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Semaglutid for behandling av glukoseintoleranse hos kvinner med tidligere svangerskapsdiabetes (SERENA)

11. september 2026 oppdatert av: Universitaire Ziekenhuizen KU Leuven

Semaglutid for behandling av glukoseintoleranse hos kvinner med tidligere svangerskapsdiabetes: en dobbeltblind RCT

Svangerskapsdiabetes (GDM) er en viktig bidragsyter til den økende prevalensen av type 2 diabetes (T2DM). Kvinner med glukoseintoleranse tidlig etter fødsel er en spesielt høyrisikogruppe med ca 50 % som vil utvikle T2DM innen 5 år etter fødselen. Dessuten utvikler kvinner med en historie med GDM raskere til T2DM sammenlignet med kvinner med tilsvarende forhøyede glukosenivåer. Tidlig intervensjon etter indeksgraviditeten er derfor avgjørende for å forhindre T2DM. Med SERENA-prosjektet tar vi derfor sikte på å redusere risikoen for å utvikle T2DM med den langtidsvirkende GLP-1-agonisten semaglutid hos kvinner med en nylig historie med GDM og glukoseintoleranse tidlig etter fødsel.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Pasientpopulasjon: Kvinner med en nylig historie med svangerskapsdiabetes (GDM) og vedvarende glukoseintoleranse tidlig etter fødsel er en spesielt høyrisikogruppe, med ca. 50 % som utvikler type 2 diabetes (T2DM) innen 5 år etter fødselen. Semaglutid er en langtidsvirkende glukagon-lignende peptid-1 (GLP-1) agonist med flere gunstige metabolske effekter, inkludert glukosesenkende effekt, vekttap og kardiovaskulære beskyttende effekter. Vi antar at hos kvinner med tidligere GDM og glukoseintoleranse i tidlig postpartum, vil behandling med semaglutid redusere risikoen for å utvikle T2DM på lang sikt sammenlignet med placebo.

Intervensjon og sammenligning: Belgisk multisentrisk dobbeltblind RCT med 12 sentre for å sammenligne semaglutid (en gang ukentlig) med placebo hos kvinner med en nylig historie med GDM og glukoseintoleranse [nedsatt fastende glykemi (IFG) og/eller nedsatt glukosetoleranse (IGT) ] 6-24 uker etter fødsel. Deltakerne vil bli 1/1 randomisert til semaglutid eller placebo på bakgrunn av livsstilstiltak. Semaglutid vil bli opptitrert til 1 mg/uke over en 8-ukers periode. Deltakerne vil bli fulgt opp i 3 år. Deltakerne vil motta en 75 g oral glukosetoleransetest (OGTT) 3 måneder etter at intervensjonen er stoppet. Randomisering vil bli stratifisert i henhold til BMI ved tidlig postpartum besøk (

Utfall: Det primære endepunktet er utviklingen av T2DM definert av OGTT og/eller HbA1c. Viktige sekundære endepunkter inkluderer behovet for redningsterapi for diabetes, regresjon til normoglykemi, vekttap, beta-cellefunksjon, insulinresistens og det metabolske syndromet. For å oppnå 80 % kraft, planlegger vi en prøvestørrelse på 206 for å oppdage en estimert 50 % reduksjon i risikoen for å utvikle T2DM mellom begge grupper, forutsatt et tap på 30 % til oppfølging i løpet av studien.

Studietype

Intervensjonell

Registrering (Antatt)

252

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Belgia
      • Aalst, Belgia
        • Rekruttering
        • AZORG
        • Ta kontakt med:
          • Katrien Wierckx
      • Antwerp, Belgia
        • Rekruttering
        • UZA
        • Ta kontakt med:
          • Niels Bochanen
      • Antwerp, Belgia
        • Rekruttering
        • ZAS
        • Ta kontakt med:
          • Ann Verhaegen
      • Bruges, Belgia
      • Brussels, Belgia
        • Rekruttering
        • UZ Brussel
        • Ta kontakt med:
          • Nancy Van Wilder
      • Brussels, Belgia
        • Rekruttering
        • Erasme
        • Ta kontakt med:
          • Maria Lytrivi
      • Ieper, Belgia
        • Rekruttering
        • Jan Yperman
        • Ta kontakt med:
      • Kortrijk, Belgia
        • Rekruttering
        • AZ Groeninge Kortrijk
        • Ta kontakt med:
          • Gertjan Vereecke
      • Leuven, Belgia
        • Rekruttering
        • UZ Leuven
        • Ta kontakt med:
          • Katrien Benhalima
      • Liège, Belgia
        • Rekruttering
        • CHU de Liege
        • Ta kontakt med:
          • JC Philips
      • Mouscron, Belgia
        • Rekruttering
        • Centre Hospitalier Mouscron
        • Ta kontakt med:
          • Philippe Oriot
      • Sint-Niklaas, Belgia
        • Rekruttering
        • Vitaz
        • Ta kontakt med:
          • Peter Coremans
      • Turnhout, Belgia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  1. Frivillig skriftlig informert samtykke fra deltakeren er innhentet før eventuelle screeningprosedyrer
  2. Bruk av svært effektive prevensjonsmetoder
  3. Anamnese med GDM (diagnostisert med 2013 WHO-kriterier 24-32 uker av svangerskapet) og glukoseintoleranse 6-24 uker postpartum (basert på ADA-kriteriene)
  4. Trenger å kunne forstå og snakke nederlandsk, fransk eller engelsk

Ekskluderingskriterier:

  • 1. Deltakeren har en historie med alle typer diabetes eller autoantistoffer for type 1 diabetes, historie med pankreatitt, familie eller personlig historie med medullært skjoldbruskkjertelkarsinom eller multippel endokrin neoplasi syndrom type 2, alvorlig psykiatrisk lidelse det siste året, hjertesvikt NYHA klasse 4, sluttstadium nyresykdom (eGFR

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: semaglutid
semaglutid SC én gang ukentlig, opp titrering over 2 måneder til 1 mg/uke (0,25 mg én gang ukentlig, etter 4 uker 0,5 mg én gang ukentlig og etter 8 uker vedlikeholdsdosen på 1 mg én gang ukentlig), behandlingsvarighet på maks. 3 år
Legemiddel: Semaglutid penninjektor
vedlikeholdsdose på 1 mg SC en gang i uken
Andre navn:
  • Ozempisk
Placebo komparator: placebo
placebo SC én gang ukentlig, samme doseøkningsregime, ved bruk av matchende injeksjoner, behandlingsvarighet på maks. 3 år
Legemiddel: Semaglutid placebo
vedlikeholdsdose på 1 mg SC en gang i uken

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Development of T2DM
Tidsramme: by 160 weeks
Defined by FPG, OGTT, and/or HbA1c according to the ADA criteria
by 160 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Need for glucose-lowering (rescue) therapy
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage need for rescue therapy for diabetes
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Frequency of prediabetes based on FPG, OGTT, and/or HbA1c
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage of prediabetes based on FPG, OGTT, and/or HbA1c
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Regression to normoglycaemia
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage regression to normoglycaemia, based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Change in body weight
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Change in body weight (kg)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
BMI
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Mean BMI (Kg/m2)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist circumference
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Mean waist circumference (cm)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist-to-hip ratio
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist/hip circumference ratio
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥5% weight loss
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage weight loss ≥5%
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥10% weight loss
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage weight loss ≥10%
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥15% weight loss
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage weight loss ≥15%
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Body fat percentage assessed by bioelectrical impedance analysis (Bodystat 1500®)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage body fat measured by bioelectrical impedance analysis
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
β-cell function, assessed by HOMA-B
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by the HOMA-B index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulinogenic index divided by HOMA-IR
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by the by the insulinogenic index divided by HOMA-insulin resistance index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin secretion-sensitivity index-2
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by theby the insulin-secretion sensitivity-2 index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Stumvoll index
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by the Stumvoll index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin sensitivity, assessed by the Matsuda index (reflecting whole body insulin sensitivity)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Whole body Insulin sensitivity measured by the insulin sensitivity index of Matsuda
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
1/HOMA-IR, reflecting primarily hepatic insulin sensitivity
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
The reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Prevalence of the metabolic syndrome
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage of the metabolic syndrome based on the WHO criteria
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Blood pressure (blood pressure ≥140/90 mmHg)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage blood pressure ≥140/90mmHg
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Heart rate
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Mean heart rate
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including low density lipoprotein-cholesterol (LDL-cholesterol, ≥100 mg/dL or ≥2,6 mmol/L)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage LDL cholesterol ≥100mg/dl or ≥2,6 mmol/L
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including triglycerides (≥150 mg/dL or ≥1,7 mmol/L)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage triglycerides ≥150mg/dl or ≥1,7 mmol/L
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by SF-36
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by EQ-5D-5L
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale (EQ VAS). Scores range from 0 to 100, with higher scores indicating better perceived health status
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of depression (CES-D)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Depressive symptoms assessed using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Total scores range from 0 to 60, with higher scores indicating more depressive symptoms
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of anxiety (short-form STAI)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of anxiety assessed using the 6-item short-form State-Trait Anxiety Inventory (STAI). Total scores range from 20 to 80 after score transformation, with higher scores indicating greater anxiety symptoms
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Treatment satisfaction assessed using a study-specific questionnaire based on the Diabetes Treatment Satisfaction Questionnaire
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Diabetes risk perception assessed using the Diabetes Risk Perception Questionnaire, a validated questionnaire that evaluates perceived risk of developing diabetes
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Sleep quality (Pittsburgh Sleep Quality Index)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Sleep quality assessed using the validated Pittsburgh Sleep Quality Index (PSQI)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Food security (short-form HFSSM)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Food security assessed using the short-form Household Food Security Survey Module (HFSSM). Scores indicate the level of food security, with higher scores reflecting greater food insecurity
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Plasma metabolite concentrations
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Changes in and associations of metabolomic profiles, with cardiometabolic risk and treatment response. Assessed using metabolomic profiling. Blood samples will be collected at baseline and every 6 months during a 3.5-year follow-up period (study visits).
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Quality-adjusted life years (QALYs)
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Quality-adjusted life years (QALYs), calculated as the area under the curve of health-related quality of life utility values over time, where higher values indicate better health outcomes
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide compared with placebo
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide versus placebo
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental healthcare costs
Tidsramme: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental healthcare costs associated with the intervention compared with control, calculated from collected healthcare resource utilization and unit cost data. Currency (e.g., EUR per participant)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Samarbeidspartnere

Universitair Ziekenhuis Brussel
University Hospital, Antwerp
Onze Lieve Vrouw Hospital
General Hospital Groeninge
AZ Turnhout
Erasme University Hospital
AZ Sint-Lucas Brugge
Centre Hospitalier Universitaire de Liege
Vitaz
Centre Hospitalier Mouscron
Jan Yperman Ziekenhuis
Ziekenhuis aan de Stroom

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. september 2023

Primær fullføring (Antatt)

1. mars 2030

Studiet fullført (Antatt)

1. mai 2030

Datoer for studieregistrering

Først innsendt

28. september 2022

Først innsendt som oppfylte QC-kriteriene

3. oktober 2022

Først lagt ut (Faktiske)

6. oktober 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • S66967
  • 2022-502082-22-00 (Annen identifikator: EU CT number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data will be made available upon reasonable request after study completion, database lock, unblinding, and publication of the primary results, subject to applicable ethical, legal, and data protection requirements.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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