NCT03987308

Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Based on the dual roles of glucagon-like peptide 1 (GLP-1) in regulating fasting blood glucose and postprandial blood glucose secretion, we adopted a combinational therapeutic model and will administer drug treatments during meals. Newly diagnosed type 2 diabetic patients will be administered continuous subcutaneous Beinaglutide injections using a pump device. The efficacy, safety and disease control after terminating the drug treatments will be compared to those of patients who receive CSII treatment. This is a national-level, multicenter, randomized, open study with parallel controls. The study consists of two phases: a 8-week treatment phase and a 12-week post-treatment follow-up period.

Conditions

• Type 2 Diabetic Patients
• T2DM (Type 2 Diabetes Mellitus)
• T2DM

Interventions

Type	Name	Description
DRUG	Beinaglutide	Beinaglutide (continuous subcutaneous infusion)
DRUG	Insulin aspart	Insulin aspart (CSII)

Timeline

• Start date: 2019-07-02
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2019-06-17
• Last updated: 2025-05-02

Locations

16 sites across 1 country: China