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Study of Semaglutide for Treating Prediabetes in Women with Previous Gestational 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 studying the treatment of glucose intolerance in women who have previously experienced gestational diabetes, a condition where blood sugar levels become high during pregnancy. The study will use a medication called semaglutide, which is administered as a solution for injection using a pre-filled pen. Semaglutide is also known by its code name, NNC0113-0217. Participants in the study will receive either semaglutide or a placebo, which is an inactive substance that looks like the medication but does not contain the active ingredient.

The purpose of the study is to compare the development of type 2 diabetes over a period of 160 weeks between those receiving semaglutide and those receiving the placebo. The study will monitor participants' blood sugar levels using tests such as fasting glycaemia, oral glucose tolerance test (OGTT), and HbA1c, which is a measure of average blood sugar levels over the past three months. These tests will help determine if semaglutide can effectively prevent the progression to type 2 diabetes in women with a history of gestational diabetes and current glucose intolerance.

Throughout the study, participants will be regularly assessed to track their health and any changes in their condition. The study will also look at secondary outcomes, such as the need for additional diabetes treatment, changes in body weight, and improvements in blood sugar control. The trial aims to provide valuable insights into the potential benefits of semaglutide for preventing type 2 diabetes in this specific group of women.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, a healthcare professional will explain the study details and answer any questions.

    Participants will receive a pre-filled pen containing either Ozempic (semaglutide) or a placebo. The pen is used for subcutaneous injection, which means the medication is injected under the skin.

  2. Step 2

    Medication administration

    Participants will administer the injection once a week. The dosage is 1 mg of Ozempic or placebo, depending on the group assignment.

    The duration of the medication administration is up to 160 weeks.

  3. Step 3

    Regular follow-up visits

    Regular follow-up visits will be scheduled throughout the study period. These visits are important for monitoring health and progress.

    During these visits, various health parameters will be assessed, including blood sugar levels and body measurements.

  4. Step 4

    End of treatment

    The treatment phase concludes at 160 weeks. Participants will stop taking the medication at this point.

    A final assessment will be conducted to evaluate the development of type 2 diabetes and other health outcomes.

  5. Step 5

    Post-treatment follow-up

    After stopping the medication, a follow-up period of 3 to 6 months will occur. This is to monitor any changes in health status after the treatment ends.

    Participants will be assessed for any need for additional diabetes therapy and other health indicators.

Who can join the trial?

6 criteria

  • The participant must provide voluntary written informed consent. This means they agree to join the study after being fully informed about it.
  • The participant must use highly effective birth control methods. These are methods that have a very low chance of failing, such as implants, injections, birth control pills, certain IUDs (intrauterine devices), or having a partner who has had a vasectomy. Alternatively, the participant can choose to completely avoid heterosexual intercourse during the study.
  • The participant must have a history of gestational diabetes mellitus (GDM). This is a type of diabetes that occurs during pregnancy. The diagnosis should have been made using specific criteria between 24-32 weeks of pregnancy.
  • The participant must have glucose intolerance 6-24 weeks after giving birth. This means their blood sugar levels are higher than normal but not high enough to be classified as diabetes. The test for this should be done after they have stopped breastfeeding.
  • The participant must be able to understand and speak Dutch, French, or English.
  • The participant must be female.

Who cannot join the trial?

3 criteria

  • Patients who do not have **prediabetes** cannot participate.
  • Only **female** patients can participate; male patients are excluded.
  • Patients who are part of a **vulnerable population** are not eligible. This means people who might need special protection or care.
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Investigated drugs

Semaglutide is a medication used in this clinical trial to help manage blood sugar levels in women who have had gestational diabetes, which is a type of diabetes that can occur during pregnancy. The main goal of using semaglutide in this study is to see if it can prevent or delay the development of type 2 diabetes in these women. Semaglutide works by helping the body produce more insulin when blood sugar levels are high, and it also helps to reduce the amount of sugar released by the liver. This can help keep blood sugar levels more stable over time.

What is already known about the treatment

Semaglutide – Semaglutide is administered as an injection under the skin, typically once a week. It is currently being studied for its effectiveness in preventing type 2 diabetes in women who have had gestational diabetes, a condition where blood sugar levels are high during pregnancy. The medication works by mimicking a natural hormone in the body that helps regulate blood sugar levels, making it easier for the body to manage glucose. Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists, which are used to improve blood sugar control in people with type 2 diabetes.

Investigated diseases

Prediabetes – Prediabetes is a condition where blood sugar levels are higher than normal but not high enough to be classified as type 2 diabetes. It often develops gradually and may not present noticeable symptoms. Over time, if lifestyle changes are not made, prediabetes can progress to type 2 diabetes. The condition is characterized by impaired fasting glucose or impaired glucose tolerance. It is often identified through blood tests measuring fasting glucose levels, oral glucose tolerance, or hemoglobin A1c. Prediabetes is a critical stage for intervention to prevent the onset of type 2 diabetes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502082-22-00Protocol codeS66967Estimated enrolment252 patientsSponsorUZ Leuven

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