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RECRUITING
NCT04873050
PHASE4

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

Sponsor: Woman's

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2022-01-13

Completion Date

2026-03-01

Last Updated

2025-03-13

Healthy Volunteers

Yes

Interventions

DRUG

Semaglutide 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

DRUG

Placebo 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