UBT251 for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether UBT251, a new treatment, is safe and effective for people with type 2 diabetes. Participants will be randomly assigned to receive either UBT251 (an experimental treatment), a placebo (a harmless pill resembling the real treatment), semaglutide (an existing diabetes medication), or a semaglutide placebo. The goal is to compare UBT251 with semaglutide in controlling diabetes. Suitable candidates have had type 2 diabetes for at least six months and are already taking stable doses of metformin, possibly with an SGLT2 inhibitor. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially effective diabetes treatments.
Will I have to stop taking my current medications?
You can continue taking metformin and possibly an SGLT2 inhibitor if you've been on a stable dose for at least 90 days before the trial. However, you must stop any other diabetes or obesity medications 90 days before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have found UBT251 to be generally safe and well-tolerated in people with type 2 diabetes. Most side effects were mild and related to digestion, such as an upset stomach or nausea. These results align with those seen in other treatments.
Although UBT251 is still under investigation and not yet approved for prescription, this research provides some reassurance about its safety. In contrast, semaglutide, also part of this trial, is already approved and widely used to treat type 2 diabetes, with a well-established safety record.12345Why do researchers think this study treatment might be promising for type 2 diabetes?
UBT251 is unique because it offers a new approach to managing Type 2 Diabetes with its once-weekly subcutaneous delivery. While standard treatments like metformin or insulin focus on regulating blood sugar levels through different mechanisms, UBT251 targets the condition with a potentially novel mechanism of action. Researchers are excited about UBT251 because it represents an innovative option that could enhance blood sugar control with less frequent dosing, possibly improving patient adherence and outcomes.
What evidence suggests that this trial's treatments could be effective for type 2 diabetes?
Research has shown that UBT251, which participants in this trial may receive, holds promise for treating type 2 diabetes. Studies have demonstrated that UBT251 can lower blood sugar levels by up to 2.16% and help participants lose an average of up to 19.7% of their body weight. This suggests that UBT251 could aid in managing both blood sugar and weight, crucial factors in controlling type 2 diabetes.
In this trial, another group of participants will receive semaglutide, a treatment already proven effective for type 2 diabetes. It lowers blood sugar and supports weight loss. Previous trials indicated that semaglutide helped people lose about 3 kg and significantly improved blood sugar levels over a few months. Both treatments show promise, but UBT251 is still under evaluation to fully understand its effects.678910Who Is on the Research Team?
Clinical Transparency dept. 2834
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for adults with type 2 diabetes. People who join should not have other major health problems that could interfere with the study, and must meet specific medical requirements set by the researchers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive once-weekly subcutaneous injections of UBT251, UBT251 placebo, semaglutide, or semaglutide placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- UBT251
Trial Overview
The study compares different doses of a new medicine called UBT251 to see how well it lowers blood sugar in people with type 2 diabetes. It also compares UBT251 to semaglutide (an approved diabetes drug) and placebos. Treatments are assigned randomly.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Participants will receive once weekly UBT251 subcutaneously.
Participants will receive once weekly semaglutide subcutaneously.
Participants will receive once weekly UBT251 placebo subcutaneously.
Participants will receive once weekly semaglutide placebo subcutaneously.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen
Citations
A Pharmacological and Clinical Overview of Oral Semaglutide ...
Treatment with oral semaglutide resulted in effective glycemic control, reductions in body weight, and decreases in systolic blood pressure.
2.
novomedlink.com
novomedlink.com/diabetes/products/treatments/rybelsus/efficacy-safety/A1C-and-weight-data.htmlRYBELSUS® (semaglutide) tablets 7 mg or 14 mg
In an open-label trial with a primary endpoint of mean change in A1C from baseline to 26 weeks, 822 adult patients with type 2 diabetes on metformin were ...
Semaglutide - StatPearls - NCBI Bookshelf - NIH
The Rybelsus® tablet brand demonstrates efficacy in improving glycemic control in patients with type 2 diabetes mellitus (T2DM). Ozempic® ...
Review Real-world Evidence on Oral Semaglutide for the ...
Overall, oral semaglutide demonstrated a significant BW reduction of around 3 kg over 6 to 12 months of follow-up when administered in routine clinical practice ...
FDA approves Novo Nordisk's oral semaglutide for ...
Oral semaglutide 14 mg demonstrated a statistically significant 14% relative reduction in risk of MACE at 4 years (2% absolute risk reduction ...
UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study
Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus
Novo Nordisk A/S: Triple agonist UBT251 showed a mean ...
UBT251 showed a mean. The safety and tolerability profile of UBT251 appeared consistent with what has been observed in other clinical trials … ...
8.
biopharminternational.com
biopharminternational.com/view/ubt251-phase-ii-data-intensify-triple-agonist-competition-in-diabetesUBT251 Phase II Data Intensify Triple-Agonist Competition ...
phase 2 data showing UBT251 delivers strong glycemic and weight reductions, Mean weight loss reached 9.8% from an 80.1-kg baseline,
UBT-251 - Drug Targets, Indications, Patents
Active Indication Diabetes Mellitus, Type 2ObesityMetabolic Dysfunction. The data Indication Highest Phase Country/Location Diabetes Mellitus, ...
10.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/novo-nordisk-partnered-drug-shows-19-7-weight-loss-in-phase-ii-trial/Novo Nordisk-partnered drug shows 19.7% weight loss in ...
UBT251 appeared to be safe and well-tolerated, with the most common adverse events being gastrointestinal, and the vast majority were mild to ...
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