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

NCT ID: NCT06263348

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2026-04-30

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.

Conditions

Type2diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dorzagliatin group

Dorzagliatin tablet (75 mg, BID) treatment for 52 weeks

Group Type: EXPERIMENTAL

Dorzagliatin tablets

Intervention Type: DRUG

During the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions.

Interventions

Dorzagliatin tablets

During the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Hua Medicine Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Zhang, MD,PhD

Role: CONTACT

yzhang@huamedicine.com

+8618502130980

Facility Contacts

Wenying Yang, MD,PhD

Role: primary

Bo Zhang, MD,PhD

Role: primary

Other Identifiers

HMM0601

Identifier Type: -

Identifier Source: org_study_id