NCT05677334

Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

Study on the Efficacy and Safety of Henagliflozin Combined with Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring System

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: First Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The Multi-center, randomized, controlled clinical trial investigate the efficacy and safety of Henagliflozin combined with continuous subcutaneous insulin infusion in newly diagnosed type 2 diabetes

Detailed description

The therapeutic mechanisms of Sglt2i and continuous subcutaneous insulin infusion (CSII) are complementary. We hypothesized that for newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia, combination treatment with Henagliflozin and CSII could achieve glycaemic control in a shorter time, shorten the duration of hospitalization and reduce the total insulin dosage. We also hope to investigate the safety of sglt2i in combination with CSII in T2DM based on continuous glucose monitoring system.

Conditions

• Type2diabetes

Interventions

Type	Name	Description
DRUG	Henagliflozin	Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion
DEVICE	Continuous Subcutaneous Insulin Infusion	Continuous Subcutaneous Insulin Infusion therapy alone

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2023-01-10
• Last updated: 2025-03-12

Locations

1 site across 1 country: China