A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus

HMM0601

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.

2023-12-20

2026-04-30

2026-04-30

Recruiting

Early phase I

2000

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "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.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2000, 'type': 'ESTIMATED'}}

2024-02-16