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Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Treatment of Patients With Newly Diagnosed Type 2 Diabetes: a Multicenter, Randomized Open Trial Study With Parallel Controls
Led by Beijing Hospital · Updated on 2025-05-02
115
Participants Needed
16
Research Sites
13 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and disease control after treatment between continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adults newly diagnosed with type 2 diabetes. This national-level, multicenter, randomized, open study aims to compare these two treatments based on their effects on blood glucose regulation and overall disease management over a short-term period. The trial includes two groups: one receiving an 8-week continuous subcutaneous Beinaglutide infusion using a pump device administered during meals, and the other receiving an 8-week continuous subcutaneous insulin aspart infusion (CSII). Following the treatment phase, participants enter a 12-week post-treatment follow-up to assess ongoing disease control and safety. Participants will undergo various assessments including blood glucose levels, HbA1c, weight, waist circumference, insulin and C-peptide levels, lipid profiles, blood pressure, and heart rate at baseline, after 8 weeks of treatment, and at week 20. Safety and treatment adherence will be monitored throughout the study. The primary measure is the proportion of participants achieving specific HbA1c levels without weight gain or hypoglycemia at 8 weeks. The total study duration for each participant is 20 weeks, including treatment and follow-up.
CONDITIONS
Brief 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 18 to 70 years (inclusive) at enrollment, regardless of gender.
- Voluntary signing of the informed consent form.
- Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration of 1 year or less.
- HbA1c between 7.5% and 10.0%.
- Body mass index (BMI) between 24 kg/m² and 42 kg/m².
- No prior antidiabetic medications or oral antidiabetic medications used for less than 3 months and discontinued for more than 1 month before enrollment.
- Subjects with reproductive potential agree to use effective contraception during the study and for 1 month after completion.
You will not qualify if you...
- Patients with type 1 diabetes or other types of diabetes.
- History of obstructive intestinal diseases or related complications.
- History of pancreatitis.
- Family history of medullary thyroid carcinoma.
- History of malignant tumors.
- Liver enzymes (ALT, AST) more than 3 times the upper normal limit or total bilirubin more than 2 times the upper normal limit.
- Moderate to severe kidney problems (eGFR less than 60 ml/min/1.73m²).
- Triglycerides level 5.0 mmol/L or higher.
- Multiple endocrine neoplasia type 2 (MEN 2).
- Participation in any pre-marketing drug study within 3 months.
- Use or expected use of systemic corticosteroids, immunosuppressants, or cytotoxic drugs during the study.
- History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months before screening.
- Blood pressure above 160/100 mmHg (treated or untreated).
- Recent cardiovascular events or heart failure within 3 months before screening.
- Allergy to binaclotide, insulin, or any component of study drugs.
- Presence of other severe diseases interfering with the study.
- Pregnant or breastfeeding women.
- Poor compliance or inability to complete the study.
- Inability or unwillingness to use continuous pump infusion.
- Any other factors deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either continuous subcutaneous Beinaglutide infusion or continuous subcutaneous insulin infusion (CSII) for 8 weeks to manage newly diagnosed type 2 diabetes.
Visits occur regularly during the 8-week treatment period
Duration - 12 weeks
Participants are monitored for 12 weeks after treatment ends to assess ongoing efficacy and safety.
Visits occur periodically during the 12-week follow-up period
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.
D
Dongni Yu, M.D.
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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