NCT05834868

Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 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 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,040 (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 T2DM.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	THDB0206 Injection	Drug: THDB0206 Injection Injected subcutaneously three times a day. Dose was individually adjusted.
DRUG	Insulin Lispro Injection	Drug:Insulin Lispro Injection Injected subcutaneously three times a day. Dose was individually adjusted.

Timeline

• Start date: 2022-05-06
• Primary completion: 2024-12-10
• Completion: 2024-12-31
• First posted: 2023-04-28
• Last updated: 2025-12-22

Locations

1 site across 1 country: China