New insulin candidate tested in 1,040 chinese diabetes patients
NCT ID NCT05834868
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new insulin called THDB0206 against a standard insulin (lispro) in 1,040 Chinese adults with type 2 diabetes. Both were used alongside a long-acting insulin. The goal was to see if the new insulin works as well or better at controlling blood sugar over 26 weeks. Participants had diabetes for at least 6 months and were already on insulin therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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1,040 people
The number who actually took part.
- Started
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May 2022
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Zhongshan Hospital
Shanghai, China
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