A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes
Recruiting · NCT07668388 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 14 US states.
- Flourish Research - Birmingham, Alabama, United States
- Ark Clinical Research - Fountain Valley, California, United States
- Ark Clinical Research - Long Beach, California, United States
- Los Angeles Institute for Metabolic Research - Los Angeles, California, United States
- Catalina Research Institute, LLC - Montclair, California, United States
- Encore Medical Research LLC - Hollywood, Florida, United States
- South Broward Research LLC - Miramar, Florida, United States
- Encore Medical Research of Weston - Weston, Florida, United States
- Midwest Inst For Clin Res - Indianapolis, Indiana, United States
- Cotton O'Neil Diabetes & Endocrinology - Topeka, Kansas, United States
- MD Medical Research - Oxon Hill, Maryland, United States
- PharmQuest - Greensboro, North Carolina, United States
- KDCILM, LLC & Accellacare US, Inc. - Wilmington, North Carolina, United States
- Plains Clinical Research Center, LLC_Fargo - Fargo, North Dakota, United States
- Preferred Primary Care Physicians, Inc. - Uniontown, Pennsylvania, United States
- Monroe Biomedical Research, LLC - North Charleston, South Carolina, United States
- LifeDoc Health - Memphis, Tennessee, United States
- IMA Clinical Research - Austin, Texas, United States
- Private Practice - Dr. Laila A. Hassan - Houston, Texas, United States
- Radiance Clinical Research - Lampasas, Texas, United States
- Quality Research Inc - San Antonio, Texas, United States
- Tekton Research Inc - San Antonio, Texas, United States
- Consano Clin Res-Shavano Park - Shavano Park, Texas, United States
- Chrysalis Clinical Research - St. George, Utah, United States
- The Vancouver Clinic - Vancouver, Washington, United States
- Herz- und Diabeteszentrum NRW - Bad Oeynhausen - Bad Oeynhausen, Germany
- Hospital Vall d'Hebron - Barcelona, Spain
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR - Berlin, Germany
- Uniwersytecki Szpital Kliniczny w Bialymstoku - Bialystok, Poland
- DSP Bochum, Diabetes- und Stoffwechselpraxis - Bochum, Germany
- Mariodiab Clinic SRL - Brasov, Romania
- MEDISPEKTRUM s.r.o. - Bratislava, Slovakia
- SC Nutrilife SRL - Bucharest, Romania
- Szent Margit Rendelőintézet Nonprofit Kft. - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- PVN Kutató Kft. - Budapest, Hungary
- Studiengesellschaft Dres. Könemann/Steinmann GbR - Bünde, Germany
- Eap Osona Sud Alt Congost S.L.P - Centelles (Barcelona), Spain
- InnoDiab Forschung GmbH - Essen, Germany
- S.C Milena Sante SRL - Galati, Romania
- Chosun University Hospital_Endocrinology - Gwangju, South Korea
- Mesut Durmaz, Hof - Hof, Germany
- Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika Piwowar - Kielce, Poland
- Clinical Best Solutions Sp. z o.o., Sp. k - Lublin, Poland
- IN-DIA s.r.o. - Lučenec, Slovakia
- Hospital Universitario de la Princesa - Madrid, Spain
- CRS Clinical Research Mannheim GmbH (hVIVO Mannheim) - Mannheim, Germany
- Formed 2 Sp. z o.o. - Oświęcim, Poland
- Pécsi Tudományegyetem ÁOK - Pécs, Hungary
- MEDI-DIA s.r.o. - Sabinov, Slovakia
- H. Univ. Marqués de Valdecilla_Endocrinología - Santander, Spain
- Clinica Korall S.R.L. Satu Mare - Satu Mare, Romania
- Asan Medical Center_Endocrinology - Seoul, South Korea
- The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology - Seoul, South Korea
- Korea University Guro Hospital_Endocrinology - Seoul, South Korea
- H. Infanta Luisa_Endocrino y Obesidad - Seville, Spain
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara - Timișoara, Romania
- ARETEUS s.r.o. - Trebišov, Slovakia
- Equip D'assistencia Primaria Vic S.L.P. - Vic, Barcelona, Spain
- Versdias - Diabetologikum Amberg - Amberg, Bavaria, Germany
Showing 60 of 70 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →