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

Phase 4

Recruiting

• Conditions: Type2diabetes
• Interventions: Drug: Dorzagliatin tablets

• Registration Number: NCT06263348
• Lead Sponsor: Hua Medicine Limited

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.

Study Timeline

• Study Start: 2023-12-20
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dorzagliatin group	Dorzagliatin tablets	Dorzagliatin tablet (75 mg, BID) treatment for 52 weeks

Primary Outcome Measures

Name	Time	Method
Incidences of ADRs and SAEs	52 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Response rate	52 weeks	The proportion of patients with HbA1c \< 7% after 52 weeks of treatment
Blood glucose indicators	52 weeks	Changes from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and 2-hour postprandial plasma glucose (2h-PPG) after 52 weeks of treatment with Dorzagliatin

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China