CompletedPhase 4

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

China2,024 participantsStarted 2024-01-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female ≥ 18 years of age at the time of signing the informed consent form;
. Patients with type 2 diabetes mellitus diagnosed at screening;
. 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);
. Willingness to participate in the study and sign written informed consent.

Exclusion criteria

. Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes;
. Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin;
. Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidences of ADRs and SAEs

Timeframe: 52 weeks

Trial details

NCT IDNCT06263348

SponsorHua Medicine Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Type2diabetes trials