Type2diabetes
Conditions
Keywords
Post-Marketing, long term Safety, Dorzagliatin
Brief 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.
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.
Interventions
DRUGDorzagliatin tablets
During the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions.
Sponsors
Hua Medicine Limited
Kun Tuo Xincheng Pharmaceutical Researchand Development(Beijing)Co.,Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients must meet all of the following inclusion criteria to be eligible for this study: 1. Male or female ≥ 18 years of age at the time of signing the informed consent form; 2. Patients with type 2 diabetes mellitus diagnosed at screening; 3. 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); 4. Willingness to participate in the study and sign written informed consent.
Exclusion criteria
\- Patients will not be eligible if they meet any of the following criteria: 1. Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes; 2. Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin; 3. Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidences of ADRs and SAEs | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose indicators | 52 weeks | Changes from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment with Dorzagliatin |
| Response rate | 52 weeks | The proportion of patients with HbA1c \< 7% after 52 weeks of treatment |
Countries
China
Outcome results
None listed