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Recruiting Phase 3

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

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About this study

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.

Condition
Glucose Intolerance After a Recent History of Gestational Diabetes
Tested
Semaglutide Pen Injector, Semaglutide placebo
Sponsor
Universitaire Ziekenhuizen KU Leuven

Who can join

Age
18 years and older
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Eligible sex: Female
  • Study condition: Glucose Intolerance After a Recent History of Gestational Diabetes
  • Eligible participants are women aged ≥18 years, with a history of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or \<24 weeks for early GDM).
  • Participants must have prediabetes diagnosed between 6 weeks and 12 months postpartum according to ADA criteria (FPG 5.6-6.9 mmol/L, 2-hour OGTT glucose 7.8-11.0 mmol/L and/or HbA1c 39-46 mmol/mol \[5.7-6.4%\]).
  • Additional inclusion criteria include cessation of breastfeeding, no intention to become pregnant within the next year, use of effective contraception and no use of medication affecting glucose metabolism. Written ICF is obtained prior to any study-related procedures.

Where

13 sites, 13 recruiting

AZORG

Aalst, Belgium

Recruiting

UZA

Antwerp, Belgium

Recruiting

ZAS

Antwerp, Belgium

Recruiting

AZ St Jan Brugge

Bruges, Belgium

Recruiting

Erasme

Brussels, Belgium

Recruiting

UZ Brussel

Brussels, Belgium

Recruiting

and 7 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.