Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin ± Sulfonylurea/SGLT2 Inhibitor Therapy (UNIGUIDE-2)

What Was Tested

The trial (phase 3) is built around Semaglutide.

This study is a multicenter, randomized, open-label, parallel-group, semaglutide injection-controlled clinical trial.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

956 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged 18 to 75 years (inclusive) at the time of signing informed consent, with no restriction on gender;. Participants who have been fully informed about the study and have voluntarily signed written informed consent.

The full record lists 6 inclusion and 45 exclusion criteria; among the exclusions: known history of hypersensitivity to the investigational medicinal product or its excipients or other similar active drugs;; treatment with any of the following medications within 3 months prior to screening:; other antidiabetic medications except background therapy (short-term insulin use ≤14 days for acute conditions is allowed, e.g., perioperative period or hospitalization);.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2026-09-07 with completion listed for 2028-02-29.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (time frame: Week 40).

It also tracked 7 secondary outcomes, for example Body weight, HbA1c, HbA1c, HbA1c, Body weight and HbA1c.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 956 people.

With 956 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.