Health Trials

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

ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNovo Nordisk A/S

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

HbA1c of 7.0-10.5 percent (%) (53-91 millimoles per mole (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: UBT251Experimental treatment 1 intervention
Group B: UBT251 PlaceboPlacebo comparator 1 intervention
Group C: SemaglutideActive comparator 1 intervention
Group D: Semaglutide PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

UBT251: Change in glycated haemoglobin (HbA1c)

Measured as percentage (%)-point.

Time frame
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)

Secondary outcomes

1

UBT251: Relative change in body weight

Measured as %.

Time frame
From baseline (week 0) to week 40
2

UBT251: Change in body weight

Measured as kilogram (kg).

Time frame
From baseline (week 0) to week 40
3

UBT251 vs placebo: Change in HbA1c

Measured as %-point.

Time frame
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
4

Change in HbA1c

Measured as %-point.

Time frame
From baseline (week 0) to week 40

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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