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
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
Treatments tested in this trial
- BGM0504
- BGM0504
- Semaglutide
Treatment groups
477 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov