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A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes

13. juli 2026 opdateret af: Novo Nordisk A/S

Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study

The study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes. Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. Which treatment participants get is decided by chance. UBT251 is the treatment being tested and is not yet available for doctors to prescribe, while semaglutide is a medicine used to treat type 2 diabetes that doctors can already prescribe.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
    • New South Wales
      • Castle Hill, New South Wales, Australien, 2154
        • Ikke rekrutterer endnu
        • Castle Hill Medical Centre
      • New Lambton Heights, New South Wales, Australien, 2305
        • Ikke rekrutterer endnu
        • Hunter Medical Research Institute - Endocrinology and Diabetes
      • Sydney, New South Wales, Australien, 2148
        • Ikke rekrutterer endnu
        • Roger Chih Yu Chen
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Ikke rekrutterer endnu
        • Royal Adelaide Hospital - Cardiology Department
    • Victoria
      • Melbourne, Victoria, Australien, 3004
        • Ikke rekrutterer endnu
        • Baker Heart and Diabetes Institute
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Rekruttering
        • Flourish Research
    • California
      • Fountain Valley, California, Forenede Stater, 92708
        • Rekruttering
        • Ark Clinical Research
      • Long Beach, California, Forenede Stater, 90815
        • Rekruttering
        • Ark Clinical Research
      • Los Angeles, California, Forenede Stater, 90015
        • Rekruttering
        • Los Angeles Institute for Metabolic Research
      • Montclair, California, Forenede Stater, 91763
        • Rekruttering
        • Catalina Research Institute, LLC
    • Florida
      • Hollywood, Florida, Forenede Stater, 33021
        • Rekruttering
        • Encore Medical Research LLC
      • Miramar, Florida, Forenede Stater, 33027
        • Rekruttering
        • South Broward Research LLC
      • Weston, Florida, Forenede Stater, 33331
        • Rekruttering
        • Encore Medical Research of Weston
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Ikke rekrutterer endnu
        • Midwest Inst For Clin Res
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • Rekruttering
        • Cotton O'Neil Diabetes & Endocrinology
    • Maryland
      • Oxon Hill, Maryland, Forenede Stater, 20745
        • Rekruttering
        • MD Medical Research
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27408
        • Ikke rekrutterer endnu
        • PharmQuest
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Rekruttering
        • KDCILM, LLC & Accellacare US, Inc.
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58104
        • Ikke rekrutterer endnu
        • Plains Clinical Research Center, LLC_Fargo
    • Pennsylvania
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • Rekruttering
        • Preferred Primary Care Physicians, Inc.
    • South Carolina
      • North Charleston, South Carolina, Forenede Stater, 29406
        • Rekruttering
        • Monroe Biomedical Research, LLC
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38115
        • Rekruttering
        • LifeDoc Health
    • Texas
      • Austin, Texas, Forenede Stater, 78745
        • Rekruttering
        • IMA Clinical Research
      • Houston, Texas, Forenede Stater, 77089
        • Rekruttering
        • Private Practice - Dr. Laila A. Hassan
      • Lampasas, Texas, Forenede Stater, 76550
        • Rekruttering
        • Radiance Clinical Research
      • San Antonio, Texas, Forenede Stater, 78209
        • Rekruttering
        • Quality Research Inc
      • San Antonio, Texas, Forenede Stater, 78258
        • Rekruttering
        • Tekton Research Inc
      • Shavano Park, Texas, Forenede Stater, 78231
        • Rekruttering
        • Consano Clin Res-Shavano Park
    • Utah
      • St. George, Utah, Forenede Stater, 84790
        • Rekruttering
        • Chrysalis Clinical Research
    • Washington
      • Vancouver, Washington, Forenede Stater, 98664
        • Ikke rekrutterer endnu
        • The Vancouver Clinic
  • Polen
      • Bialystok, Polen, 15-276
        • Ikke rekrutterer endnu
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Kielce, Polen, 25-355
        • Ikke rekrutterer endnu
        • Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika Piwowar
