Actively Recruiting
A Study of BGM0504 in Participants with Type 2 Diabetes
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-02-07
537
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
B
BrightGene Bio-Medical Technology Co., Ltd.
Lead Sponsor
B
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes
CONDITIONS
Official Title
A Study of BGM0504 in Participants with Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus (T2DM)
- Used stable-dose metformin (≥1500 mg/day) or maximum tolerated dose (≥1000 mg but <1500 mg daily) for 8 weeks before screening
- On metformin treatment dose <1500 mg/day at screening without reaching maximum tolerated dose
- On stable metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose) for at least 8 weeks before starting the study
- Have a 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%
You will not qualify if you...
- Previous diagnosis of type 1 diabetes or special type diabetes
- Malignant tumors within 5 years before screening or latent/clinical malignant tumors (except certain skin, cervical, prostate, or thyroid cancers without recurrence after surgery)
- History of chronic or acute pancreatitis before study entry
- Known allergies to 3 or more foods or drugs, allergy to GLP-1 receptor agonists, or severe allergic diseases at screening
- Mentally incapacitated or speech-impaired
- Suspected or confirmed history of alcohol or drug abuse
- Pregnant or lactating women
- Any other condition deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
L
Linong Ji,MD, chief physician, Peking University People's Hospital
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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