Clinical trial NCT06263348: A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes
Official title: A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type2diabetes
Keywords: Post-Marketing
long term Safety
Dorzagliatin
Lead sponsor: Hua Medicine Limited
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd.
First posted: 2024-02-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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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:

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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.

Primary outcomes:
measure: Incidences of ADRs and SAEs
timeFrame: 52 weeks
Secondary outcomes:
measure: Blood glucose indicators
timeFrame: 52 weeks
measure: Response rate
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: