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Compares treatment options for Diabetes Mellitus, Type 2
Official title A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes
ClinicalTrials.gov ID: NCT07668388
What this study is testing
What is UBT251?
UBT251 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for diabetes mellitus, type 2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- HbA1c of 7.0-10.5 percent (%) (53-91 millimoles per mole (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
You likely can't join if
- Treatment with any medication (prescription or over-the counter) or alternative remedies for the indication of diabetes or obesity other than stated...
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening...
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire, question 8.
See the full eligibility 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...
- 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.
- 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...
- 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...
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire, question 8.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fountain Valley, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Montclair, California, United States
- Hollywood, Florida, United States
- Miramar, Florida, United States
- Weston, Florida, United States
- Indianapolis, Indiana, United States
- Topeka, Kansas, United States
- Oxon Hill, Maryland, United States
- Greensboro, North Carolina, United States
- Wilmington, North Carolina, United States
- Fargo, North Dakota, United States
- Uniontown, Pennsylvania, United States
- North Charleston, South Carolina, United States
- Memphis, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Lampasas, Texas, United States
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Fountain Valley, California, United States; Long Beach, California, United States; Los Angeles, California, United States; Montclair, California, United States; Hollywood, Florida, United States and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.