Health TrialsbyHealthPanel

A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia

ConditionType 2 Diabetes (T2DM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBrightGene Bio-Medical Technology Co., Ltd.

About this trial

This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

○ Have been diagnosed with type 2 diabetes mellitus (T2DM);

Be on stable treatment with unchanged dose of metformin ≥1500 mg/day or <1500 mg/day but ≥1000 mg/day (the maximum tolerated dose) for at least 8 weeks prior to screening

Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;

Be of stable weight (± 5%) for at least 3 months before screening;

Disqualifiers

○ Previous diagnosis of type 1 diabetes, special type diabetes;

Have suffered the malignancy within the past 5 years (except cured basal cell carcinoma of the skin, cervical carcinoma in situ), or being evaluated for an underlying malignancy;

Have the acute or chronic pancreatitis;

Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist or metformin, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGM0504

    Drug

    Administered SC

  • BGM0504

    Drug

    Administered SC

  • Semaglutide

    Drug

    Administered SC

Treatment groups

477 Participants
are divided into 3 treatment groups
Group A: 5 mg BGM0504Experimental treatment 1 intervention
Group B: 10 mg BGM0504Experimental treatment 1 intervention
Group C: 1 mg SemaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Hemoglobin A1c (HbA1c)

Change from baseline in HbA1c after 24 weeks of treatment.

Time frame
Week 0 to Week 24

Secondary outcomes

1

Change From Baseline in Hemoglobin A1c (HbA1c)

Change from baseline in HbA1c after 12 weeks of treatment.

Time frame
Week 0 to Week 12
2

Change From Baseline in Body Weight

Change from baseline in body weight after 24 weeks of treatment.

Time frame
Week 0 to Week 24
3

Percentage of Participants With HbA1c Target Value of <7%

Percentage of Participants With HbA1c Target Value of \<7% after 24 weeks of treatment.

Time frame
Week 0 to Week 24
4

Percentage of Participants With HbA1c Target Value of <5.7%

Percentage of Participants With HbA1c Target Value of \<5.7%after 24 weeks of treatment.

Time frame
Week 0 to Week 24

Other outcomes

Sponsors and contacts

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

BrightGene Bio-Medical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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