All studies
Active not recruitingPHASE3INTERVENTIONAL

Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

This important study is testing a new medicine called Retatrutide. It's for people in the UK with Type 2 Diabetes who also have moderate or severe kidney problems. Participants are already taking insulin, sometimes with other common diabetes medicines like metformin or SGLT2 inhibitors, but still find their blood sugar hard to control. The study aims to see how well Retatrutide works to improve blood sugar compared to a placebo (a dummy medicine with no active drug), and to check for any side effects. This research could help find new ways to manage Type 2 Diabetes, especially for those with kidney issues.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
320
Start
15 Mar 2024
Estimated completion
01 Nov 2026

What is this study about?

This study, called TRANSCEND-T2D-3, is focused on finding new and better ways to manage Type 2 Diabetes, especially for people who also have kidney problems. We know that managing blood sugar levels is really important for people with Type 2 Diabetes to stay healthy and prevent complications. Some people find it hard to get their blood sugar under control even when using insulin and other common diabetes medicines.

The main goal of this study is to test a new medicine called Retatrutide. Researchers want to see if Retatrutide can help lower blood sugar levels more effectively than a placebo (a dummy treatment that looks just like the study medicine but contains no active drug). They also want to make sure Retatrutide is safe for people to use. By comparing the new medicine to a placebo, doctors can understand if any changes are truly due to Retatrutide.

Taking part in a study like this helps us learn more about new treatments. The information gathered will be used to understand if Retatrutide could be a helpful new option for people with Type 2 Diabetes and kidney problems in the future. This kind of research is carefully planned and supervised by medical experts to ensure the safety and well-being of all participants.

Key takeaways

  • This study is for adults with Type 2 Diabetes and kidney problems whose blood sugar is still hard to control on insulin.
  • It's testing a new medicine called Retatrutide against a dummy medicine (placebo).
  • Participation involves about 14 months and up to 22 visits.
  • Your health will be closely monitored by a specialist team.
  • You can stop participating at any time.
  • The findings could lead to new treatments for Type 2 Diabetes.

Who may be eligible?

This study is looking for adults aged 18 or over who have Type 2 Diabetes. You would need to have moderate or severe kidney problems and your most recent blood tests should show that your blood sugar (HbA1c) is still quite high, even though you are already taking insulin. You might also be taking metformin or an SGLT2 inhibitor.

There are also some things that would mean you couldn't join. For example, if you have Type 1 Diabetes, or a history of very severe low blood sugar. Also, if you've had certain heart problems recently, or have certain types of cancer or thyroid conditions, you wouldn't be able to take part. The study also cannot include you if you've recently had surgery for weight loss or other specific medical conditions.

The research team will carefully review all your health information to make sure the study is a good fit for you and that it's safe for you to participate.

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. Do you have moderate or severe kidney problems?
  4. Are you currently taking insulin for your diabetes?
  5. Is your blood sugar (HbA1c) still above 7.0-9.0% (53-91 mmol/mol)?
  6. Have you been on your current diabetes treatment for at least 3 months, and your weight has been stable?
Answer every question to see your result.

What does participation involve?

If you join this study, it will last for about 14 months. During this time, you would need to attend up to 22 visits at the study clinic. These visits will involve various checks and tests to monitor your health and how you respond to the study medicine. You will be given either the new medicine, Retatrutide, or a placebo (a dummy medicine), and neither you nor your study doctor will know which you are receiving until the end of the study. This helps to ensure the results are accurate. The research team will guide you through each step and explain everything clearly.

Potential risks and benefits

Taking part in this study could offer some benefits, such as contributing valuable information that might help other people with Type 2 Diabetes and kidney problems in the future. You will also receive regular monitoring of your health from a dedicated medical team. However, like all medicines, Retatrutide could have side effects, and the placebo might not improve your condition. The research team will explain all known risks and carefully monitor you throughout the study. You will always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (76)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Nephrology Consultants
    Verified postcode
    Huntsville, United States
  • Clinical Research Institute of Arizona (CRI) - Sun City West
    Verified postcode
    Sun City West, United States
  • Kidney & Hypertension Center - Apple Valley
    Verified postcode
    Apple Valley, United States
  • Hope Clinical Research, Inc.
    Verified postcode
    Canoga Park, United States
  • Neighborhood Healthcare Institute of Health
    Verified postcode
    Escondido, United States
  • EndoTrials Center for Clinical Research
    Verified postcode
    La Mesa, United States
  • UCLA South Bay Endocrinology
    Verified postcode
    Torrance, United States
  • Northeast Research Institute (NERI)
    Verified postcode
    Fleming Island, United States
  • Encore Medical Research - Weston
    Verified postcode
    Weston, United States
  • Orita Clinical Research
    Verified postcode
    Decatur, United States
  • CARE Institute
    Verified postcode
    Idaho Falls, United States
  • Cotton O'Neil Diabetes & Endocrinology
    Verified postcode
    Topeka, United States

Common questions

What is a placebo?

A placebo is a dummy medicine that looks exactly like the study medicine but contains no active drug. It helps doctors see if the new medicine really works better than no treatment.

How long will I be in the study?

The study will last for about 14 months from when you start.

Will I still take my regular diabetes medicines?

The study is designed for people who are already on insulin, and possibly metformin or SGLT2 inhibitors. The research team will discuss your current medications with you.

What is 'renal impairment'?

Renal impairment is another way of saying you have kidney problems or kidney disease.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your normal medical care.

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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