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

NCT05834868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2025-12-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Tonghua Dongbao Pharmaceutical Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-06
Primary Completion
2024-12-10
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05834868 on ClinicalTrials.gov