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

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Woman's
Study ID
NCT04873050
Phase
PHASE4
Status
Recruiting
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Conditions

  • Postpartum Disorder
  • Pre Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide Pen Injector [Ozempic] — DRUG
    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
  • Placebo semaglutide pen injector — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 13, 2022
Status verified
Mar 2025
Primary completion
Jan 1, 2026
Completion
Mar 1, 2026

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide Pen Injector (Ozempic)
    Weekly injections of semaglutide for 8 months total (2 months of titration; 6 months of full dose- 1mg/week)
  • Sham Comparator: Placebo
    Weekly injections of placebo for 8 months total

Primary Outcome Measure

Regression to normoglycemia [ Time Frame: After 24 weeks of full-dose treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Woman's HospitalBaton RougeLouisiana70817
Elizabeth Sutton, PhD
[email protected]
225-924-8446

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By research site
Woman's Hospital· Baton Rouge, LA

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