Clinical trial

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

Recruiting now · Phase 2 · 8 countries · Registry ID NCT07668388

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionDiabetes Mellitus, Type 2

Full registry criteria

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.

Treatments and study arms

UBT251

Drug

UBT251 will be administered subcutaneously once-weekly.

UBT251 Placebo

Drug

UBT251 placebo will be administered subcutaneously once-weekly.

Semaglutide

Drug

Semaglutide will be administered subcutaneously once-weekly.

Semaglutide Placebo

Drug

Semaglutide placebo will be administered subcutaneously once-weekly.

Primary outcomes

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

Measured as percentage (%)-point.

Study locations

70 locations were listed when this page was built. The first 40 are shown.

Royal Adelaide Hospital - Cardiology Department🇦🇺 Adelaide, South Australia, Australia
Castle Hill Medical Centre🇦🇺 Castle Hill, New South Wales, Australia
Novatrials🇦🇺 Charlestown, New South Wales, Australia
Baker Heart and Diabetes Institute🇦🇺 Melbourne, Victoria, Australia
Hunter Medical Research Institute - Endocrinology and Diabetes🇦🇺 New Lambton Heights, New South Wales, Australia
Roger Chih Yu Chen🇦🇺 Sydney, New South Wales, Australia
Versdias - Diabetologikum Amberg🇩🇪 Amberg, Bavaria, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen🇩🇪 Bad Oeynhausen, Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR🇩🇪 Berlin, Germany
DSP Bochum, Diabetes- und Stoffwechselpraxis🇩🇪 Bochum, Germany
Studiengesellschaft Dres. Könemann/Steinmann GbR🇩🇪 Bünde, Germany
InnoDiab Forschung GmbH🇩🇪 Essen, Germany
Mesut Durmaz, Hof🇩🇪 Hof, Germany
CRS Clinical Research Mannheim GmbH (hVIVO Mannheim)🇩🇪 Mannheim, Germany
PVN Kutató Kft.🇭🇺 Budapest, Hungary
Semmelweis Egyetem🇭🇺 Budapest, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.🇭🇺 Budapest, Hungary
Pécsi Tudományegyetem ÁOK🇭🇺 Pécs, Hungary
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ🇭🇺 Szeged, Csongrád-Csanád, Hungary
NZOZ Vita-Diabetica Malgorzata Buraczyk🇵🇱 Bialystok, Podlaskie Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku🇵🇱 Bialystok, Poland
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika Piwowar🇵🇱 Kielce, Poland
1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ🇵🇱 Lublin, Lublin Voivodeship, Poland
Clinical Best Solutions Sp. z o.o., Sp. k🇵🇱 Lublin, Poland
Formed 2 Sp. z o.o.🇵🇱 Oświęcim, Poland
Mariodiab Clinic SRL🇷🇴 Brasov, Romania
SC Nutrilife SRL🇷🇴 Bucharest, Romania
S.C. Top Diabet Srl🇷🇴 Craiova, Dolj, Romania
S.C Milena Sante SRL🇷🇴 Galati, Romania
Clinica Korall S.R.L. Satu Mare🇷🇴 Satu Mare, Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara🇷🇴 Timișoara, Romania
MEDISPEKTRUM s.r.o.🌐 Bratislava, Slovakia
IN-DIA s.r.o.🌐 Lučenec, Slovakia
MEDI-DIA s.r.o.🌐 Sabinov, Slovakia
ARETEUS s.r.o.🌐 Trebišov, Slovakia
Chosun University Hospital_Endocrinology🇰🇷 Gwangju, South Korea
Asan Medical Center_Endocrinology🇰🇷 Seoul, South Korea
Korea University Guro Hospital_Endocrinology🇰🇷 Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology🇰🇷 Seoul, South Korea
Hospital Vall d'Hebron🇪🇸 Barcelona, Spain