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Comparing the Safety and Effectiveness of Continuous Beinaglutide Pump Injection Versus Continuous Insulin Pump Infusion in Adults Newly Diagnosed with Type 2 Diabetes
Led by Beijing Hospital · Updated on 2025-05-02
115
Participants Needed
16
Research Sites
13 weeks
Total Duration
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
Research Team
L
Lixin Guo, M.D.,Ph.D.
D
Dongni Yu, M.D.
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