NCT04873050

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Woman's · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The diagnosis of gestational diabetes mellitus (GDM) during pregnancy identifies young women with abnormalities in pancreatic beta cell function that worsen over time, leading to diabetes. It is estimated that between 15% and 70% of women with a history GDM will progress to type 2 diabetes mellitus (T2DM). However, upon an impaired glucose tolerance test result in the early postpartum period, the American College of Obstetricians and Gynecologists only recommend considering referral for management, weight loss and physical activity counseling, considering metformin if testing results are severe enough, and yearly assessment of glycemic status. In many cases, it is possible to reverse diabetes by losing weight in the early stages before permanent, systemic damage occurs. Therefore, there is a dire need for efficacious pharmacologic intervention options in this period of postpartum diabetes recovery to return women to normoglycemia and lower future T2DM risk. Weight loss and medications that mitigate impairments in insulin secretion show the best promise for delaying or preventing T2DM, the dominant form of diabetes that develops after GDM. The primary study objective is "to examine the efficacy of semaglutide 1mg compared to placebo on regression to normoglycemia in women with dysglycemia and a recent history of gestational diabetes mellitus (i.e., 6-36 months postpartum)" to answer the research question of: "Among women with dysglycemia and a recent history of gestational diabetes mellitus, can acute treatment of semaglutide 1mg lead to regression to normoglycemia?"

Conditions

• Pre Diabetes
• Postpartum Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-13
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2021-05-05
• Last updated: 2025-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study