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Diabetes drug dorzagliatin under Long-Term safety watch

NCT ID NCT06263348

Disease control Sponsor: Hua Medicine Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tracks the long-term safety of dorzagliatin, a drug for type 2 diabetes, in over 2,000 patients over 52 weeks. Researchers monitor side effects and how well the drug controls blood sugar. The goal is to ensure the drug remains safe for everyday use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dorzagliatin
What this could lead to
If successful, this study could confirm that dorzagliatin is safe for long-term use in managing type 2 diabetes.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Side effects may still emerge in larger populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

2,024 people

The number who actually took part.

Started

Jan 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TYPE2DIABETES

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029, China

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