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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

NCT07668388

RecruitingPhase 2

Sponsor: Novo Nordisk A/S

Conditions: Diabetes Mellitus, Type 2

Interventions: UBT251, UBT251 Placebo, Semaglutide, Semaglutide Placebo

Countries: United States, Australia, Germany, Hungary, Poland, Romania, Slovakia, South Korea

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (70)

Birmingham, Alabama, United States
Fountain Valley, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Montclair, California, United States
Hollywood, Florida, United States
Miramar, Florida, United States
Weston, Florida, United States
Indianapolis, Indiana, United States
Topeka, Kansas, United States
Oxon Hill, Maryland, United States
Greensboro, North Carolina, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Uniontown, Pennsylvania, United States
North Charleston, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Lampasas, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Shavano Park, Texas, United States
St. George, Utah, United States
Vancouver, Washington, United States
Castle Hill, New South Wales, Australia
Charlestown, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Sydney, New South Wales, Australia
Adelaide, South Australia, Australia
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