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REIMAGINE 1 Clinical Study Webpage!

Here you will find information about our research project and how you can contribute, if you are eligible.

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REIMAGINE 1 is a clinical study in people living with Type 2 Diabetes

  

  

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About the study

Type 2 diabetes is a condition affecting the body’s ability to control blood sugar levels.

After a meal, blood sugar levels are restored by a process controlled by insulin, which enables the sugar from the meal to enter the cells in the body. In type 2 diabetes, the body does not produce or use insulin well and cannot keep blood sugar at normal levels. Over time, that can cause serious health problems, such as heart disease, vision loss, and kidney disease. There is not a cure yet for diabetes, but losing weight, eating healthy food, taking medications and being active can help.1

One group of people who have a high risk of developing type 2 diabetes are people living with overweight or obesity. Overweight and obesity is when your body stores too much fat. Treatment of overweight and obesity often includes lifestyle changes such as a different diet and more physical activity, as well as taking medications.2

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Why we are doing this study

We are doing this study to look at how well our new investigational combination study medicine is at controlling blood sugar and help loose weight in people with type 2 diabetes. The researchers will compare the effect of the new investigational combination study medicine to a “dummy medicine” without any active ingredient. Additionally, the researchers will also look at how safe and well tolerated the new investigational combination study medicine is. They will do this in a group of people living with type 2 diabetes for whom diet and physical activity alone are not enough to control their blood sugar.

Learn about our combination new investigational combination study medicine

CagriSema, the new medicine being tested in this study, is a combination of two individual components: cagrilintide and semaglutide.

Semaglutide: the approved individual component

The approved individual component is already approved for type 2 diabetes and weight management by the European Medicines Agency and the US Food and Drug Administration. It is similar to a hormone made in your body after eating a meal, called glucagon-like peptide-1 (GLP-1). It affects both your appetite and your body’s ability to regulate its blood sugar levels.

Like all medicines, the study medicines may have side effects. If you want to see if you can take part in this study, please find more information, and fill in the questionnaire in the bottom of the page. Depending on your answers you will be contacted within 48 hours for some additional information. If you fulfil the study criteria, you will be invited to an information meeting at a research site / hospital, where you will also get information about possible side effects of the study medication.

You can read more about other general questions related to participation in a clinical study on our FAQ page.

Cagrilintide: the individual component under development

The individual component under development is similar to a hormone made in the pancreas together with insulin, called amylin. Amylin is a hormone that is produced when you eat. It reduces the feeling of hunger before a meal and improves both the blood sugar levels and the feeling of fullness after a meal.

Like all medicines, the study medicines may have side effects. If you want to see if you can take part in this study, please find more information, and fill in the questionnaire in the bottom of the page. Depending on your answers you will be contacted within 48 hours for some additional information. If you fulfil the study criteria, you will be invited to an information meeting at a research site / hospital, where you will also get information about possible side effects of the study medication.

You can read more about other general questions related to participation in a clinical study on our FAQ page.

A “dummy” medicine or placebo

A “dummy” medicine or placebo looks like the new investigational combination study medicine but has no active ingredient. The dummy medicine is in the study to understand the real effect of a new treatment – both benefits and possible side effects.

Like all medicines, the new investigational combination study medicine may have side effects. If you want to see if you can take part in this study, please find more information, and fill in the questionnaire in the bottom of the page. Depending on your answers you will be contacted within 48 hours for some additional information. If you fulfil the study criteria, you will be invited to an information meeting at a research site / hospital, where you will also get information about possible side effects of the study medication.

You can read more about other general questions related to participation in a clinical study on our FAQ page.

  

Study Details

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In this study, the participants will either get the new investigational combination study medicine in one of two doses (1.0 mg/1.0 mg or 2.4 mg/ 2.4 mg) or “dummy” medicine. Which treatment the participants get is decided by chance. The treatment is given as an injection once a week throughout the treatment period. The new investigational combination study medicine is injected under the skin with a thin needle, in the thigh, stomach, or upper arm. The injection comes in the form of a pre-filled pen device.

Deciding if you want
to take part in the study

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Time Commitment

The total time you will be in this study is about 1 year.

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Responsibilities

​​​You will be invited to a series of hospital or office/clinic visits associated with the study and a series of phone calls during which a competent medical staff will guide you through the necessary study assessments and explain the procedures. 

