A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes
Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well different doses of UBT251 lower blood sugar and how safe it is for adults with type 2 diabetes. People will get UBT251, semaglutide, or a placebo (a treatment with no active medicine), chosen by chance. UBT251 is not yet available for doctors to prescribe, but semaglutide is.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- People of all gender identities may join.
- Be 18 to 75 years old when signing the study consent form.
- Have been diagnosed with type 2 diabetes at least 180 days before screening.
- Take metformin, with or without an SGLT2 inhibitor (another diabetes medicine). Daily doses must be unchanged for at least 90 days before screening and judged by the study doctor to work well or be the highest dose you can tolerate.
- Have an HbA1c of 7.0% to 10.5% at screening. This blood test measures your average blood sugar.
- Have a body mass index (BMI) of 25 to 50 at screening. BMI is a measure based on height and weight.
Who can't join
- Used other medicines or alternative remedies for diabetes or obesity within 90 days before screening. Insulin used for up to 14 days in a row, or previously used for diabetes during pregnancy, is allowed.
- Have diabetes-related eye damage that is not controlled and may be unstable. An eye exam is needed to check this.
- Have trouble noticing when your blood sugar is too low, as checked by the study doctor using a questionnaire.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (25)
AL
- Flourish Research · Birmingham, AL 35205More trials in Birmingham
CA
- Ark Clinical Research · Fountain Valley, CA 92708More trials in Fountain Valley
- Ark Clinical Research · Long Beach, CA 90815More trials in Long Beach
- Los Angeles Institute for Metabolic Research · Los Angeles, CA 90015More trials in Los Angeles
- Catalina Research Institute, LLC · Montclair, CA 91763More trials in Montclair
FL
- Encore Medical Research LLC · Hollywood, FL 33024More trials in Hollywood
- South Broward Research LLC · Miramar, FL 33027More trials in Miramar
- Encore Medical Research of Weston · Weston, FL 33331More trials in Weston
IN
- Midwest Inst For Clin Res · Indianapolis, IN 46260More trials in Indianapolis
KS
- Cotton O'Neil Diabetes & Endocrinology · Topeka, KS 66606More trials in Topeka
MD
- MD Medical Research · Oxon Hill, MD 20745More trials in Oxon Hill
NC
- PharmQuest · Greensboro, NC 27408More trials in Greensboro
- KDCILM, LLC & Accellacare US, Inc. · Wilmington, NC 28401More trials in Wilmington
ND
- Plains Clinical Research Center, LLC_Fargo · Fargo, ND 58104More trials in Fargo
PA
- Preferred Primary Care Physicians, Inc. · Uniontown, PA 15401More trials in Uniontown
SC
- Monroe Biomedical Research, LLC · North Charleston, SC 29406More trials in North Charleston
TN
- LifeDoc Health · Memphis, TN 38115More trials in Memphis
TX
- IMA Clinical Research · Austin, TX 78745More trials in Austin
- Private Practice - Dr. Laila A. Hassan · Houston, TX 77089More trials in Houston
- Radiance Clinical Research · Lampasas, TX 76550More trials in Lampasas
- Quality Research Inc · San Antonio, TX 78209More trials in San Antonio
- Tekton Research Inc · San Antonio, TX 78258More trials in San Antonio
- Consano Clin Res-Shavano Park · Shavano Park, TX 78231More trials in Shavano Park
UT
- Chrysalis Clinical Research · St. George, UT 84790More trials in St. George
WA
- The Vancouver Clinic · Vancouver, WA 98664More trials in Vancouver