Evaluating the long-term safety of Dorzagliatin in type 2 diabetes patients

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

This study is testing the long-term safety of a diabetes medication called Dorzagliatin in people with type 2 diabetes over a year.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hua Medicine Limited (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT06263348 on ClinicalTrials.gov

What this trial studies

This study aims to assess the long-term safety of Dorzagliatin in patients with type 2 diabetes mellitus by collecting clinical safety data in a real-world setting. It employs a multicenter, prospective, observational cohort design without randomization or control groups. Patients who have been prescribed Dorzagliatin will be monitored over a 52-week treatment period to gather safety information. The study will include data from various medical centers to ensure a larger population is evaluated.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with type 2 diabetes and prescribed Dorzagliatin.

Not a fit: Patients with other types of diabetes, such as type 1 diabetes, or those who are allergic to Dorzagliatin will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety profile of Dorzagliatin for patients with type 2 diabetes.

How similar studies have performed: Other studies evaluating the safety of diabetes medications have shown success, but this specific approach to post-marketing safety assessment is relatively novel.

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.

Where this trial is running

Beijing, Beijing and 1 other locations

• China-Japan Friendship Hospital — Beijing, Beijing, China (Recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yi Zhang, MD,PhD

Conditions Type2diabetes; Post-Marketing; long term Safety; Dorzagliatin