Health TrialsbyHealthPanel

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

ConditionsPre DiabetesPostpartum Disorder
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Semaglutide Pen Injector (Ozempic)Experimental treatment 1 intervention
Group B: PlaceboSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Regression to normoglycemia

Glucose tolerance to be determined by glycemic response to a 75 gram, two-hour oral glucose tolerance test (OGTT). Regression to normoglycemia is defined by fasting glucose \<100mg/dL and 120 minute glucose \<140 mg/dL

Time frame
After 24 weeks of full-dose treatment

Secondary outcomes

1

Change in HbA1c

Hemoglobin to be determined

Time frame
After 24 weeks of full-dose treatment
2

Change in body weight

Fasted body weight after intervention minus fasted body weight at enrollment

Time frame
After 24 weeks of full-dose treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Woman's

Lead sponsor

Novo Nordisk A/S

Collaborator

Source ClinicalTrials.gov
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