All studies
Active not recruitingPHASE3INTERVENTIONAL

Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

This study is looking into a new medication called retatrutide and comparing it to an existing one called semaglutide. Both are for adults living with Type 2 Diabetes. The main aim is to see how well retatrutide helps control blood sugar levels when current treatments (like metformin, sometimes with another drug called an SGLT2 inhibitor) aren't quite enough. Researchers also want to make sure retatrutide is safe to use. By comparing these two medicines, doctors hope to find better ways to help people manage their Type 2 Diabetes, leading to improved health and fewer complications. The study will involve regular check-ups over about two years.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
1,250
Start
21 Feb 2024
Estimated completion
01 Jan 2027

What is this study about?

This study is called TRANSCEND-T2D-2 and it's all about helping people with Type 2 Diabetes. If you have Type 2 Diabetes, it means your body doesn't use insulin properly, or it doesn't make enough, which leads to high blood sugar levels. Over time, high blood sugar can cause health problems. Many people manage their diabetes with medicines like metformin, sometimes combined with another type of drug called an SGLT2 inhibitor.

The purpose of this research is to test a new medicine called retatrutide. We want to see how effective it is at lowering blood sugar levels compared to a medicine that's already in use, called semaglutide. We also want to understand if retatrutide is safe and if it causes any unwanted side effects when used by people whose current treatment isn't fully controlling their blood sugar.

By taking part, you would be helping doctors learn more about these medicines. This information could lead to better treatment options for people with Type 2 Diabetes in the future, ultimately improving their health and quality of life. This is a "Phase 3" study, which means the new medicine has already gone through earlier tests and is now being looked at in a larger group of people.

Key takeaways

  • Compares retatrutide with semaglutide for Type 2 Diabetes.
  • For adults with blood sugar not fully controlled by current treatment.
  • Aims to check both effectiveness and safety of the medicines.
  • Involves regular clinic visits over about 26 months.
  • Participation could help advance diabetes treatments.

Who may be eligible?

To join this study, you need to be an adult (18 or older) with Type 2 Diabetes. Your current diabetes treatment should include metformin (at least 1500mg daily), and you might also be taking another medicine called an SGLT2 inhibitor. Crucially, your blood sugar levels (measured by a test called HbA1c) should be between 7.0% and 10.5%, meaning your diabetes isn't fully controlled by your current medicines. You also need to have a Body Mass Index (BMI) of 25 or higher and your weight should have been stable for at least three months.

However, there are reasons why you might not be able to join. For example, if you have Type 1 Diabetes, or if you've had severe low blood sugar or certain serious diabetes problems in the last six months. Other reasons include having severe kidney or heart problems, a history of certain cancers, or if you've had surgery for weight loss. Also, if you've recently taken medicines to lose weight, you might not be able to participate. The study team will carefully check all these details with you.

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.

  1. Are you 18 years old or older?
  2. Do you have Type 2 Diabetes?
  3. Are you currently taking metformin and possibly an SGLT2 inhibitor for your diabetes?
  4. Is your HbA1c (blood sugar level) between 7.0% and 10.5%?
  5. Do you have a Body Mass Index (BMI) of 25 or more?
  6. Have you been on a stable weight for the last 3 months?
Answer every question to see your result.

What does participation involve?

If you join this study, it will involve regular visits to the clinic over roughly two years, which is about 26 months. You might have up to 24 appointments in total. During these visits, doctors and nurses will check your health, take blood samples, and ask about your general well-being. You would be given one of the two study medicines, either retatrutide or semaglutide, to help manage your blood sugar. The medical team will closely monitor you to see how the medicine is working and if you have any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical monitoring and potentially from a new treatment that could improve your blood sugar control. However, new medicines can have unknown side effects, and even established medicines have known ones. You might experience side effects from the study medication, or the medication might not work for you. There will be frequent visits which require your time. It's important to remember that you can stop participating in the study at any time without needing to give a reason, and this will not affect your usual medical care.

Locations (77)

  • University of Alabama - Department of Nutrition Sciences
    Verified postcode
    Birmingham, United States
  • Neighborhood Healthcare Institute of Health
    Verified postcode
    Escondido, United States
  • Long Beach Research Institute
    Verified postcode
    Long Beach, United States
  • Valley Clinical Trials, Inc.
    Verified postcode
    Northridge, United States
  • Rancho Cucamonga Clinical Research
    Verified postcode
    Rancho Cucamonga, United States
  • University of Colorado Anschutz Medical Campus
    Verified postcode
    Aurora, United States
  • Arrow Clinical Trials
    Verified postcode
    Daytona Beach, United States
  • New Age Medical Research Corporation
    Verified postcode
    Miami, United States
  • South Broward Research
    Verified postcode
    Miramar, United States
  • Clinical Research of Central Florida
    Verified postcode
    Winter Haven, United States
  • Herman Clinical Research
    Verified postcode
    Suwanee, United States
  • North Georgia Clinical Research
    Verified postcode
    Woodstock, United States

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 is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It helps doctors understand how well your diabetes is controlled.

What are metformin and SGLT2 inhibitors?

These are common medications used to help manage Type 2 Diabetes by lowering blood sugar levels in different ways.

What is a Phase 3 study?

A Phase 3 study means the new medicine has already been tested in smaller groups and is now being studied in a larger group of people to confirm its effectiveness and safety before it can be made widely available.

Will I know which medicine I'm getting?

In many studies like this, participants don't know whether they are receiving the new medicine or the comparison medicine. This helps ensure fair results.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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