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

Purpose

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.

Condition

  • Diabetes Mellitus, Type 2

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
UBT251 		Participants will receive once weekly UBT251 subcutaneously.
  • Drug: UBT251
    UBT251 will be administered subcutaneously once-weekly.
  • Drug: UBT251 Placebo
    UBT251 placebo will be administered subcutaneously once-weekly.
Placebo Comparator
UBT251 Placebo 		Participants will receive once weekly UBT251 placebo subcutaneously.
  • Drug: UBT251 Placebo
    UBT251 placebo will be administered subcutaneously once-weekly.
Active Comparator
Semaglutide 		Participants will receive once weekly semaglutide subcutaneously.
  • Drug: Semaglutide
    Semaglutide will be administered subcutaneously once-weekly.
  • Drug: Semaglutide Placebo
    Semaglutide placebo will be administered subcutaneously once-weekly.
Placebo Comparator
Semaglutide Placebo 		Participants will receive once weekly semaglutide placebo subcutaneously.
  • Drug: Semaglutide Placebo
    Semaglutide placebo will be administered subcutaneously once-weekly.

Recruiting Locations

Flourish Research
Birmingham, Alabama 35205

Ark Clinical Research
Fountain Valley, California 92708

Ark Clinical Research
Long Beach, California 90815

Los Angeles Institute for Metabolic Research
Los Angeles, California 90015

Catalina Research Institute, LLC
Montclair, California 91763

Encore Medical Research LLC
Hollywood, Florida 33021

South Broward Research LLC
Miramar, Florida 33027

Encore Medical Research of Weston
Weston, Florida 33331

Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas 66606

MD Medical Research
Oxon Hill, Maryland 20745

KDCILM, LLC & Accellacare US, Inc.
Wilmington, North Carolina 28401

Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania 15401

Monroe Biomedical Research, LLC
North Charleston, South Carolina 29406

LifeDoc Health
Memphis, Tennessee 38115

IMA Clinical Research
Austin, Texas 78745

Private Practice - Dr. Laila A. Hassan
Houston, Texas 77089

Radiance Clinical Research
Lampasas, Texas 76550

Quality Research Inc
San Antonio, Texas 78209

Tekton Research Inc
San Antonio, Texas 78258

Consano Clin Res-Shavano Park
Shavano Park, Texas 78231

Chrysalis Clinical Research
St. George, Utah 84790

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com