Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study comparing exposure of semaglutide and dapagliflozin dosed orally as mono-components versus in a fixed-dose combination

This research is a Phase I study focusing on adults with type 2 diabetes. It is designed to understand how the body handles two important diabetes medications: semaglutide and dapagliflozin. The study is comparing what happens when these drugs are taken individually versus when they are given together in one combined tablet. Researchers are particularly interested in how much of the medicine gets into the bloodstream and how long it stays there. The aim is to see if combining these medicines into a single dose affects how they work in the body, which could help in developing easier and more effective treatments for type 2 diabetes in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Novo Nordisk A/S

Enrolment target

138

Start

02 Jun 2022

Diabetes Mellitus Type 2

What is this study about?

This study is a type of research called a 'human pharmacology' or 'Phase I' study. This is usually one of the first steps when new medicines or new ways of giving medicines are being tested in people. The main purpose here is to understand how your body takes in, uses, and gets rid of two specific medicines used to treat type 2 diabetes: semaglutide and dapagliflozin. These types of studies are really important for making sure medicines are processed by the body in a safe and effective way.

In this research, scientists want to compare what happens when you take semaglutide and dapagliflozin as separate tablets versus when they are put together into one tablet. They will be carefully measuring the amount of each medicine in your blood over time. This helps them understand if combining them changes how much medicine gets into your system and how long it stays there, compared to taking them individually.

Understanding these differences is key. If the combined tablet works just as well as the separate ones, it could mean that people with type 2 diabetes might only need to take one tablet instead of two, which could make managing their condition much simpler. This study doesn't look at whether the combined tablet treats diabetes better, but rather at these important first steps of how the body handles the medicine.

Key takeaways

Tests how the body handles two diabetes medications (semaglutide and dapagliflozin).
Compares taking medicines separately versus in one combined tablet.
Aims to understand how much medicine enters the bloodstream and for how long.
A Phase I study – an early step in medicine development.
Could lead to simpler treatment options for type 2 diabetes.
Involves regular clinic visits and blood tests.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

Because this is a very early-stage study, there will likely be other health checks to make sure it's safe for you to participate. These usually involve making sure you are generally healthy, apart from your type 2 diabetes, and that any other health conditions you have are well managed.

The research team will go through all the specific requirements with you in detail. It’s important to remember that they need to ensure the study is safe for everyone involved, so they will ask specific questions about your health and medical history before you can join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have type 2 diabetes?
Are you generally in good health, aside from your diabetes?
Are you able to attend several clinic appointments?
Are you happy to take study medication and have regular blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given different versions of the medicines to take at different times. These will include semaglutide by itself, dapagliflozin (known as Forxiga) by itself, and then different combinations of both medicines in a single tablet. All study medications are taken by mouth.

You will need to attend several appointments at the study clinic. During these visits, the research team will take blood samples regularly to measure the levels of the medicines in your body. They will also keep a close eye on your health and check for any side effects. Each visit might involve spending several hours at the clinic, and the study will likely last for a number of weeks or months in total, with periods of taking the medication and periods without.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. A potential benefit of this study is contributing to our understanding of how these diabetes medications work, which could help improve treatments for many people in the future. You will also receive careful medical monitoring throughout the study. Potential risks could include side effects from the medications, which will be carefully explained to you by the study team. There might also be discomfort from blood tests or time commitments for study visits. It is important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is the main goal of this study?

The main goal is to see how your body handles two specific diabetes medicines when they are given separately versus combined into one pill.

What kind of medicines are being tested?

The medicines are called semaglutide and dapagliflozin (also known as Forxiga), both used for type 2 diabetes.

Will I have to attend many appointments?

Yes, you will need to attend several clinic visits for blood tests and health checks over the course of the study.

Will this study cure my diabetes?

No, this study is not designed to cure diabetes. It's a very early-stage study focused on how medicines are processed by the body.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without having to give a reason, and it won't affect your medical care.