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

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe United Bio-Technology (Hengqin) Co., Ltd.

About this trial

This study is a multicenter, randomized, open-label, parallel-group, semaglutide injection-controlled clinical trial. It aims to evaluate the non-inferiority of UBT251 Injection in glycemic control compared with Semaglutide Injection after 40 weeks of continuous administration in study participants with Type 2 Diabetes Mellitus (T2DM) and inadequate glycemic control on oral antidiabetic medications.A total of 956 participants are planned to be enrolled, including the UBT251 Injection 2 mg group, 4 mg group, 6 mg group, and Semaglutide group，with an approximate study duration of 58 weeks per participant.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75 years (inclusive) at the time of signing informed consent, with no restriction on gender;

Diagnosed with Type 2 Diabetes Mellitus (T2DM) according to the 2019 World Health Organization (WHO) criteria (Appendix 1), with glycated hemoglobin (HbA1c) ≥7.5% and ≤11.0%;

Body mass index (BMI) ≥23.0 kg/m² at screening, with stable body weight for 3 months prior to screening (change <5%, based on participant's report);

Participants (including their partners) with no plan for pregnancy from screening until 6 months after completion of the study, willing to use contraceptive measures, and with no plan to donate sperm or ova within 6 months after study completion;

Disqualifiers

Known history of hypersensitivity to the investigational medicinal product or its excipients or other similar active drugs;

Other antidiabetic medications except background therapy (short-term insulin use ≤14 days for acute conditions is allowed, e.g., perioperative period or hospitalization);

Medications that may affect glucose metabolism, such as systemic glucocorticoids, growth hormone, etc. (excluded if cumulative use <7 days and the end of treatment is >7 half-lives prior to the first day of screening);

Weight-loss medications (including but not limited to orlistat, semaglutide, or other similar prescription or over-the-counter drugs for weight loss).

Trial design

Design model

Parallel

Treatments tested in this trial

  • UBT251 Injection 2.0 mg group

    Drug

    UBT251 Injection subcutaneously once weekly

  • UBT251 Injection 4.0 mg group

    Drug

    UBT251 Injection subcutaneously once weekly

  • UBT251 Injection 6.0 mg group

    Drug

    UBT251 Injection subcutaneously once weekly

  • Semaglutide Injection

    Drug

    Semaglutide Injection subcutaneously once weekly

Treatment groups

956 Participants
are divided into 4 treatment groups
Group A: UBT251 Injection 2.0mg groupExperimental treatment 1 intervention
Group B: UBT251 Injection 4.0mg groupExperimental treatment 1 intervention
Group C: UBT251 Injection 6.0mg groupExperimental treatment 1 intervention
Group D: Semaglutide Injection 1mg groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Change in HbA1c from Baseline

Time frame
Week 40

Secondary outcomes

1

Body weight

Percent change in body weight from baseline

Time frame
Week 40
2

HbA1c

Proportion of participants with HbA1c ≤6.5% and body weight reduction ≥10% from baseline

Time frame
Week 40
3

HbA1c

Proportion of participants with HbA1c ≤6.5%

Time frame
Week 40
4

HbA1c

Change in HbA1c from baseline

Time frame
Week 24, Week 32, Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The United Bio-Technology (Hengqin) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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