorbeeld vanwege familieomstandigheden, of als de arts besluit dat dat voor jouw gezondheid beter is. Als je stopt, bekijken we op welk deel van de vergoeding je recht hebt. Wel zo eerlijk!

Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.

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