Study of Semaglutide for Treating Prediabetes in Women with Previous Gestational Diabetes

1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
AZ Turnhout Turnhout Belgium
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Jan Yperman Ziekenhuis Ieper Belgium
Centre hospitalier universitaire de Liege Liege Belgium
Vrije Universiteit Brussel Jette Belgium
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Vitaz Sint-Niklaas Belgium
Centre Hospitalier de Mouscron Mouscron Belgium
Hao Zxgogdkyibxmbslrc Awmqhddov Antwerp Belgium
Uufrtzkekt Oc Akuqidi Edegem Belgium
Owfneniewsdbyiledcqrkqmewu Aalst Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
02.05.2023

Trial locations

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.

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 ID:
2022-502082-22-00
Protocol code:
S66967
NCT ID:
NCT05569772
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • Study of dapagliflozin and semaglutide to reverse prediabetes to normal blood sugar levels in patients with coronary artery disease

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark
  • Evaluation of controlled-ileal-release nicotinic acid tablets compared to placebo for treating people with prediabetes

    Recruiting

    Germany