Type 2 DiabetesPhase 3NCT05834868
Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes
A Phase 3 study testing THDB0206 Injection and Insulin Lispro Injection in people with Type 2 Diabetes, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- THDB0206 Injection and Insulin Lispro Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2022to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- THDB0206 Injection, Insulin Lispro Injection
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THDB0206 InjectionDrug
Drug: THDB0206 Injection Injected subcutaneously three times a day. Dose was individually adjusted.
Insulin Lispro InjectionDrug
Drug:Insulin Lispro Injection Injected subcutaneously three times a day. Dose was individually adjusted.
| Study group | Role | What they receive |
|---|---|---|
| THDB0206 Injection | Experimental | Not described Receives: Drug: THDB0206 Injection |
| Insulin Lispro Injection | Active comparator | Not described Receives: Drug: Insulin Lispro Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Measured: Week 26
Secondary outcomes (2)
Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26
Measured: Week 26
Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start6 May 2022
- Primary completion10 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834868
- Sponsor's protocol ID
- THDB0206L02
- Status last verified
- Dec 2025
- First submitted
- 17 Apr 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05834868
- Acronym / sponsor ID
- THDB0206L02
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 6 May 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THDB0206 Injection | Experimental | Drug: THDB0206 Injection |
| Insulin Lispro Injection | Active comparator | Drug: Insulin Lispro Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THDB0206 InjectionDrug: THDB0206 Injection Injected subcutaneously three times a day. Dose was individually adjusted. | Drug | THDB0206 Injection |
| Insulin Lispro InjectionDrug:Insulin Lispro Injection Injected subcutaneously three times a day. Dose was individually adjusted. | Drug | Insulin Lispro Injection |
Primary outcome
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Time frame: Week 26
2 secondary outcomes
Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26
Time frame: Week 26
Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26
Time frame: Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing THDB0206 Injection and Insulin Lispro Injection in people with Type 2 Diabetes, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.