NCT05834868CompletedPhase 3
Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes
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 · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1040 (actual)
- First submitted
- 17 Apr 2023
- Start date
- 6 May 2022
- Primary completion date
- 10 Dec 2024
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Diseases
- Type 2 diabetes
- NCT number
- NCT05834868
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1040
- From 6 May 2022 to the primary completion date, 10 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Have other types of diabetes other than T2DM.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.