All studies
Active not recruitingPHASE3INTERVENTIONAL

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

This research study aims to understand the long-term impact of a medication called semaglutide on eye conditions caused by diabetes in people living with type 2 diabetes. Participants will be randomly assigned to receive either semaglutide or a placebo (a dummy medicine) through a weekly injection. This will be in addition to their regular diabetes treatments. Researchers want to see if semaglutide helps prevent diabetic eye disease from worsening over a five-year period. The study involves injecting the medicine into a skin fold in the stomach, thigh, or upper arm once a week using a special pen. The main goal is to compare how both groups' eyes are affected.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Novo Nordisk A/S
Enrolment target
1,500
Start
08 May 2019
Estimated completion
07 Nov 2027

What is this study about?

This research study is looking into problems with the eyes that can happen when someone has type 2 diabetes. These eye problems are called diabetic eye disease, and they can sometimes lead to serious vision issues. The study wants to find out if a medicine called semaglutide can help to slow down or prevent these eye problems from getting worse. This is really important because keeping our eyes healthy is key to a good quality of life, and finding new ways to protect vision for people with diabetes is a big step forward.

To do this, researchers will compare semaglutide with a 'placebo', which is a dummy medicine that looks just like semaglutide but doesn't contain any active drug. This helps them understand whether any changes observed are truly due to the active medicine or if they might have happened anyway. All participants will continue taking their usual diabetes medicines, and the study medicine (semaglutide or placebo) will be an additional treatment.

The study is designed to watch participants for a long time – five years. This long period allows researchers to see the long-term effects of the medicine on eye health. By carefully studying both groups, they hope to get a clear answer about whether semaglutide can make a real difference for people with type 2 diabetes and their eyes.

Key takeaways

  • Study examines semaglutide's impact on diabetic eye disease.
  • For people with type 2 diabetes and specific eye conditions.
  • Involves weekly injections of either semaglutide or a dummy medicine.
  • Study lasts for five years, with regular eye and health checks.
  • Aims to find new ways to protect vision in diabetes.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with type 2 diabetes. Your diabetes blood sugar levels (measured by an HbA1c test) should be within a specific range, between 7.0% and 10.0%.

Crucially, your eyes will be checked very carefully. Both your eyes need to show certain signs of diabetic eye disease, but not be too severe yet. You cannot have had any eye treatments for your diabetes in the last six months, and you shouldn't need any in the next few months after starting the study. Your vision also needs to be at a certain level. There are also some specific eye conditions or past treatments that would mean you can't join.

There are also some important health conditions that would prevent you from taking part. For example, if you've recently had a heart attack or stroke, or if you have severe kidney problems or certain types of cancer. Women who are pregnant, breastfeeding, or planning to become pregnant cannot 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. Is your HbA1c (blood sugar level) between 7.0-10.0%?
  4. Have you *not* had eye treatment for diabetes in the last 6 months?
  5. Are you *not* pregnant, breastfeeding, or planning to be?
  6. Do you *not* have recent heart attack, stroke, or severe kidney problems?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be taking medication for five years. You'll be randomly assigned to receive either semaglutide or a dummy medicine. Whichever you receive, you'll inject it once a week using a pen-injector. This injection goes into a skin fold in your stomach, thigh, or upper arm. You will be taught exactly how to do this safely.

Throughout the five years, you will have regular hospital or clinic visits. These visits will involve various tests and checks to monitor your health, particularly your diabetes and eye health. Eye examinations will be a key part of these visits, including special photographs of your eyes. The research team will track any changes in your eye condition, as well as your general health and how well you're tolerating the study medicine. You will also continue with your usual diabetes medications and care from your own doctor.

Potential risks and benefits

Participating in research studies can offer the potential benefit of accessing new medicines that aren't widely available yet, which might help your eye health. However, there are also potential risks, such as side effects from the study medicine or discomfort from injections or tests. It's important to remember that you might receive the placebo (dummy medicine) and not the active drug. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (229)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Synexus Rsch /Cnt Phnx Med C
    Verified postcode
    Phoenix, United States
  • Del Sol Research Management, LLC
    Verified postcode
    Tucson, United States
  • South Arizona VA Healthcare System
    Verified postcode
    Tucson, United States
  • Synexus Cln Rsrch Inc - Orange Gro FP
    Verified postcode
    Tucson, United States
  • Southern California Res Ctr
    Verified postcode
    Coronado, United States
  • FDRC
    Verified postcode
    Costa Mesa, United States
  • Advanced Investigative Medicine, Inc.
    Verified postcode
    Hawthorne, United States
  • Diabetes/Lipid Mgmt & Res Ctr
    Verified postcode
    Huntington Beach, United States
  • Scripps Whittier Diabetes Inst
    Verified postcode
    La Jolla, United States
  • Torrance Clin Res Inst, Inc.
    Verified postcode
    Lomita, United States
  • Angel City Research, Inc.
    Verified postcode
    Los Angeles, United States
  • Downtown LA Res Ctr. Inc.
    Verified postcode
    Los Angeles, United States

Common questions

What is semaglutide?

Semaglutide is a medicine that helps manage blood sugar levels in people with type 2 diabetes. This study will also look at its effect on eye health.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real thing but contains no active drug. It helps researchers compare the effects of the active medicine.

Will I know if I'm getting semaglutide or the placebo?

No, you won't know which you are receiving. This is to ensure the study results are fair and unbiased.

How long will the study last?

The study itself will last for five years, during which you will be taking the study medicine and attending regular check-ups.

Will this study affect my current diabetes treatment?

No, you will continue with your current diabetes medications. The study medicine will be added to your existing treatment.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.