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Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone（UNIGUIDE-1）

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 multicenter, randomized, double-Blind, parallel-group, placebo-controlled phase III trial is to evaluate the efficacy and safety of UBT251 Injection in patients with Type 2 Diabetes Mellitus with inadequate glycemic control on diet and exercise alone

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of gender;

Diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months in accordance with the 2019 World Health Organization (WHO) criteria;

Managed solely through diet and exercise intervention (without the use of any glucose-lowering medications) for at least 3 months prior to screening;

Glycated hemoglobin (HbA1c) level ≥7.5% and ≤10.5% at screening;

Disqualifiers

Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;

Diagnosis of other types of diabetes: such as type 1 diabetes mellitus (T1DM), other specific types of diabetes (e.g., genetic defects in beta-cell function, genetic defects in insulin action, diseases of the exocrine pancreas, etc.);

History of acute or chronic pancreatitis, or pancreatic surgery;

History of symptomatic gallbladder disease within 1 year before screening (excluding trial participants who have undergone cholecystectomy [completed at least 3 months before screening] without long-term complications), or abdominal ultrasound at screening indicating large gallstones (diameter ≥2 cm), gallbladder polyps (diameter ≥1 cm), or other gallbladder lesions that the study physician determines may affect trial participant safety;

Trial design

Design model

Parallel

Treatments tested in this trial

  • UBT251 Injection 2.0 mg

    Drug

    UBT251 Injection subcutaneously once weekly

  • UBT251 Injection 4.0 mg

    Drug

    UBT251 Injection subcutaneously once weekly

  • UBT251 Injection 6.0 mg

    Drug

    UBT251 Injection subcutaneously once weekly

  • UBT251 Injection Placebo 2.0 mg

    Drug

    UBT251 Injection placebo subcutaneously once weekly

  • UBT251 Injection Placebo 4.0 mg

    Drug

    UBT251 Injection placebo subcutaneously once weekly

  • UBT251 Injection Placebo 6.0 mg

    Drug

    UBT251 Injection placebo subcutaneously once weekly

Treatment groups

360 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: UBT251 Injection 2.0 mgExperimental treatment 1 intervention
Group B: UBT251 Injection 4.0 mgExperimental treatment 1 intervention
Group C: UBT251 Injection 6.0 mgExperimental treatment 1 intervention
Group D: UBT251 Injection Placebo 2.0 mgPlacebo comparator 1 intervention
Group E: UBT251 Injection Placebo 4.0 mgPlacebo comparator 1 intervention
Group F: UBT251 Injection Placebo 6.0 mgPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Change in HbA1c from Baseline

Time frame
Week 40

Secondary outcomes

1

Proportion of participants with HbA1c <7.0%

Proportion of participants with HbA1c \<7.0% from baseline

Time frame
Week 40
2

Body weight

Percent change in body weight from baseline

Time frame
Week 40
3

Proportion of participants with body weight reduction ≥5%

Proportion of participants with body weight reduction ≥5% from baseline

Time frame
Week 40
4

Proportion of trial participants with HbA1c <7.0% and body weight reduction ≥5%

Proportion of trial participants with HbA1c \<7.0% and body weight reduction ≥5% from baseline

Time frame
Week 40

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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