Type 1 DiabetesPhase 3NCT07282054
Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes
A Phase 3 study testing THDB0206, Insulin Lispro and Insulin Glargine in people with Type 1 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 T1DM. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- THDB0206, Insulin Lispro and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2022to 24 Jan 2025
- 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
- Male or female participants, 18 to 75 years of age at informed consent (inclusive).
- BMI between 18.0 and 30.0 kg/m² (inclusive).
- T1DM diagnosed ≥6 months per WHO diabetes classification (2019).
- On insulin therapy ≥6 months prior to screening.
- Stable insulin regimen ≥3 months prior to screening (no change in insulin class), with or without metformin or alpha-glucosidase inhibitors; willing to follow multiple daily injections:
- Intermediate/long-acting insulin once or twice daily (e.g., NPH, glargine, detemir, degludec); plus prandial insulin 1~3 times daily (or as per usual diet) (e.g., regular human insulin, lispro, aspart, glulisine).
- Premixed insulin ≥2 times per day.
- Screening HbA1c between 7.0% and 11.0% (inclusive), measured by the central laboratory.
Who cannot join
- Diabetes other than T1DM.
- History of pancreatectomy.
- Prior pancreatic and/or islet cell transplantation.
- ≥1 episode of Level 3 hypoglycemia within 6 months before screening (requires external assistance).
- Hepatic or renal impairment at screening (per local laboratory reference ranges):
- AST or ALT ≥3× ULN; and/or
Show all 13Show fewer
- TBL ≥2× ULN (except Gilbert syndrome); and/or
- Estimated creatinine clearance <45 mL/min (Cockcroft-Gault).
- Known hypersensitivity/allergy to study insulin products or excipients, or to any component of the standardized test meal.
- Blood transfusion or major blood loss within 3 months before screening; hemoglobinopathies, moderate-severe anemia, or other conditions that may interfere with HbA1c measurement.
- Use of oral antihyperglycemics within 3 months before screening (except metformin and alpha-glucosidase inhibitors), or use of non-insulin injectables (e.g., GLP-1 receptor agonists).
- Systemic corticosteroid therapy for ≥14 consecutive days within 3 months prior to screening (including IV, IM, SC, or oral routes; excluding topical, intraocular, intranasal, intra-articular, and inhaled use), or systemic corticosteroid therapy within 8 weeks prior to screening (except physiologic replacement for adrenal insufficiency), or anticipated need for prolonged systemic corticosteroid therapy during the study.
- Use within 3 months before screening, or current use, of traditional medicines (herbal or proprietary Chinese medicines) with known glucose-lowering effects.
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 1 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 T1DM.
- Conditions
- Type 1 Diabetes
- Being tested
- THDB0206, Insulin Lispro, Insulin Glargine
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THDB0206Drug
Subcutaneous THDB0206 three times daily, with individualized dose adjustment.
Insulin LisproDrug
Subcutaneous insulin lispro three times daily, with individualized dose adjustment.
Insulin GlargineDrug
Subcutaneous insulin glargine once daily, with individualized dose adjustment.
| Study group | Role | What they receive |
|---|---|---|
| THDB0206 Injection | Experimental | Not described Receives: Drug: THDB0206; Drug: Insulin Glargine |
| Insulin Lispro Injection | Active comparator | Not described Receives: Drug: Insulin Lispro; Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in HbA1c at Week 26
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 posted15 Dec 2025
- Study start13 Apr 2022
- Primary completion23 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- 550 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
- NCT07282054
- Sponsor's protocol ID
- THDB0206L01
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 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 1 Diabetes
- ClinicalTrials.gov ID
- NCT07282054
- Acronym / sponsor ID
- THDB0206L01
- Conditions
- Type 1 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 15 Dec 2025 (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 T1DM.
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, Drug: Insulin Glargine |
| Insulin Lispro Injection | Active comparator | Drug: Insulin Lispro, Drug: Insulin Glargine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participants, 18 to 75 years of age at informed consent (inclusive).
- BMI between 18.0 and 30.0 kg/m² (inclusive).
- T1DM diagnosed ≥6 months per WHO diabetes classification (2019).
- On insulin therapy ≥6 months prior to screening.
- Stable insulin regimen ≥3 months prior to screening (no change in insulin class), with or without metformin or alpha-glucosidase inhibitors; willing to follow multiple daily injections:
Key exclusion criteria (13 listed)
- Diabetes other than T1DM.
- History of pancreatectomy.
- Prior pancreatic and/or islet cell transplantation.
- ≥1 episode of Level 3 hypoglycemia within 6 months before screening (requires external assistance).
- Hepatic or renal impairment at screening (per local laboratory reference ranges):
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 |
|---|---|---|
| THDB0206Subcutaneous THDB0206 three times daily, with individualized dose adjustment. | Drug | THDB0206 Injection |
| Insulin LisproSubcutaneous insulin lispro three times daily, with individualized dose adjustment. | Drug | Insulin Lispro Injection |
| Insulin GlargineSubcutaneous insulin glargine once daily, with individualized dose adjustment. | Drug | Insulin Lispro Injection, THDB0206 Injection |
Primary outcome
Change from Baseline in HbA1c at Week 26
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 15 Dec 2025.
- Individual participant dataSharing planned: No
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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, Insulin Lispro and Insulin Glargine in people with Type 1 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 8 inclusion and 13 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 15 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 from Baseline in HbA1c at Week 26 (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 15 Dec 2025.