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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

19 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

300

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: UBT251
Participants will receive once weekly UBT251 subcutaneously.
Droga: UBT251
UBT251 will be administered subcutaneously once-weekly.
Comparatore placebo: UBT251 Placebo
Participants will receive once weekly UBT251 placebo subcutaneously.
Droga: UBT251 Placebo
UBT251 placebo will be administered subcutaneously once-weekly.
Comparatore attivo: Semaglutide
Participants will receive once weekly semaglutide subcutaneously.
Droga: Semaglutide
Semaglutide will be administered subcutaneously once-weekly.
Comparatore placebo: Semaglutide Placebo
Participants will receive once weekly semaglutide placebo subcutaneously.
Droga: Semaglutide Placebo
Semaglutide placebo will be administered subcutaneously once-weekly.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
UBT251: Change in glycated haemoglobin (HbA1c)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
UBT251: Relative change in body weight
Lasso di tempo: From baseline (week 0) to week 40
Measured as %.
From baseline (week 0) to week 40
UBT251: Change in body weight
Lasso di tempo: From baseline (week 0) to week 40
Measured as kilogram (kg).
From baseline (week 0) to week 40
UBT251 vs placebo: Change in HbA1c
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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))
Lasso di tempo: 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
Lasso di tempo: From baseline (week 0) to week 40
Measured as %.
From baseline (week 0) to week 40
UBT251 vs placebo: Change in body weight
Lasso di tempo: From baseline (week 0) to week 40
Measured as kg.
From baseline (week 0) to week 40
Change in body mass index (BMI)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: From baseline (week 0) to week 40
From baseline (week 0) to week 40
Change in systolic blood pressure (SBP)
Lasso di tempo: 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)
Lasso di tempo: From baseline (week 0) to week 40
Measured as mmHg.
From baseline (week 0) to week 40
Change in pulse rate
Lasso di tempo: 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)
Lasso di tempo: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in total cholesterol
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in triglycerides
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: From baseline (week 0) to week 46
Measured as number of events.
From baseline (week 0) to week 46

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novo Nordisk A/S

Investigatori

  • Direttore dello studio: Clinical Transparency dept. 2834, Novo Nordisk A/S

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

22 giugno 2026

Completamento primario (Stimato)

4 ottobre 2027

Completamento dello studio (Stimato)

15 novembre 2027

Date di iscrizione allo studio

Primo inviato

19 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 giugno 2026

Primo Inserito (Effettivo)

25 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

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Sedi

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