A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes
Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study
3 other identifiers
interventional
300
9 countries
69
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Jun 2026
Typical duration for phase_2 diabetes-mellitus-type-2
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2026
CompletedStudy Start
First participant enrolled
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2027
July 14, 2026
July 1, 2026
1.3 years
June 19, 2026
July 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
UBT251: Change in glycated haemoglobin (HbA1c)
Measured as percentage (%)-point.
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Secondary Outcomes (24)
UBT251: Relative change in body weight
From baseline (week 0) to week 40
UBT251: Change in body weight
From baseline (week 0) to week 40
UBT251 vs placebo: Change in HbA1c
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Change in HbA1c
From baseline (week 0) to week 40
Change in homeostasis model assessment of insulin resistance (HOMA2-IR)
From baseline (week 0) to week 40
- +19 more secondary outcomes
Study Arms (4)
UBT251
EXPERIMENTALParticipants will receive once weekly UBT251 subcutaneously.
UBT251 Placebo
PLACEBO COMPARATORParticipants will receive once weekly UBT251 placebo subcutaneously.
Semaglutide
ACTIVE COMPARATORParticipants will receive once weekly semaglutide subcutaneously.
Semaglutide Placebo
PLACEBO COMPARATORParticipants will receive once weekly semaglutide placebo subcutaneously.
Interventions
Semaglutide placebo will be administered subcutaneously once-weekly.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (69)
Flourish Research
Birmingham, Alabama, 35205, United States
Ark Clinical Research
Fountain Valley, California, 92708, United States
Ark Clinical Research
Long Beach, California, 90815, United States
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Encore Medical Research LLC
Hollywood, Florida, 33021, United States
South Broward Research LLC
Miramar, Florida, 33027, United States
Encore Medical Research of Weston
Weston, Florida, 33331, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
KDCILM, LLC & Accellacare US, Inc.
Wilmington, North Carolina, 28401, United States
Plains Clinical Research Center, LLC_Fargo
Fargo, North Dakota, 58104, United States
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, 15401, United States
Monroe Biomedical Research, LLC
North Charleston, South Carolina, 29406, United States
LifeDoc Health
Memphis, Tennessee, 38115, United States
IMA Clinical Research
Austin, Texas, 78745, United States
Private Practice - Dr. Laila A. Hassan
Houston, Texas, 77089, United States
Radiance Clinical Research
Lampasas, Texas, 76550, United States
Quality Research Inc
San Antonio, Texas, 78209, United States
Tekton Research Inc
San Antonio, Texas, 78258, United States
Consano Clin Res-Shavano Park
Shavano Park, Texas, 78231, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
The Vancouver Clinic
Vancouver, Washington, 98664, United States
Castle Hill Medical Centre
Castle Hill, New South Wales, 2154, Australia
Hunter Medical Research Institute - Endocrinology and Diabetes
New Lambton Heights, New South Wales, 2305, Australia
Roger Chih Yu Chen
Sydney, New South Wales, 2148, Australia
Royal Adelaide Hospital - Cardiology Department
Adelaide, South Australia, 5000, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004, Australia
Versdias - Diabetologikum Amberg
Amberg, Bavaria, 92224, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
Berlin, 13597, Germany
DSP Bochum, Diabetes- und Stoffwechselpraxis
Bochum, 44869, Germany
Studiengesellschaft Dres. Könemann/Steinmann GbR
Bünde, 32257, Germany
InnoDiab Forschung GmbH
Essen, 45136, Germany
Mesut Durmaz, Hof
Hof, 95030, Germany
CRS Clinical Research Mannheim GmbH (hVIVO Mannheim)
Mannheim, 68167, Germany
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, 6725, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
Budapest, 1032, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
PVN Kutató Kft.
Budapest, 1102, Hungary
Pécsi Tudományegyetem ÁOK
Pécs, 7624, Hungary
1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
Lublin, Lublin Voivodeship, 20-049, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, 15-879, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika Piwowar
Kielce, 25-355, Poland
Clinical Best Solutions Sp. z o.o., Sp. k
Lublin, 20-011, Poland
Formed 2 Sp. z o.o.
Oświęcim, 32-600, Poland
S.C. Top Diabet Srl
Craiova, Dolj, 200515, Romania
Mariodiab Clinic SRL
Brasov, 500101, Romania
SC Nutrilife SRL
Bucharest, 013764, Romania
S.C Milena Sante SRL
Galati, 800001, Romania
Clinica Korall S.R.L. Satu Mare
Satu Mare, 440055, Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, 300723, Romania
MEDISPEKTRUM s.r.o.
Bratislava, 851 01, Slovakia
IN-DIA s.r.o.
Lučenec, 984 01, Slovakia
MEDI-DIA s.r.o.
Sabinov, 08301, Slovakia
ARETEUS s.r.o.
Trebišov, 075 01, Slovakia
Chosun University Hospital_Endocrinology
Gwangju, 61453, South Korea
Asan Medical Center_Endocrinology
Seoul, 05505, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
Seoul, 06591, South Korea
Korea University Guro Hospital_Endocrinology
Seoul, 08308, South Korea
Equip D'assistencia Primaria Vic S.L.P.
Vic, Barcelona, 08500, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Eap Osona Sud Alt Congost S.L.P
Centelles (Barcelona), 08540, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
H. Infanta Luisa_Endocrino y Obesidad
Seville, 41010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency dept. 2834
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2026
First Posted
June 25, 2026
Study Start
June 22, 2026
Primary Completion (Estimated)
October 4, 2027
Study Completion (Estimated)
November 15, 2027
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.