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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат UBT251
  UBT251 will be administered subcutaneously once-weekly.
• Препарат UBT251 Placebo
  UBT251 placebo will be administered subcutaneously once-weekly.
• Препарат Semaglutide
  Semaglutide will be administered subcutaneously once-weekly.
• Препарат Semaglutide Placebo
  Semaglutide placebo will be administered subcutaneously once-weekly.

Первичные конечные точки

• UBT251: Change in glycated haemoglobin (HbA1c) [Срок оценки: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)]

Вторичные конечные точки (12)

• UBT251: Relative change in body weight [Срок оценки: From baseline (week 0) to week 40]
• UBT251: Change in body weight [Срок оценки: From baseline (week 0) to week 40]
• UBT251 vs placebo: Change in HbA1c [Срок оценки: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)]
• Change in HbA1c [Срок оценки: From baseline (week 0) to week 40]
• Change in homeostasis model assessment of insulin resistance (HOMA2-IR) [Срок оценки: From baseline (week 0) to week 40]
• Change in homeostasis model assessment of beta-cell function (HOMA2-B) [Срок оценки: From baseline (week 0) to week 40]
• Change in fasting plasma glucose (FPG) [Срок оценки: 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)) [Срок оценки: 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 [Срок оценки: From baseline (week 0) to week 40]
• UBT251 vs placebo: Change in body weight [Срок оценки: From baseline (week 0) to week 40]
• Change in body mass index (BMI) [Срок оценки: From baseline (week 0) to week 40]
• Change in waist circumference [Срок оценки: From baseline (week 0) to week 40]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 25 центров

• Flourish Research — Birmingham
• Ark Clinical Research — Fountain Valley
• Ark Clinical Research — Long Beach
• Los Angeles Institute for Metabolic Research — Los Angeles
• Catalina Research Institute, LLC — Montclair
• Encore Medical Research LLC — Hollywood
• South Broward Research LLC — Miramar
• Encore Medical Research of Weston — Weston
• … и ещё 17 центров

Германия · 8 центров

• Versdias - Diabetologikum Amberg — Amberg
• Herz- und Diabeteszentrum NRW - Bad Oeynhausen — Bad Oeynhausen
• Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR — Berlin
• DSP Bochum, Diabetes- und Stoffwechselpraxis — Bochum
• Studiengesellschaft Dres. Könemann/Steinmann GbR — Bünde
• InnoDiab Forschung GmbH — Essen
• Mesut Durmaz, Hof — Hof
• CRS Clinical Research Mannheim GmbH (hVIVO Mannheim) — Mannheim

Польша · 6 центров

• 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ — Lublin
• NZOZ Vita-Diabetica Malgorzata Buraczyk — Bialystok
• Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok
• Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika P — Kielce
• Clinical Best Solutions Sp. z o.o., Sp. k — Lublin
• Formed 2 Sp. z o.o. — Oświęcim

Румыния · 6 центров

• S.C. Top Diabet Srl — Craiova
• Mariodiab Clinic SRL — Brasov
• SC Nutrilife SRL — Bucharest
• S.C Milena Sante SRL — Galati
• Clinica Korall S.R.L. Satu Mare — Satu Mare
• Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara — Timișoara

Испания · 6 центров

• Equip D'assistencia Primaria Vic S.L.P. — Vic
• Hospital Vall d'Hebron — Barcelona
• Eap Osona Sud Alt Congost S.L.P — Centelles (Barcelona)
• Hospital Universitario de la Princesa — Madrid
• Hospital Universitario Marqués de Valdecilla — Santander
• H. Infanta Luisa_Endocrino y Obesidad — Seville

Австралия · 5 центров

• Castle Hill Medical Centre — Castle Hill
• Hunter Medical Research Institute - Endocrinology and Diabetes — New Lambton Heights
• Roger Chih Yu Chen — Sydney
• Royal Adelaide Hospital - Cardiology Department — Adelaide
• Baker Heart and Diabetes Institute — Melbourne

Венгрия · 5 центров

• Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ — Szeged
• Szent Margit Rendelőintézet Nonprofit Kft. — Budapest
• Semmelweis Egyetem — Budapest
• PVN Kutató Kft. — Budapest
• Pécsi Tudományegyetem ÁOK — Pécs

Словакия · 4 центра

• MEDISPEKTRUM s.r.o. — Bratislava
• IN-DIA s.r.o. — Lučenec
• MEDI-DIA s.r.o. — Sabinov
• ARETEUS s.r.o. — Trebišov

South Korea · 4 центра

• Chosun University Hospital_Endocrinology — Gwangju
• Asan Medical Center_Endocrinology — Seoul
• The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology — Seoul
• Korea University Guro Hospital_Endocrinology — Seoul

Идентификаторы

NCT: NCT07668388 · NN9559-8577 · U1111-1329-7014 · 2026-525465-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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