Phase 3Completed
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
- Sponsor
- Tonghua Dongbao Pharmaceutical Co.,Ltd (Industry)
- Enrolment
- 550 enrolled
- Conditions
- Type 1 Diabetes
- Interventions
- THDB0206; Insulin Lispro; Insulin Glargine
- Ages
- adults, older adults
- Registry
- NCT07282054
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from Baseline in HbA1c at Week 26
History
Registered
Study completion
Primary completion
Started