Status:
RECRUITING
A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Lead Sponsor:
BrightGene Bio-Medical Technology Co., Ltd.
Collaborating Sponsors:
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic co...
Eligibility Criteria
Inclusion Criteria:
-
☑ Have been diagnosed with type 2 diabetes mellitus (T2DM);
- Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
- Be of stable weight (± 5%) for at least 3 months before screening;
- Have HbA1c between ≥7.5% and ≤11.0%;
- Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.
Exclusion Criteria:
-
■ Previous diagnosis of type 1 diabetes, special type diabetes ;
- There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
- Have had chronic or acute pancreatitis any time prior to study entry;
- Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
- Mentally incapacitated or speech-impaired;
- Suspected or confirmed history of alcohol or drug abuse;
- Pregnant or lactating woman;
- The investigator considers that there are any other conditions that make it inappropriate to participate in this study.
Key Trial Info
Start Date :
December 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 25 2026
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT06716203
Start Date
December 2 2024
End Date
August 25 2026
Last Update
February 7 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044