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| Name | Class |
|---|---|
| Kun Tuo Xincheng Pharmaceutical Researchand Development(Beijing)Co.,Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorzagliatin group | Experimental | Dorzagliatin tablet (75 mg, BID) treatment for 52 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorzagliatin tablets | Drug | During the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose indicators | Changes from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment with Dorzagliatin | 52 weeks |
| Response rate | The proportion of patients with HbA1c < 7% after 52 weeks of treatment |
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Inclusion Criteria:
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Patients must meet all of the following inclusion criteria to be eligible for this study:
Exclusion Criteria:
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Patients will not be eligible if they meet any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| C000629807 | Dorzagliatin |
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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.
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| 52 weeks |