Status:
COMPLETED
A Study of BGM0504 in Chinese Patients With Type 2 Diabetes
Lead Sponsor:
BrightGene Bio-Medical Technology Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of BGM0504 in Chinese patients with Type 2 Diabetes.
Eligibility Criteria
Inclusion
- Have been diagnosed with type 2 diabetes mellitus (T2DM);
- Glycosylated hemoglobin (HbA1c) at screening/baseline: 7.0% ≤ HbA1c ≤ 10%;
- Body Mass Index (BMI): 19.5 kg/m2 ≤ BMI ≤ 35.0 kg/m2;
- Fasting blood glucose (FPG) at screening/baseline: FPG ≤ 13.3 mmoL/L
Exclusion
- Diagnosed with non-type 2 diabetes mellitus;
- Grade 3 hypoglycemia within 6 months prior to screening;
- Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose at screening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy;
- Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening;
- Patients with a previous history or clinical evidence of acute or chronic pancreatitis;
- Malignant tumor confirmed within 5 years prior to screening (except cured carcinoma in situ) or potential malignant tumor assessed at screening;
- Patients with severe mental illness or language disorder at screening, unwilling or unable to fully understand and cooperate;
- Female subjects during pregnancy or lactation.
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2024
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT06974825
Start Date
August 30 2023
End Date
August 13 2024
Last Update
May 16 2025
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China