NCT07282054

Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes

A Phase 3, Randomized, Open-Label, Multicenter, Active-controlled Trial Comparing Efficacy and Safety of THDB0206 Injection With Insulin Lispro Injection Combined With Insulin Glargine Injection U-100 in Chinese Participants With Type 1 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a 26-week randomized, open-label, multicenter, active-controlled parallel group trial. The purpose of this study is to compare efficacy and safety of THDB0206 injection with insulin lispro injection combined with insulin glargine injection U-100 in Chinese participants with T1DM.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	THDB0206	Subcutaneous THDB0206 three times daily, with individualized dose adjustment.
DRUG	Insulin Lispro	Subcutaneous insulin lispro three times daily, with individualized dose adjustment.
DRUG	Insulin Glargine	Subcutaneous insulin glargine once daily, with individualized dose adjustment.

Timeline

• Start date: 2022-04-13
• Primary completion: 2025-01-23
• Completion: 2025-01-24
• First posted: 2025-12-15
• Last updated: 2025-12-15

Locations

1 site across 1 country: China