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Study on the Effects of Semaglutide on Diabetic Eye Disease in People with Type 2 Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding the long-term effects of the medication semaglutide on a condition called diabetic retinopathy in people with type 2 diabetes. Diabetic retinopathy is an eye disease that can occur in individuals with diabetes, potentially leading to vision problems. The study will compare the effects of semaglutide, which is administered as a solution for injection, to a placebo. The purpose of the study is to assess how semaglutide affects the development and progression of diabetic retinopathy when added to the usual care for type 2 diabetes.

Participants in the study will receive either semaglutide or a placebo through a pre-filled pen injector, which allows for easy administration under the skin. The study will take place over several years, during which participants will undergo regular eye examinations to monitor any changes in their condition. These assessments will help determine if semaglutide has a beneficial effect on preventing or slowing down the progression of diabetic retinopathy compared to the placebo.

The study aims to provide valuable insights into the safety and effectiveness of semaglutide for individuals with type 2 diabetes who are at risk of developing diabetic retinopathy. By participating in this research, it is hoped that new information will be gathered to improve the management and treatment of this eye condition in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), a diagnosis of type 2 diabetes, and specific HbA1c levels (7.0-10.0%).

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes evaluating visual acuity and other eye health indicators using standardized ophthalmic assessments.

  3. Step 3

    Treatment administration

    Participants receive either semaglutide or a placebo. The medication is administered as a subcutaneous injection using a pre-filled pen. The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Ongoing monitoring

    Regular monitoring occurs throughout the study to track the development and progression of diabetic retinopathy. This includes periodic eye examinations and assessments of visual acuity.

  5. Step 5

    Yearly evaluations

    Annual evaluations are conducted to assess changes in eye health and other health indicators. These evaluations include measuring visual acuity and checking for any progression in diabetic retinopathy.

  6. Step 6

    Final assessment

    At the end of the study period, a comprehensive assessment is performed to evaluate the long-term effects of the treatment on diabetic retinopathy. This includes a final eye examination and comparison with baseline measurements.

Who can join the trial?

3 criteria

  • Must be a male or female who is at least 18 years old at the time of signing the consent form.
  • Must have been diagnosed with type 2 diabetes mellitus, which is a condition where the body does not use insulin properly.
  • Must have an HbA1c level between 7.0% and 10.0%. HbA1c is a blood test that shows the average level of blood sugar over the past 2 to 3 months.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to the study medication or similar medications cannot participate.
  • Individuals with a current or past history of certain eye diseases, other than diabetic retinopathy, may be excluded.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is not well-managed, are not eligible.
  • People with severe kidney disease, which affects how well the kidneys work, cannot join the study.
  • Participants who have had a heart attack or stroke within the last 6 months are not allowed to participate.
  • Individuals with a history of certain types of cancer may be excluded from the study.
  • Pregnant or breastfeeding women cannot take part in the trial.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Individuals with a history of drug or alcohol abuse may be excluded from the study.
  • People with certain mental health conditions that might affect their ability to follow the study procedures cannot participate.
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Investigated drugs

Semaglutide is a medication used in this clinical trial to evaluate its long-term effects on diabetic retinopathy in individuals with type 2 diabetes. It is added to the standard care that patients are already receiving. The goal is to see if semaglutide can help prevent or slow down the progression of diabetic retinopathy, which is a complication of diabetes that affects the eyes.

What is already known about the treatment

Semaglutide – Semaglutide is administered as a subcutaneous injection, typically once a week. It is currently approved for use in managing type 2 diabetes and is being studied for its effects on diabetic retinopathy. The main therapeutic indication is to improve blood sugar control in adults with type 2 diabetes. At the molecular level, semaglutide works by mimicking the action of a natural hormone called GLP-1, which increases insulin secretion and decreases glucagon release, helping to lower blood sugar levels. It is classified as a GLP-1 receptor agonist.

Investigated diseases

Diabetic Retinopathy – Diabetic retinopathy is a complication of diabetes that affects the eyes. It occurs when high blood sugar levels cause damage to the blood vessels in the retina, the light-sensitive tissue at the back of the eye. In the early stages, there may be no symptoms, but as the condition progresses, it can lead to vision problems. Over time, the damaged blood vessels can leak fluid or bleed, leading to vision impairment. In advanced stages, new abnormal blood vessels can grow, which can further worsen vision. Regular eye examinations are crucial for individuals with diabetes to monitor and manage this condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506827-26-00Protocol codeNN9535-4352Estimated enrolment1 467 patientsSponsorNovo Nordisk A/S

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