Treatment to Regress to Normoglycemia in Women with a Recent History of GDM
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWoman's
About this trial
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 criteria
Qualifiers
Female
18 - 45 years old (inclusive)
History of gestational diabetes in most recent pregnancy
6 months - 10 years postpartum
Disqualifiers
Body weight > 350lb
Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures.
Breastfeeding within 3 months of screening visit 1
Post-menopausal
Trial design
Treatments tested in this trial
- Semaglutide Pen Injector [Ozempic]
- Placebo semaglutide pen injector
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
Woman's
Lead sponsor
Novo Nordisk A/S
Collaborator
Source ClinicalTrials.gov