Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGUBT251
UBT251 will be administered subcutaneously once-weekly.
DRUGUBT251 Placebo
UBT251 placebo will be administered subcutaneously once-weekly.
DRUGSemaglutide
Semaglutide will be administered subcutaneously once-weekly.
Semaglutide placebo will be administered subcutaneously once-weekly.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UBT251: Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40) | Measured as percentage (%)-point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UBT251: Relative change in body weight | From baseline (week 0) to week 40 | Measured as %. |
| UBT251: Change in body weight | From baseline (week 0) to week 40 | Measured as kilogram (kg). |
| UBT251 vs placebo: Change in HbA1c | From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40) | Measured as %-point. |
| Change in HbA1c | From baseline (week 0) to week 40 | Measured as %-point. |
| Change in homeostasis model assessment of insulin resistance (HOMA2-IR) | From baseline (week 0) to week 40 | Measured as ratio to baseline. |
| Change in homeostasis model assessment of beta-cell function (HOMA2-B) | From baseline (week 0) to week 40 | Measured as ratio to baseline. |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40) | Measured as millimoles per litre (mmol/L). |
| CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 milligrams per deciliter (mg/dL)) | From baseline (week -2 to week 0) to week 14- 16, week 26-28 and week 38-40, respectively | Measured as %-points. |
| UBT251 vs placebo: Relative change in body weight | From baseline (week 0) to week 40 | Measured as %. |
| UBT251 vs placebo: Change in body weight | From baseline (week 0) to week 40 | Measured as kg. |
| Change in body mass index (BMI) | From baseline (week 0) to week 40 | Measured as Kilograms per square meter (kg/m\^2). |
| Change in waist circumference | From baseline (week 0) to week 40 | Measured as centimeter (cm). |
| Change in waist-to-height ratio (WHtR) | From baseline (week 0) to week 40 | — |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to week 40 | Measured as millimetres of mercury (mmHg). |
| Change in diastolic blood pressure (DBP) | From baseline (week 0) to week 40 | Measured as mmHg. |
| Change in pulse rate | From baseline (week 0) to week 40 | Measured in beats/min. |
| Change in high sensitivity C-Reactive Protein (hsCRP) | From baseline (week 0) to week 40 | Measured as ratio to baseline. |
| Change in total cholesterol | From baseline (week 0) to week 40 | Measured as ratio to baseline. |
| Change in high-density lipoprotein (HDL) cholesterol | From baseline (week 0) to week 40 | Measured as ratio to baseline. |
| Change in low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to week 40 | Measured as ratio to baseline. |
| Change in triglycerides | From baseline (week 0) to week 40 | Measured as ratio to baseline. |
| Change in urine albumin creatinine ratio (UACR) | From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40) | Measured as ratio to baseline. |
| Change in eGFR (creatinine-cystatin C-based CKD-EPI 2021) | From baseline (week 0) to week 40 | Measured in milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2). |
| Number of treatment-emergent adverse events (TEAEs) | From baseline (week 0) to week 46 | Measured as number of events. |
Countries
Australia, Germany, Hungary, Poland, Romania, Slovakia, South Korea, Spain, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed