Type2diabetesPhase 4BLOOMNCT06263348
A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes
A Phase 4 study testing Dorzagliatin tablets in people with Type2diabetes, run by Hua Medicine Limited at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Dorzagliatin tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,024 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2024to 30 Apr 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Patients must meet all of the following inclusion criteria to be eligible for this study:
- Male or female ≥ 18 years of age at the time of signing the informed consent form;
- Patients with type 2 diabetes mellitus diagnosed at screening;
- Patients who have been prescribed Dorzagliatin according to the package insert and physician's judgment (the prescription should be made before enrolling the patient in this study and is independent of the enrollment decision);
- Willingness to participate in the study and sign written informed consent.
Who cannot join
- -
- Patients will not be eligible if they meet any of the following criteria:
- Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes;
- Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin;
- Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus
The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin.
Read the detailed description
This study adopts a multicenter, prospective, and observational cohort study design and does not involve randomization, control, and blinding. Patients with type 2 diabetes mellitus who were prescribed Dorzagliatin according to the package insert and physician's judgment in routine medical practice setting will be included, and the data of these patients during 52-week Dorzagliatin treatment will be collected to evaluate the safety of long-term medication.
- Conditions
- Type2diabetes
- Being tested
- Dorzagliatin tablets
- Keywords
- Post-Marketing, long term Safety, Dorzagliatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorzagliatin tabletsDrug
During the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions.
| Study group | Role | What they receive |
|---|---|---|
| Dorzagliatin group | Experimental | Dorzagliatin tablet (75 mg, BID) treatment for 52 weeks Receives: Drug: Dorzagliatin tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of ADRs and SAEs
The incidences of adverse drug reactions (ADRs) and serious adverse events (SAEs) as well as ADRs of special interest during the 52-week observation period of Dorzagliatin treatment.
Measured: 52 weeks
Secondary outcomes (2)
Blood glucose indicators
Changes from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment with Dorzagliatin
Measured: 52 weeks
Response rate
The proportion of patients with HbA1c < 7% after 52 weeks of treatment
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start17 Jan 2024
- Primary completion31 Dec 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The marketed product - Dorzagliatin tablet (HuaTangNing®) is used as the study drug. During this study, the dosage and administration of Dorzagliatin tablets will be completely in accordance with the investigator's judgment based on the package insert and the patient's condition.
- Masking
- None (open label)
- Enrolment
- 2,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kun Tuo Xincheng Pharmaceutical Researchand Development(Beijing)Co.,Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263348
- Sponsor's protocol ID
- HMM0601
- Acronym
- BLOOM
- Status last verified
- Jul 2026
- First submitted
- 5 Feb 2024
- Last updated
- 10 Jul 2026
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06263348
- Acronym / sponsor ID
- BLOOM / HMM0601
- Conditions
- Type2diabetes
- Keywords
- Post-Marketing, long term Safety, Dorzagliatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,024 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Kun Tuo Xincheng Pharmaceutical Researchand Development(Beijing)Co.,Ltd.
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 16 Feb 2024 (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.
The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin.
Detailed description
This study adopts a multicenter, prospective, and observational cohort study design and does not involve randomization, control, and blinding. Patients with type 2 diabetes mellitus who were prescribed Dorzagliatin according to the package insert and physician's judgment in routine medical practice setting will be included, and the data of these patients during 52-week Dorzagliatin treatment will be collected to evaluate the safety of long-term medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The marketed product - Dorzagliatin tablet (HuaTangNing®) is used as the study drug. During this study, the dosage and administration of Dorzagliatin tablets will be completely in accordance with the investigator's judgment based on the package insert and the patient's condition.
| Arm | Type | Receives |
|---|---|---|
| Dorzagliatin group | Experimental | Drug: Dorzagliatin tabletsDorzagliatin tablet (75 mg, BID) treatment for 52 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -
- Male or female ≥ 18 years of age at the time of signing the informed consent form;
- Patients with type 2 diabetes mellitus diagnosed at screening;
- Patients who have been prescribed Dorzagliatin according to the package insert and physician's judgment (the prescription should be made before enrolling the patient in this study and is independent of the enrollment decision);
- Willingness to participate in the study and sign written informed consent.
Key exclusion criteria (5 listed)
- -
- Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes;
- Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin;
- Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study.
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 |
|---|---|---|
| Dorzagliatin tabletsDuring the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions. | Drug | Dorzagliatin group |
Primary outcome
Incidences of ADRs and SAEs
Time frame: 52 weeks
The incidences of adverse drug reactions (ADRs) and serious adverse events (SAEs) as well as ADRs of special interest during the 52-week observation period of Dorzagliatin treatment.
2 secondary outcomes
Blood glucose indicators
Time frame: 52 weeks
Response rate
Time frame: 52 weeks
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 10 Jul 2026.
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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 4 study testing Dorzagliatin tablets in people with Type2diabetes, run by Hua Medicine Limited 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 10 Jul 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidences of ADRs and SAEs (time frame: 52 weeks). 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 10 Jul 2026.