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NCT Number: NCT05834868

Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THDB0206 Injection

Drug

Drug: THDB0206 Injection Injected subcutaneously three times a day. Dose was individually adjusted.

Insulin Lispro Injection

Drug

Drug:Insulin Lispro Injection Injected subcutaneously three times a day. Dose was individually adjusted.

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

    Time frame: Week 26

Secondary outcomes

  1. Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26

    Time frame: Week 26

  2. Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26

    Time frame: Week 26

Sponsors and collaborators

Lead sponsor

Tonghua Dongbao Pharmaceutical Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2023
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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