Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

I8F-MC-GPGN: The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)

This research study, called SURPASS-CVOT, is designed for people who have type 2 diabetes. Its main goal is to find out if a new medicine called tirzepatide is better than an existing medicine, dulaglutide, at protecting your heart and blood vessels. Researchers want to see if tirzepatide can reduce the chance of serious heart-related events like heart attacks, strokes, or even death from heart problems. This is a large-scale study, meaning many people will take part, which helps doctors understand the medicines' effects clearly. The results will help doctors decide the best treatments to keep people with type 2 diabetes healthy and reduce their risk of heart complications.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Eli Lilly & Co.

Enrolment target

4,301

Start

15 Nov 2023

Type 2 Diabetes Mellitus

What is this study about?

This study is for people living with type 2 diabetes. Often, diabetes can increase your risk of developing heart and blood vessel problems, such as a heart attack or a stroke. Doctors are always looking for medicines that not only help control your blood sugar but also offer extra protection for your heart.

In this study, researchers want to compare two medicines: tirzepatide and dulaglutide. Both are used to treat type 2 diabetes. Dulaglutide is already a well-known medicine, and we know it can help protect the heart. Tirzepatide is a newer medicine, and early results suggest it might also be very good for your heart, perhaps even better than dulaglutide. This study aims to confirm these findings.

By comparing these two treatments directly, doctors hope to get a clear answer about which one is more effective at preventing serious heart-related events. The results of this study will be very important for guiding doctors on the best ways to treat people with type 2 diabetes, helping them live longer, healthier lives and reduce their risk of cardiovascular complications.

Key takeaways

Compares two diabetes medicines: tirzepatide and dulaglutide.
Aims to see which is better at protecting your heart.
Looks at serious events like heart attacks and strokes.
For adults aged 18 and over with type 2 diabetes.
Results will help doctors choose better treatments.

Who may be eligible?

To join this study, you must be 18 years old or older. The study is open to both men and women.

Crucially, you must have been diagnosed with type 2 diabetes. The study will also look for people who have certain heart health factors that might put them at a higher risk of heart problems.

There will be other detailed health checks to make sure the study is right and safe for you. These will likely include reviewing your medical history and current health status. It's important to discuss all your health conditions and any medicines you are taking with the study team.

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?
Have you been diagnosed with type 2 diabetes?
Are you willing to take an injectable medicine for diabetes?
Are you able to attend regular clinic visits for monitoring?
Do you have a history or risk factors for heart problems?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned to take either tirzepatide or dulaglutide. These will be given as injections. You will have regular visits to a clinic over several years for check-ups, blood tests, and to discuss how you are feeling. The study team will monitor your health closely, paying special attention to your blood sugar levels and heart health. You will be given detailed instructions on how to take your medication. The total duration of the study will be determined by how long it takes to gather enough information about the heart-related events, so it could last for several years. You'll receive support and advice from the study team throughout.

Potential risks and benefits

By taking part, you might benefit from closely monitored care and receive a medicine that could improve your heart health and diabetes control. You would also be contributing valuable information that could help many other people with type 2 diabetes in the future. However, there are potential risks, as with any medicine. These medicines can have side effects, which will be carefully explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

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

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Unverified
Slovakia
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Unverified
France
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Unverified
Hungary
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Unverified
Netherlands
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Unverified
Belgium
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Unverified
Czechia
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Unverified
Sweden
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Unverified
Spain
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Unverified
Romania
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Unverified
Austria
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Unverified
Italy
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Unverified
Germany

Common questions

What is 'Type 2 Diabetes'?

Type 2 diabetes is a condition where your body doesn't produce enough insulin or doesn't use insulin properly, leading to high blood sugar levels.

What are 'Major Adverse Cardiovascular Events'?

These are serious heart and blood vessel problems like heart attacks, strokes, or death from heart-related causes.

What do 'tirzepatide' and 'dulaglutide' do?

They are medicines for type 2 diabetes that help control blood sugar and may also protect your heart.

Will I know which medicine I'm getting?

Typically, in this type of study, neither you nor your doctor will know which specific medicine you are receiving to keep the results fair and unbiased.

How long will the study last?

This type of study can last for several years, as researchers need to follow participants over time to see the long-term effects on heart health.