Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes

This research is focused on adults in the UK who have type 2 diabetes. It's looking into a new treatment called Tirzepatide. If you're currently taking a weekly medicine called Dulaglutide, this study wants to see what happens when you switch to Tirzepatide. The main goal is to check how well Tirzepatide lowers blood sugar levels (measured by something called HbA1c) compared to staying on Dulaglutide. They'll also be looking at other important aspects like weight changes and your overall health and well-being. This study has already passed the main testing stages, so it’s now about seeing how these treatments work in everyday use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Eli Lilly Cork Limited

Enrolment target

145

Start

14 Feb 2023

Type 2 Diabetes

What is this study about?

This study is for adults living with type 2 diabetes. It's a 'Phase 4' trial, which means the medicines involved have already been approved and are being used, but doctors want to learn more about how they work in real-world settings. The main aim is to compare two weekly medications: Dulaglutide and Tirzepatide. Patients currently on Dulaglutide for their type 2 diabetes would either continue with it or switch to Tirzepatide.

The main thing researchers want to find out is whether switching to Tirzepatide helps to control blood sugar levels (something doctors measure as HbA1c) better than staying on Dulaglutide. Your HbA1c tells doctors what your average blood sugar has been over the past two to three months. They'll also be closely watching other important health measures that affect people with type 2 diabetes, such as weight, waist size, and overall body health (BMI).

Beyond blood sugar and weight, the study will also look at how these treatments might affect your general health and how diabetes impacts your everyday life. This includes things like feeling well and your ability to do physical activities. Understanding these broader effects is really important for finding the most helpful long-term treatments for type 2 diabetes.

Key takeaways

Compares two diabetes medicines: Dulaglutide and Tirzepatide.
Aims to improve blood sugar control (HbA1c) and possibly aid weight loss.
Only for adults with type 2 diabetes currently using weekly Dulaglutide.
Involves regular health checks and blood tests.
You will know which medicine you are receiving.

Who may be eligible?

This study is looking for adults aged 18 years and older. Both men and women are welcome to take part. The most important thing is that you have been diagnosed with type 2 diabetes.

Crucially, you must currently be taking a weekly medicine called Dulaglutide for your type 2 diabetes to be considered for this study. The researchers want to see what happens when people switch from Dulaglutide or continue taking it.

There might be other health conditions or medicines you are taking that mean you can't join the study, but the study team will discuss all of this with you in detail.

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 a diagnosis of type 2 diabetes?
Are you currently taking a weekly medicine called Dulaglutide?
Are you able to attend regular appointments for checks and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to either continue taking your current weekly Dulaglutide or switch to a new weekly medicine called Tirzepatide. This decision will be made like flipping a coin, so neither you nor the doctor can choose which group you are in. You will know which medicine you are taking.

You'll have several visits to the clinic where the study team will take blood tests to check your blood sugar (HbA1c) and other health markers. They'll also measure your weight, waistline, and ask you questions about your health and how you're feeling. These visits help the researchers understand how the medicines are affecting you.

The study will involve taking your assigned medication as instructed and attending all scheduled appointments. The total duration of your participation in the study, including all treatments and follow-up checks, will be explained fully by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. You might benefit from closer medical monitoring and access to a newer treatment for your diabetes. There's a chance your blood sugar control or weight could improve. However, like all medicines, Dulaglutide and Tirzepatide can have side effects. These will be fully explained by the study team before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Romania
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Unverified
Germany
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Unverified
Belgium
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Unverified
France

Common questions

What is the main purpose of this study?

The main purpose is to see how effectively a new medicine, Tirzepatide, helps adults with type 2 diabetes control their blood sugar compared to their current medicine, Dulaglutide, and if it also affects their weight and overall health.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months. It's an important measure for people with diabetes.

Will I know which medicine I'm taking?

Yes, in this study, both you and your doctor will know which medicine you are taking – either Dulaglutide or Tirzepatide.

What happens if I want to stop participating?

You can leave the study at any time, for any reason, and it will not affect your usual medical care or your relationship with your healthcare team.

Is this a new medicine that's never been used before?

No, both Dulaglutide and Tirzepatide are approved medicines. This study is mainly to learn more about how they work in real-world situations, especially when switching treatments for type 2 diabetes.