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Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
Led by Beijing Hospital · Updated on 2025-05-02
115
Participants Needed
16
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.
CONDITIONS
Official Title
Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years at enrollment
- Voluntary signing of informed consent
- Newly diagnosed type 2 diabetes mellitus within 1 year, diagnosed by WHO 1999 criteria
- HbA1c between 7.5% and 10.0%
- Body mass index (BMI) between 24 and 42 kg/m²
- No prior antidiabetic medication use or less than 3 months of oral antidiabetic medication, discontinued for more than 1 month
- Agreement to use effective contraception during the study and for 1 month after if of reproductive potential
You will not qualify if you...
- Diagnosis of type 1 diabetes or other forms of diabetes
- History of obstructive intestinal diseases or related complications including Crohn's disease or ulcerative colitis
- History of pancreatitis
- Family history of medullary thyroid carcinoma
- History of malignant tumors
- Elevated liver enzymes (ALT, AST) more than 3 times normal or total bilirubin more than twice normal
- Moderate to severe kidney insufficiency (eGFR less than 60 ml/min/1.73m²)
- Triglyceride levels greater than or equal to 5.0 mmol/L
- Multiple endocrine neoplasia type 2 (MEN 2)
- Participation in any drug study within the past 3 months
- Use or planned use of systemic corticosteroids, immunosuppressants, or cytotoxic drugs during the study
- History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months prior to screening
- High blood pressure: systolic ≥160 mmHg and/or diastolic ≥100 mmHg
- Recent cardiovascular events within 3 months prior to screening including heart attack, severe heart failure, or stroke
- Allergy to Beinaglutide, insulin, or any study drug components
- Other severe diseases that could interfere with the study
- Pregnant or breastfeeding women
- Poor compliance or inability to complete the study
- Inability or unwillingness to use continuous pump infusion due to allergies, psychological reasons, lack of knowledge, or severe mental disorders
- Any other factors deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Pinggu District Hospital
Beijing, Beijing Municipality, China, 000
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2
Capital Medical University Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
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3
Emergency General Hospital
Beijing, Beijing Municipality, China
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4
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
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5
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China, 000
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6
Harbin Medical University Second Hospital
Harbin, Heilongjiang, China
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7
Southeast University Zhongda Hospital
Nanjing, Jiangsu, China, 000
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8
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu, China
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9
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
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10
Jilin University Second Hospital
Changchun, Jilin, China
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11
Xi'an Jiaotong University Second Hospital
Xi'an, Shaanxi, China, 000
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12
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, China, 000
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13
Peking University Binhai Hospital
Tianjin, Tianjin Municipality, China
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14
First Hospital of Peking University
Beijing, China, 100034
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15
Heilongjiang provincial hospital
Harbin, China, 150030
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16
Henan People's Hospital
Zhengzhou, China, 450003
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Research Team
L
Lixin Guo, M.D.，Ph.D.
CONTACT
D
Dongni Yu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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