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

NCT07282054 ↗

Phase 3 Completed 550 enrolled Tonghua Dongbao Pharmaceutical Co.,Ltd

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2022-04-13
Primary completion: 2025-01-23
Completion: 2025-01-24

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Insulin Lispro	Protein / enzyme biologic	—	Subcutaneous
Subject	THDB0206	Unknown	—	Subcutaneous
Background	insulin glargine	Protein / enzyme biologic	—	Subcutaneous

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

Summary

Timeline

Drugs

Indications