      • Lublin, Polen, 20-011
        • Ikke rekrutterer endnu
        • Clinical Best Solutions Sp. z o.o., Sp. k
      • Oświęcim, Polen, 32-600
        • Ikke rekrutterer endnu
        • Formed 2 Sp. z o.o.
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-049
        • Ikke rekrutterer endnu
        • 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-879
        • Ikke rekrutterer endnu
        • NZOZ Vita-Diabetica Malgorzata Buraczyk
  • Rumænien
      • Brasov, Rumænien, 500101
        • Ikke rekrutterer endnu
        • Mariodiab Clinic SRL
      • Bucharest, Rumænien, 013764
        • Ikke rekrutterer endnu
        • SC Nutrilife SRL
      • Galati, Rumænien, 800001
        • Ikke rekrutterer endnu
        • S.C Milena Sante SRL
      • Satu Mare, Rumænien, 440055
        • Ikke rekrutterer endnu
        • Clinica Korall S.R.L. Satu Mare
      • Timișoara, Rumænien, 300723
        • Ikke rekrutterer endnu
        • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
    • Dolj
      • Craiova, Dolj, Rumænien, 200515
        • Ikke rekrutterer endnu
        • S.C. Top Diabet Srl
  • Slovakiet
      • Bratislava, Slovakiet, 851 01
        • Ikke rekrutterer endnu
        • MEDISPEKTRUM s.r.o.
      • Lučenec, Slovakiet, 984 01
        • Ikke rekrutterer endnu
        • IN-DIA s.r.o.
      • Sabinov, Slovakiet, 08301
        • Ikke rekrutterer endnu
        • MEDI-DIA s.r.o.
      • Trebišov, Slovakiet, 075 01
        • Ikke rekrutterer endnu
        • ARETEUS s.r.o.
  • Spanien
      • Barcelona, Spanien, 08035
        • Ikke rekrutterer endnu
        • Hospital Vall d'Hebron
      • Centelles (Barcelona), Spanien, 08540
        • Ikke rekrutterer endnu
        • Eap Osona Sud Alt Congost S.L.P
      • Madrid, Spanien, 28006
        • Ikke rekrutterer endnu
        • Hospital Universitario de la Princesa
      • Santander, Spanien, 39008
        • Ikke rekrutterer endnu
        • Hospital Universitario Marques De Valdecilla
      • Seville, Spanien, 41010
        • Ikke rekrutterer endnu
        • H. Infanta Luisa_Endocrino y Obesidad
    • Barcelona
      • Vic, Barcelona, Spanien, 08500
        • Ikke rekrutterer endnu
        • Equip D'assistencia Primaria Vic S.L.P.
  • Sydkorea
      • Gwangju, Sydkorea, 61453
        • Ikke rekrutterer endnu
        • Chosun University Hospital_Endocrinology
      • Seoul, Sydkorea, 05505
        • Ikke rekrutterer endnu
        • Asan Medical Center_Endocrinology
      • Seoul, Sydkorea, 06591
        • Ikke rekrutterer endnu
        • The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
      • Seoul, Sydkorea, 08308
        • Ikke rekrutterer endnu
        • Korea University Guro Hospital_Endocrinology
  • Tyskland
      • Bad Oeynhausen, Tyskland, 32545
        • Ikke rekrutterer endnu
        • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
      • Berlin, Tyskland, 13597
        • Ikke rekrutterer endnu
        • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
      • Bochum, Tyskland, 44869
        • Ikke rekrutterer endnu
        • DSP Bochum, Diabetes- und Stoffwechselpraxis
      • Bünde, Tyskland, 32257
        • Ikke rekrutterer endnu
        • Studiengesellschaft Dres. Könemann/Steinmann GbR
      • Essen, Tyskland, 45136
        • Ikke rekrutterer endnu
        • InnoDiab Forschung GmbH
      • Hof, Tyskland, 95030
        • Ikke rekrutterer endnu
        • Mesut Durmaz, Hof
      • Mannheim, Tyskland, 68167
        • Ikke rekrutterer endnu
        • CRS Clinical Research Mannheim GmbH (hVIVO Mannheim)
    • Bavaria
      • Amberg, Bavaria, Tyskland, 92224
        • Ikke rekrutterer endnu
        • Versdias - Diabetologikum Amberg
  • Ungarn
      • Budapest, Ungarn, 1083
        • Ikke rekrutterer endnu
        • Semmelweis Egyetem
      • Budapest, Ungarn, 1032
        • Ikke rekrutterer endnu
        • Szent Margit Rendelőintézet Nonprofit Kft.
      • Budapest, Ungarn, 1102
        • Ikke rekrutterer endnu
        • PVN Kutató Kft.
      • Pécs, Ungarn, 7624
        • Ikke rekrutterer endnu
        • Pécsi Tudományegyetem ÁOK
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Ungarn, 6725
        • Ikke rekrutterer endnu
        • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male or female (sex assigned at birth, inclusive of all gender identities).
  • Age 18-75 years (both inclusive) at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes greater than or equal to (≥) 180 days before screening.
  • Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:

