NCT06263348

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

A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Hua Medicine Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2024-02-16
• Last updated: 2024-02-16

Locations

2 sites across 1 country: China