If you want to see if you can take part in this study, please fill in the questionnaire on this page, and depending on your answers you will be contacted within 48 hours for some additional information.

Please note: completing the questionnaire does not guarantee participation in the study.

You are welcome to stop your participation at any time

You can decide no longer to take part in the study at any time – you do not have to give a reason

  • Your future medical care will not be affected if you stop taking part.
  • Your existing relationships with the hospital staff will not be impacted and you will continue being personally treated in the same way
  • If you decide to no longer participate in the study, treatment with the study medicine will be stopped immediately.
  • If you decide to stop taking part during the study, information about you that has already been collected can still be used for research. This is required by the health authorities to make sure that the results for the entire study can still be used.

PLEASE NOTE: You cannot take part in this study if you are already taking part in another study that is testing a medicine or treatment. You must also not join other studies that are testing a medicine or treatment if you decide to take part in this study. This is to protect your safety and the outcome of this study.

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How will you make a difference

Our new investigational combination study medicine may help people to gain better control of their blood sugar levels than diet and physical activity alone.

Additionally, the new investigational combination study medicine may help people to lose more weight than diet and physical activity alone.

By participating, you can help researchers to look at this in this study.

Also, the information we collect from you can help us better understand:

  • Type 2 diabetes and overweight or related conditions
  • How the new investigational combination study medicine works in the body
  • How to improve the treatment of people with type 2 diabetes

Join this study

If you are interested in this study or would potentially like to participate, please answer a couple of questions below and you will be contacted within 48 hours.

Please read carefully and answer the below questions for the study. 

*Are you aged 18 years or above?
*Have you had type 2 diabetes mellitus diagnosis for more than 30 days (1 month)?
*Have you taken any diabetes medication within 90 days before answering this questionnaire?
*Have you ever, or do you plan to have obesity treatment with surgery or a weight loss device?
*Have you ever used any diabetes medication as injection? If you have taken insulin for a short period (max 14 days) or insulin because you were pregnant (and had gestational diabetes), you do not have to mention it.

The information you submit, including your Personal Identifiable Information (your contact details), will be processed within the European Union by our Contact Center. Only representatives from our Contact Center can access and view your information. Please visit our Privacy Notice to learn more.

Next

Please provide your contact information in the form below. All fields marked with an (*) are required for the pre-screening form to be valid for the study.

*Are you male or female?
Is this a mobile device?
May a study team member contact you via SMS text message? (Message and data rates may apply)
Can the study team leave you a voicemail?
How did you hear about the study?

The information you submit, including your Personal Identifiable Information (your contact details), will be processed within the European Union by our Contact Center. Only representatives from our Contact Center can access and view your information. Please visit our Privacy Notice to learn more.

Do you agree to have a member of our Contact Center contact you to discuss the study in more detail and refer you to a study site if appropriate?

Send now
prescreener

Thank you for taking the time to answer this short questionnaire.

At this point, the answers we have received do not match the inclusion criteria of this study. None of your data has been passed through to us at this point. If you are interested, please navigate to the program page of the REIMAGINE studies to see, if there are other studies that run in your country.

Go to REIMAGINE trials
thankyou

Thank you for taking the time to complete this questionnaire.

We have received your details, and our team will review your responses. We appreciate your interest in our research and will be in touch with you soon to discuss your eligibility and provide further information about the study.

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Oops! Something went wrong

Apologies for the error encountered when submitting your data. No information has been passed on to us at this point and we will not be able to contact you. Please try again in a few hours. Thank you for your patience.

Please note: 

  • Completing the questionnaire does not guarantee participation in the study.
  • Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Women who can become pregnant must use highly effective contraception and will need to take pregnancy tests throughout the study.

  

References
  1. World Health Organization. Diabetes. Fact sheet [Internet]. World Health Organization; 2021 Nov [cited 2023 Apr 4]. Available from: https://www.who.int/news-room/fact-sheets/detail/diabetes
  2. World Health Organization. Obesity and overweight. Fact sheet [Internet]. World Health Organization; 2021 Aug [cited 2023 Apr 4]. Available from: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight

    

This site contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of a healthcare professional and should not be construed as providing advice or making a recommendation. The information on this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific product is correct for a particular patient. If you have questions regarding any information contained on this site you should consult a physician.

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