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

NCT05834868 | Completed Phase 3

• 1 other identifier: THDB0206L02
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Week 26

Secondary Outcomes (2)

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

  Week 26

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

  Week 26

Study Arms (2)

THDB0206 Injection

EXPERIMENTAL

Drug: THDB0206 Injection

Insulin Lispro Injection

ACTIVE COMPARATOR

Drug: Insulin Lispro Injection

Interventions

THDB0206 Injection DRUG

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

THDB0206 Injection

Insulin Lispro Injection DRUG

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

Insulin Lispro Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tonghua Dongbao Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 28, 2023
• Study Start: May 6, 2022
• Primary Completion: December 10, 2024
• Study Completion: December 31, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

CN (1)