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NCT06263348 | RECRUITING | Type2diabetes

A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes
Sponsor:

Hua Medicine Limited

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.

Condition or disease

Type2diabetes

Intervention/treatment

Dorzagliatin tablets

Phase

PHASE4

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 Type : INTERVENTIONAL
Estimated Enrollment : 2000 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : 2023-12-20
Estimated Primary Completion Date : 2026-04-30
Estimated Study Completion Date : 2026-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes

Location Details

NCT06263348

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Beijing

China-Japan Friendship Hospital

Beijing, Beijing, China, 100029

RECRUITING

China, Beijing

China-Japan Friendship Hospital

Beijing, Beijing, China, 100029