metformin with or without sodium-glucose cotransporter-2 (SGLT2) inhibitor.

  • HbA1c of 7.0-10.5 percent (%) (53-91 millimoles per mole (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
  • Body mass index between 25.0 kg/m^2 and 50.0 kg/m^2 (both inclusive) at screening.

Exclusion Criteria:

  • Treatment with any medication (prescription or over-the counter) or alternative remedies for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire, question 8.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: UBT251
Participants will receive once weekly UBT251 subcutaneously.
Medicin: UBT251
UBT251 will be administered subcutaneously once-weekly.
Placebo komparator: UBT251 Placebo
Participants will receive once weekly UBT251 placebo subcutaneously.
Medicin: UBT251 Placebo
UBT251 placebo will be administered subcutaneously once-weekly.
Aktiv komparator: Semaglutide
Participants will receive once weekly semaglutide subcutaneously.
Medicin: Semaglutide
Semaglutide will be administered subcutaneously once-weekly.
Placebo komparator: Semaglutide Placebo
Participants will receive once weekly semaglutide placebo subcutaneously.
Medicin: Semaglutide Placebo
Semaglutide placebo will be administered subcutaneously once-weekly.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
UBT251: Change in glycated haemoglobin (HbA1c)
Tidsramme: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Measured as percentage (%)-point.
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
UBT251: Relative change in body weight
Tidsramme: From baseline (week 0) to week 40
Measured as %.
From baseline (week 0) to week 40
UBT251: Change in body weight
Tidsramme: From baseline (week 0) to week 40
Measured as kilogram (kg).
From baseline (week 0) to week 40
UBT251 vs placebo: Change in HbA1c
Tidsramme: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Measured as %-point.
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Change in HbA1c
Tidsramme: From baseline (week 0) to week 40
Measured as %-point.
From baseline (week 0) to week 40
Change in homeostasis model assessment of insulin resistance (HOMA2-IR)
Tidsramme: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in homeostasis model assessment of beta-cell function (HOMA2-B)
Tidsramme: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in fasting plasma glucose (FPG)
Tidsramme: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Measured as millimoles per litre (mmol/L).
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 milligrams per deciliter (mg/dL))
Tidsramme: From baseline (week -2 to week 0) to week 14- 16, week 26-28 and week 38-40, respectively
Measured as %-points.
From baseline (week -2 to week 0) to week 14- 16, week 26-28 and week 38-40, respectively
UBT251 vs placebo: Relative change in body weight
Tidsramme: From baseline (week 0) to week 40
Measured as %.
From baseline (week 0) to week 40
UBT251 vs placebo: Change in body weight
Tidsramme: From baseline (week 0) to week 40
Measured as kg.
From baseline (week 0) to week 40
Change in body mass index (BMI)
Tidsramme: From baseline (week 0) to week 40
Measured as Kilograms per square meter (kg/m^2).
From baseline (week 0) to week 40
Change in waist circumference
Tidsramme: From baseline (week 0) to week 40
Measured as centimeter (cm).
From baseline (week 0) to week 40
Change in waist-to-height ratio (WHtR)
Tidsramme: From baseline (week 0) to week 40
From baseline (week 0) to week 40
Change in systolic blood pressure (SBP)
Tidsramme: From baseline (week 0) to week 40
Measured as millimetres of mercury (mmHg).
From baseline (week 0) to week 40
Change in diastolic blood pressure (DBP)
Tidsramme: From baseline (week 0) to week 40
Measured as mmHg.
From baseline (week 0) to week 40
Change in pulse rate
Tidsramme: From baseline (week 0) to week 40
Measured in beats/min.
From baseline (week 0) to week 40
Change in high sensitivity C-Reactive Protein (hsCRP)
Tidsramme: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in total cholesterol
Tidsramme: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in high-density lipoprotein (HDL) cholesterol
Tidsramme: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in low-density lipoprotein (LDL) cholesterol
Tidsramme: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in triglycerides
Tidsramme: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in urine albumin creatinine ratio (UACR)
Tidsramme: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Measured as ratio to baseline.
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Change in eGFR (creatinine-cystatin C-based CKD-EPI 2021)
Tidsramme: From baseline (week 0) to week 40
Measured in milliliters per minute per 1.73 square meters (mL/min/1.73 m^2).
From baseline (week 0) to week 40
Number of treatment-emergent adverse events (TEAEs)
Tidsramme: From baseline (week 0) to week 46
Measured as number of events.
From baseline (week 0) to week 46

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Efterforskere

  • Studieleder: Clinical Transparency dept. 2834, Novo Nordisk A/S

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juni 2026

Primær færdiggørelse (Anslået)

4. oktober 2027

Studieafslutning (Anslået)

15. november 2027

Datoer for studieregistrering

Først indsendt

19. juni 2026

Først indsendt, der opfyldte QC-kriterier

19. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN9559-8577
  • U1111-1329-7014 (Anden identifikator: World Health Organization (WHO))
  • 2026-525465-42 (Anden identifikator: European Medical Agency (EMA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med UBT251

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malawi

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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