Approximately 50% of all women with a history of gestational diabetes will develop type 2 diabetes within 10 years after the index pregnancy. Women who already have prediabetes within 6 months after the delivery have a particularly high risk, as about 50% will develop type 2 diabetes within 5 years of the delivery. Hence, all women with a recent history of gestational diabetes are advised to maintain a healthy lifestyle after pregnancy. It is recommended to exercise enough, eat healthy and, if overweight, to also achieve at least 5% weight loss. However, it is often difficult to maintain this healthy lifestyle in the long-term, especially for young mothers with little time.

The purpose of the SERENA study is to determine whether the drug semaglutide (brand name Ozempic®) can reduce the risk of developing diabetes in women with elevated sugar levels (prediabetes) following a recent pregnancy with gestational diabetes. Semaglutide is a drug already commonly used in the normal routine to treat type 2 diabetes. It has been shown in individuals with type 2 diabetes that treatment with semaglutide can lower sugar levels, is often associated with weight loss and a lower risk of cardiovascular disease. With this study, we want to determine whether treatment with semaglutide can also have these beneficial effects in women with prediabetes after a recent pregnancy with gestational diabetes.

Who can participate?

Women who:

• Are 18 years of age or older,
• have had recent gestational diabetes and prediabetes within 1 year after the delivery
• have no desire for a new pregnancy within 1 year after starting with the study
• are not breastfeeding more than 22 months

To identify elevated sugar levels in a timely manner, a comprehensive fasting sugar test (OGTT) is done in women who have had gestational diabetes in the normal routine between 6 weeks – 12 months after delivery. If this test shows elevated sugar levels (prediabetes), you will be invited to participate in this study. A computer system will randomly decide whether you will be assigned to the group treated with semaglutide or with the inactive product (placebo). Neither the researchers, the treating physician nor the participant, will know whether the participant receives semaglutide or placebo. Both semaglutide and placebo will be administered by a subcutaneous injection once a week (in the abdomen, thigh -or arm). The participant will be taught to self-administer the injection.

Regardless of which group the participant is assigned to:

• Every 6 months fasting sugar levels will be measured and annually a fasting sugar test (OGTT)  will be performed, lifestyle education will be provided and at each visit together with a physical examination (height, weight, abdominal girth, blood pressure and body composition) and you will be asked to complete several questionnaires (such as on  nutrition, physical activity, depression, anxiety and motivation).
• Treatment will last up to 3 years.
• 3 months after the treatment has ended, you will receive a final fasting sugar test (OGTT) with blood sampling,

The eligibility to continue treatment with semaglutide after the end of the study will depend on whether or not the drug is reimbursed by the Belgian health insurance system.