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

December 15, 2025 updated by: Tonghua Dongbao Pharmaceutical Co.,Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1040

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body mass index: 18.0 kg/m^2~35.0 kg/m^2 (both inclusive) at the time of screening.
  • HbA1c: 7.0%~10.0% (both inclusive) at the time of screening.
  • Diagnosed with T2DM for 6 months or longer at the time of screening based on the World Health Organization (WHO) classification.

  • Treated with stable insulin regimen as follow for at least 3 months with or without oral antidiabetic drug:

    1. Basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine, insulin degludec, insulin detemir) in combination with at least 1 prandial injection of bolus insulin.
    2. Premixed insulin at least twice daily.

Exclusion Criteria:

  • Have other types of diabetes other than T2DM.
  • Have used Glucagon-Like Peptide 1 (GLP-1) receptor agonist within 3 months prior to screening.
  • Have had 1 or more episodes of severe hypoglycemia within the 6 months prior to screening.
  • Have had 1 or more episodes of acute diabetic complications (diabetic ketoacidosis, hyperglycemic hyperosmolar state, diabetic lactic acidosis, etc.) within the 6 months prior to screening.
  • With concomitant conditions at screening that may affect the evaluation of the study, including cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, liver diseases, kidney diseases, nervous system diseases, psychiatric diseases, hematological diseases, immune system diseases, endocrine system diseases, pancreatic diseases, and/or malignant tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Insulin Lispro Injection
Drug: Insulin Lispro Injection
Drug:Insulin Lispro Injection Injected subcutaneously three times a day. Dose was individually adjusted.
Experimental: THDB0206 Injection
Drug: THDB0206 Injection
Drug: THDB0206 Injection Injected subcutaneously three times a day. Dose was individually adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Time Frame: Week 26
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26
Time Frame: Week 26
Week 26
Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26
Time Frame: Week 26
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tonghua Dongbao Pharmaceutical Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2022

Primary Completion (Actual)

December 10, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THDB0206L02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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