Researchers are testing whether semaglutide, a weekly injection medication, can prevent type 2 diabetes in 252 women who had gestational diabetes during pregnancy and developed prediabetes afterward. According to Gram Research analysis, this Belgian randomized controlled trial will follow women for 3.5 years to compare diabetes development rates between those receiving semaglutide plus lifestyle counseling versus placebo plus lifestyle counseling. Results aren’t yet available since the study began recruiting in September 2023.
A major study is testing whether a diabetes medication called semaglutide can prevent type 2 diabetes in women who had gestational diabetes during pregnancy. According to Gram Research analysis, this Belgian trial will follow 252 women for three and a half years to see if weekly injections combined with lifestyle changes can stop prediabetes from turning into full diabetes. Women who develop diabetes during pregnancy face a much higher risk of developing type 2 diabetes later in life, so researchers are looking for effective ways to protect them during the critical postpartum period.
Key Statistics
A Belgian randomized controlled trial of 252 women is testing whether weekly semaglutide injections can prevent type 2 diabetes in women with postpartum prediabetes after gestational diabetes, with results expected in 2026-2027.
Women with a history of gestational diabetes are 7-10 times more likely to develop type 2 diabetes later in life, making prevention strategies during the postpartum period particularly important.
The SERENA study will track participants for 3.5 years with clinical assessments every 6 months, measuring not only diabetes development but also weight loss, insulin sensitivity, and cost-effectiveness of the treatment approach.
The Quick Take
- What they studied: Whether a weekly injection of semaglutide (a medication that helps control blood sugar) can prevent women with prediabetes after pregnancy from developing type 2 diabetes
- Who participated: 252 women in Belgium who had gestational diabetes during pregnancy and developed prediabetes after giving birth, divided equally into two groups receiving either semaglutide or placebo
- Key finding: This is a protocol paper describing a study that’s currently underway (started September 2023), so results aren’t available yet. The study will track whether semaglutide prevents diabetes development over 3.5 years
- What it means for you: If successful, this research could offer women who had pregnancy diabetes a new medical option to prevent type 2 diabetes, though lifestyle changes remain important. Results won’t be available for several more years
The Research Details
The SERENA study is a randomized controlled trial, which is considered the gold standard for testing whether a treatment actually works. Researchers randomly assigned 252 women into two equal groups: one receiving weekly semaglutide injections plus lifestyle counseling, and another receiving placebo injections plus the same lifestyle advice. By randomly assigning women, researchers ensure the groups are similar at the start, so any differences in outcomes are likely due to the medication rather than other factors.
The study takes place across 13 hospitals in Belgium and will last 3.5 years total. Women will visit the clinic every 6 months for blood tests, physical exams, and questionnaires about their health. The researchers stratified (organized) participants by body mass index to ensure both groups had similar proportions of women at different weights, which helps make the comparison fair.
Semaglutide is a medication that mimics a natural hormone in your body that helps control blood sugar levels. It’s already approved for treating type 2 diabetes and weight loss, but this study is testing whether it can prevent diabetes from developing in the first place in this high-risk group.
This research design is important because it will provide strong evidence about whether semaglutide actually prevents diabetes in this specific population. Women who had gestational diabetes are 7-10 times more likely to develop type 2 diabetes later, making them an ideal group to study for prevention. The randomized, double-blind design (where neither participants nor researchers know who got the real drug) prevents bias and ensures the results are trustworthy.
This is a high-quality study design published in a reputable journal (BMJ Open). The study was approved by Belgian health authorities and ethics committees before starting. The large sample size (252 women) and long follow-up period (3.5 years) increase the likelihood of finding meaningful results. The study includes multiple outcome measures beyond just diabetes development, including weight loss, insulin function, and cost-effectiveness. However, results are not yet available since the study only began recruitment in September 2023.
What the Results Show
This paper is a protocol (a detailed plan) for the SERENA study, not a results paper. The study is currently ongoing and results have not yet been published. The primary goal is to determine whether women receiving semaglutide injections are less likely to develop type 2 diabetes compared to women receiving placebo, measured using standard American Diabetes Association diagnostic criteria.
The study will track diabetes development over the full 3.5-year period, with clinical assessments every 6 months. Researchers will use blood tests to measure blood sugar control and other markers of metabolic health. The study is designed to have enough participants and follow-up time to detect meaningful differences between the treatment and placebo groups if semaglutide truly prevents diabetes.
Beyond preventing diabetes, the study will measure several other important outcomes: whether women need additional diabetes medications (rescue therapy), whether some women’s blood sugar returns to normal (regression to normoglycaemia), how much weight women lose, how well their bodies use insulin, and how their overall heart disease risk changes. The researchers will also evaluate patient-reported outcomes like quality of life and conduct a cost-effectiveness analysis to determine whether the medication provides good value for healthcare systems.
Previous research shows that lifestyle interventions (diet and exercise) alone have limited success in preventing type 2 diabetes after gestational diabetes, with many women still developing diabetes despite their best efforts. Semaglutide has already shown promise in preventing type 2 diabetes in people with prediabetes in other studies, but this is the first major trial specifically testing it in women during the critical postpartum period after gestational diabetes. This study fills an important gap by testing whether the medication works in this specific high-risk group.
Since this is a protocol paper rather than results, we cannot yet assess the study’s findings. However, potential limitations to consider: the study only includes women in Belgium, so results may not apply to other populations; women who volunteer for studies may be different from those who don’t; and the study relies on women following injection schedules and attending clinic visits regularly. The study is still recruiting participants and collecting data, so final results won’t be available for several years.
The Bottom Line
This study is still underway, so no clinical recommendations can be made yet. Women with a history of gestational diabetes should continue following their doctor’s advice about lifestyle changes (healthy eating, exercise, weight management) and regular blood sugar screening. If this study shows positive results, semaglutide may become an option for high-risk women in the future, but that decision should be made with a healthcare provider based on individual circumstances.
This research is most relevant to women who had gestational diabetes during pregnancy and have been diagnosed with prediabetes afterward. Healthcare providers who care for postpartum women and those with prediabetes should follow this research. Women with a family history of type 2 diabetes or those who are overweight may also find this relevant. The findings may be less directly applicable to men or to women with prediabetes from other causes.
Results from this study won’t be available for approximately 3-4 more years (the study started in September 2023 and will run for 3.5 years). Even after results are published, it typically takes 1-2 additional years for new treatments to become widely available in clinical practice. Women shouldn’t wait for these results to make lifestyle changes now, as diet and exercise remain the most accessible prevention strategies.
Frequently Asked Questions
Can semaglutide prevent type 2 diabetes after gestational diabetes?
A major Belgian trial is currently testing this question in 252 women, but results won’t be available until 2026-2027. Previous research suggests semaglutide may help prevent diabetes in high-risk groups, but this is the first large study specifically testing it in postpartum women with prediabetes.
What is gestational diabetes and why does it increase diabetes risk?
Gestational diabetes is high blood sugar that develops during pregnancy. Women who experience it have a 7-10 times higher risk of developing type 2 diabetes later because their bodies struggled to manage blood sugar during pregnancy, suggesting underlying metabolic vulnerability.
How often would I need to take semaglutide if this study shows it works?
In this study, women receive one injection per week under the skin. If approved for this use, the frequency would likely remain weekly, similar to current diabetes and weight loss applications of the medication.
Are lifestyle changes still important if I take semaglutide?
Yes. In this study, all women receive standardized lifestyle counseling regardless of whether they get semaglutide or placebo. Diet, exercise, and weight management remain essential components of diabetes prevention and work best combined with medication.
When will results from this study be available?
The SERENA study began recruiting in September 2023 and will run for 3.5 years, so primary results should be published around 2026-2027. Results will be shared through peer-reviewed journals and scientific conferences.
Want to Apply This Research?
- Track fasting blood sugar levels every 3 months and weight weekly. Users can log these measurements in the app to monitor trends and share with their healthcare provider to assess prediabetes progression
- Set reminders for weekly physical activity (150 minutes per week), daily meal logging to track carbohydrate and fiber intake, and quarterly clinic visits for blood sugar testing. The app can provide personalized feedback on lifestyle factors that influence blood sugar control
- Create a dashboard showing blood sugar trends over time, weight changes, and lifestyle adherence. Users can set goals for weight loss (5-10% reduction is often beneficial) and track whether they’re meeting physical activity targets, with alerts if blood sugar readings trend upward
This article describes a clinical trial protocol that is currently underway; results are not yet available. This information is for educational purposes only and should not be considered medical advice. Women with a history of gestational diabetes should work with their healthcare provider to develop an individualized prevention plan based on their personal risk factors and medical history. Do not start, stop, or change any medications without consulting your doctor. If you are pregnant or breastfeeding, discuss all treatment options with your healthcare provider before participating in any clinical trial.
This research translation is published by Gram Research, the science division of Gram, an AI-powered nutrition tracking app.