Actively Recruiting
A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-10-28
477
Participants Needed
4
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus
- On stable metformin treatment (≥1500 mg/day or <1500 mg/day but ≥1000 mg/day) for at least 8 weeks before screening
- Body mass index (BMI) of 23 kg/m² or higher at screening
- Stable weight (±5%) for at least 3 months before screening
- HbA1c between 7.5% and 11.0% at screening
You will not qualify if you...
- Previous diagnosis of type 1 diabetes or special type diabetes
- History of cancer within the past 5 years, except cured basal cell carcinoma of the skin or cervical carcinoma in situ, or being evaluated for cancer
- Acute or chronic pancreatitis
- Allergic to three or more foods or medications, or allergic to GLP-1 agonist or metformin, or have severe allergic diseases such as asthma, urticaria, or eczematous dermatitis at screening
- Serious mental illness or speech impediment preventing full understanding of the study
- Suspected or confirmed history of alcohol or drug abuse
- History of two or more severe hypoglycemic episodes in the past year
- Other conditions that may affect assessment of study treatments, as determined by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
RS Universitas Indonesia
Depok, West Java, Indonesia
Actively Recruiting
2
RSUP Fatmawati
Jakarta, Indonesia
Actively Recruiting
3
RSUP Persahabatan
Jakarta, Indonesia
Actively Recruiting
4
RSUPN Dr. Cipto Mangunkusumo
Jakarta, Indonesia
Actively Recruiting
Research Team
T
Tahapary
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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