Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for
This trial is looking for people with type 2 diabetes to test a new medicine called UBT251. Participants will receive either UBT251, a placebo, or another medication called semaglutide, chosen at random.
Are You a Good Fit for This Trial?
Must be takingMetformin
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with type 2 diabetes for at least 180 days.
I have been using stable doses of metformin or SGLT2 inhibitors for at least 90 days.
My HbA1c level is between 7.0 and 10.5 percent.
My body mass index is between 25.0 and 50.0.
You may not be able to join if
I have used other diabetes or obesity medications in the last 90 days.
I have uncontrolled eye issues related to diabetes.
I have hypoglycemic unawareness.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 availab…
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 Locations
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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…
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.
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