Study of Semaglutide Injection Compared to Placebo for Glucose Intolerance in Women After Gestational Diabetes

What this Trial Is About

Researchers are studying women with a recent history of gestational diabetes GDM who have persistent glucose intolerance early after childbirth. These women are at high risk of developing type 2 diabetes T2DM, with about half progressing within five years. The study aims to evaluate whether the long-acting drug semaglutide can reduce the risk of developing T2DM compared to a placebo in this group. Women will be randomly assigned to receive either semaglutide or a placebo injection once weekly, alongside lifestyle advice. Semaglutide will be gradually increased to a 1mg weekly dose over eight weeks and continued for up to three years. After stopping the study medication, participants will have an oral glucose tolerance test 3 to 6 months later. The study is conducted across several centers and follows participants for a total of about three years. During the study, participants will have regular assessments measuring blood sugar control, body weight, insulin function, heart and metabolic health, and quality of life using questionnaires. Blood tests will monitor glucose, insulin sensitivity, cholesterol, and other biomarkers. Researchers will track the development of T2DM, need for additional diabetes treatments, and weight changes. Health economic factors and patient satisfaction will also be evaluated. The study includes thorough safety and follow-up evaluations lasting beyond the treatment period.

Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes