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RO0165-1261-GRQ

Diabetes type 2

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

Geneesmiddelenonderzoek naar een nieuw middel dat is ontwikkeld voor de behandeling van type 2 diabetes en gewichtsbeheersing

  • From November 2025
  • 56 days (Spread over several periods)

€9274,- to €12842,-

Very relaxed place. Very pleasant employees.

Katharina

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 23 and 32 kg/m2

Good to know about this trial

  • Het middel is al onderzocht bij gezonde personen en patiënten met diabetes type 2
  • Het onderzoek bestaat uit 3 periodes waarbij je de eerste twee periodes minimaal 17 dagen (16 nachten) en maximaal 25 dagen (24 nachten) in het onderzoekscentrum in Groningen zal verblijven. De lengte van deze verblijfsperiodes is afhankelijk van hoe je reageert op het onderzoeksmiddel. 

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 type 2 diabetes and weight control by lowering blood sugar levels. People with type 2 diabetes have too much sugar in their blood and need treatment to control their sugar levels. The study 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 medications that act this way are already approved and being used to treat people living with diabetes and for weight control. The study compound can be administered more easily than those medications, because those medications are administered with an injection under the skin while the study compound can be given by mouth.

In this study we will investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body. In addition, we will look at the substances in the blood that are produced when the study compound is broken down by the body (known as breakdown products) and we will ask you to assess the taste of the study compound in tablet and capsule form. Furthermore, we will also investigate tablets that contain different particles sizes. We will also investigate how safe the study compound is and how well it is tolerated when it is used by healthy people.

The compound has already been tested in healthy individuals and patients with type 2 diabetes. In these clinical trials, the following side-effects were observed most often: nausea, vomiting and diarrhea. In general, these side effects were not considered severe. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. Once everything is clear to you, you can decide to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.

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 23.0 and at most 32.0 kg/m2. The BMI shows the relationship between body weight in kilograms and height in meters.
  • Both non-smokers and light smokers or occasional smokers (max. 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.

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 from the previous study).
  • 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 an intra-uterine device containing hormones) in combination with a condom. Please note: hormonal contraception taken by mouth (for example the contraceptive pill) is not allowed in this trial.
    • 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 only sexually active with a partner of the same sex;
    • You are not sexually active according to your lifestyle.
  • As a male no contraception measures are needed.

What is the compensation for this research?

Compensation

You will receive a gross compensation of at least € 9274 and at most € 12842 for participation in this trial if the third period does take place. If the third period does not take place, you will receive a gross compensation of at least € 7936 and at most € 11504.

Travel expenses will be reimbursed based on the distance traveled (€ 0.23 per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (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 3 periods in which you will stay in the research facility in Groningen for a minimum of 17 days (16 nights) and a maximum of 25 days (24 nights) during the first two periods. The duration of these periods of stay is dependent on how you respond to the study compound. After the second period it will be decided whether the third period will continue or the study will stop. If the third does continue, you will stay in the research facility in Groningen for 6 days (5 nights). The follow-up visit will take place 12 to 16 days after the last departure from the research facility.

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

Most frequently asked questions

If you are participating in a trial for which you have to stay at the research center for longer than ten days, it is sometimes possible to have visitors (in consultation).

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.

The amount of money you receive for your participation in a clinical trial is determined by the duration of the trial. The longer the trial takes, the higher the compensation. But there are also other factors that determine the amount of the compensation awarded, such as special medical procedures.

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.

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