A Randomized, Placebo-controlled, Double Blind Trial of Semaglutide 1mg (Ozempic®) on Regression to Normoglycemia in WomEn with a Recent History of Gestational DiabETes Mellitus: the SWEET Study
The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and reduce future risk of T2DM in young women.
• Female
• 18 - 45 years old (inclusive)
• History of gestational diabetes in most recent pregnancy
• 6 months - 10 years postpartum
• BMI ≥ 25 kg/m2
• Use of long-acting reversible contraception or bilateral tubal ligation
• Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT):
∙ Fasting glucose 100-125mg/dL (inclusive) and/or
‣ 120 minute glucose 140-199mg/dL (inclusive)
• Willingness to maintain physical activity level throughout study duration
• Willingness to standardize diet for 3 days prior to OGTT
⁃ Ability to provide informed consent before any trial-related activities