RecruitingPhase 4NCT04873050

Treatment to Regress to Normoglycemia in Women with a Recent History of GDM

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


Sponsor

Woman's

Enrollment

102 participants

Start Date

Jan 13, 2022

Study Type

INTERVENTIONAL

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether semaglutide 1 mg (Ozempic), a weekly injectable medication, can help women who had gestational diabetes during pregnancy return to normal blood sugar levels in the months after delivery. Women with gestational diabetes have an elevated risk — up to 70% — of developing type 2 diabetes later in life, and this study aims to find an effective medication to reduce that risk during the postpartum period. Women aged 18 to 45 who had gestational diabetes in their most recent pregnancy, are 6 months to 10 years postpartum, have a BMI of 25 or higher, and show early signs of blood sugar problems (but not yet full diabetes) are eligible — those who are pregnant, breastfeeding, or have significant health conditions are excluded. Participation involves weekly semaglutide or placebo injections for the study duration, with glucose testing and regular clinic visits. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSemaglutide Pen Injector [Ozempic]

Start injection of semaglutide 0.25mg subcutaneously (SC) once a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses

DRUGPlacebo semaglutide pen injector

Start injection of placebo semaglutide 0.25mg subcutaneously (SC) one a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses


Locations(1)

Woman's Hospital

Baton Rouge, Louisiana, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04873050