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

NCT06263348 | Recruiting Phase 4

• 1 other identifier: HMM0601
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Type2diabetes

Keywords

Post-Marketing; long term Safety; Dorzagliatin

Outcome Measures

Primary Outcomes (1)

• Incidences of ADRs and SAEs

  The incidences of adverse drug reactions (ADRs) and serious adverse events (SAEs) as well as ADRs of special interest during the 52-week observation period of Dorzagliatin treatment.

  52 weeks

Secondary Outcomes (2)

• Blood glucose indicators

  52 weeks

• Response rate

  52 weeks

Study Arms (1)

Dorzagliatin group

EXPERIMENTAL

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

Drug: Dorzagliatin tablets

Interventions

Dorzagliatin tablets 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.

Dorzagliatin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients will not be eligible if they meet any of the following 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.

Sponsors & Collaborators

• Hua Medicine Limited: lead
• Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd.: collaborator

Study Sites (2)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Interventions

Dorzagliatin

Central Study Contacts

Yi Zhang, MD,PhD

CONTACT

+8618502130980; yzhang@huamedicine.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The marketed product - Dorzagliatin tablet (HuaTangNing®) is used as the study drug. During this study, the dosage and administration of Dorzagliatin tablets will be completely in accordance with the investigator's judgment based on the package insert and the patient's condition.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 16, 2024
• Study Start: December 20, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

CN (2)