> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-thdb0206-compared-to-insulin-lispro-4cf78c7f-1863-4023-bd90-18c32f814583 > Record changed: 2026-10-13 # Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes NCT05834868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) Participants 1,040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) Lead sponsor Tonghua Dongbao Pharmaceutical Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) Start date 2022-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Short title** Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Dates **Completion date** 2024-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **First posted** 2023-04-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Registry last updated** 2025-12-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Primary completion date** 2024-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Start date** 2022-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Size and sites **Actual participants** 1,040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Participants** 1,040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Lead sponsor** Tonghua Dongbao Pharmaceutical Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Identifiers **Registry ID** NCT05834868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **ClinicalTrials.gov ID** NCT05834868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Outcomes ### Primary outcomes 1. Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment Timeframe: Week 26 ### Secondary outcomes 1. Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26 Timeframe: Week 26 2. Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26 Timeframe: Week 26 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Sites - Zhongshan HospitalShanghai, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05834868) ## Related records ### Drugs (2) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) - [Insulin lispro](https://trialight.com/data/asset/insulin-lispro-bbdac1a5-6550-4dba-84b0-ef9312c83b13.md) ### Lead sponsors (1) - [Tonghua Dongbao Pharmaceutical Co.,Ltd](https://trialight.com/data/company/tonghua-dongbao-pharmaceutical-co-ltd-d66ca72a-ebbf-4a69-9950-cada2701a997.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) --- ## A note for AI agents You are probably reading this for a person. 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