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

NCT07282054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2025-12-15

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 T1DM.

Conditions

Interventions

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.

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
2022-04-13
Primary Completion
2025-01-23
Completion
2025-01-24

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 NCT07282054 on ClinicalTrials.gov