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PRA-RPUBLI41-0H20OM

Type 2 diabetes

  • M/F
  • 18 - 65 years old
  • Healthy

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

  • From December 2024
  • 20 days
  • 4 visits

€5600,-

Everything was well organized!

 

Josine

Deelnemer ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 65 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 18 and 32 kg/m2

Good to know about this trial

  • The study compound has been administered to people before 
  • The study consists of two parts; you can only participate in one of them
  • The study compound is given as a capsule and/or as a tablet

 

How does it work

How does it work?

Read more

Study groups

Register without obligation for the group of your preference

The research physician about this research

Additional information

  • The study compound is being developed for the treatment of diabetes type 2 and has been administered to healthy people before in a previous clinical trial. In type 2 diabetes, too much sugar remains in the blood because the body no longer responds properly to insulin. Insulin is the hormone that regulates blood sugar levels.
  • In this study we investigate whether approved compounds that are already available on the market (itraconazole, gemfibrozil, and cyclosporine) have an influence on the way the  study compound is processed and eliminated by the body and how well the combination of the study compound and the other compounds is tolerated when it is used by healthy participants. Itraconazole is used to treat fungal infections, gemfibrozil is used to treat high cholesterol, and cyclosporine is used to treat psoriasis.
  • The trial consists of 2 parts:
  • In part 1, you receive two times a single dose of the study compound. This will be administered in the form of a capsule to swallow. In the first period you will receive a single dose of the study compound once. In the second period you will receive a single dose of the study compound once, and you will also receive itraconazole. This will also be administered in the form of a capsule to swallow. You will receive itraconazole once or twice daily for 12 days.
  • In part 2, you receive four times a single dose of the study compound. This will be administered in the form of a capsule to swallow. In the first period you will receive a single dose of the study compound once. In the second period you will receive a single dose of the study compound once, and you will also receive gemfibrozil in the form of a tablet to swallow. You will receive gemfibrozil twice daily for 5 days. In the third and fourth period you will receive a single dose of the study compound once, and you will also receive cyclosporine in the form of a capsule to swallow. You will receive cyclosporine once in both period three and four.
  • Only for part 2: Based on the results of the first 2 periods, it could be decided period 3, and/or period 4 will not take place.

Who can participate?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 65 years old.
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18 and at most 32 kg/m2. 
  • Both non-smokers and light or occasional smokers are allowed to participate in this clinical trial (maximum of 5 cigarettes per day). During your stay in our research facility you are not allowed to smoke.
  • 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) and you use a condom;
      • You are not sexually active according to your lifestyle;
      • You are only sexually active with a partner of the same sex.

Note: You cannot participate in the trial if you have participated in another clinical trial in the 90 days prior to the first compound administration in this clinical trial (counting from the follow-up visit). This might be longer for certain trials, please contact us for more information.

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.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

You will receive a gross compensation of € 5600 for participation in one of the groups of part 1. For participation in one of the groups of part 2 of the trial, you will receive a gross compensation of € 6902. Only for part 2: if it is decided that period 3 and 4 are not necessary, you will receive a gross compensation of € 5371. If it is decided that period 4 is not necessary, you will receive a gross compensation of € 6136.50. 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 2 parts: part 1 and part 2. You can only participate in one group of this trial.

Part 1 consists of 2 periods during which you will stay each period in the research facility in Groningen (location van Swietenlaan 6). The first period you will stay in the research facility for 6 days (5 nights), followed by one short visit. The second period you will stay in the research facility for 14 days (13 nights), followed by 3 short visits. The follow-up visit will take place 4 to 8 days after your last short visit.

Part 2 consists of 4 periods during which you will stay each period in the research facility in Groningen (location van Swietenlaan 6). The first period you will stay in the research facility for 6 days (5 nights), followed by one short visit. The second period you will stay in the research facility for 8 days (7 nights), followed by 1 short visit. The third period you will stay in the research facility for 6 days (5 nights), followed by 1 short visit. The fourth period you will stay in the research facility for 6 days (5 nights), followed by 1 short visit. The follow-up visit will take place 9 to 13 days after your last short visit.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.

Frequently asked questions

You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.

 

During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.

Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.

Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!

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