Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT05569772
Phase
PHASE3
Status
Recruiting
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Conditions

  • Glucose Intolerance After a Recent History of Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Gestational diabetes (GDM) is an important contributor to the increasing prevalence of type 2 diabetes (T2DM). Women with glucose intolerance in early postpartum are a particularly high-risk group with about 50% who will develop T2DM within 5 years after the delivery. Moreover, women with a history of GDM progress more rapidly to T2DM compared to women with similarly elevated glucose levels. Early intervention after the index pregnancy is therefore crucial to prevent T2DM. With the SERENA project, the investigators aim to reduce the risk to develop T2DM with the long-acting GLP-1 agonist semaglutide in women with a recent history of GDM and glucose intolerance in early postpartum.

Key Dates

Start date
Sep 14, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: semaglutide
    semaglutide SC once weekly, up titration over 2 month period to 1mg/week (0.25mg once weekly, after 4 weeks 0.5mg once weekly and after 8 weeks the maintenance dose of 1mg once weekly), treatment duration of max. 3 years
  • Placebo Comparator: placebo
    placebo SC once weekly, the same dose-escalation regimen, using matching injections, treatment duration of max. 3 years

Primary Outcome Measure

type 2 diabetes [ Time Frame: by 160 weeks ]

Central Contacts