Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets

This study is a post-marketing study aimed at evaluating the effectiveness and safety of proline-containing gliflozin tablets in the real-world clinical treatment of type 2 diabetes mellitus. The study is designed as a multicenter, prospective, observational study. This research does not interfere with clinical diagnosis and treatment, and proline-containing gliflozin tablets may be used as monotherapy or in combination with other therapeutic drugs based on actual needs.

Dosage and administration of proline-containing gliflozin tablets:

For newly diagnosed type 2 diabetes patients: The initial dose is one tablet once daily, taken with meals. For patients requiring enhanced glycemic control who tolerate 25 mg once daily, the dose may be increased to 50 mg once daily, taken with meals.

This study includes a screening period (D-14 to D0) and a treatment period (12 weeks ± 7 days, 24 weeks ± 28 days, 48 weeks ± 28 days), totaling 4 visit points. During the study, patients may undergo examinations based on actual clinical needs. The trial requires recording patients' baseline physical examinations, study drug prescription and concomitant medication use, examinations performed according to clinical needs, and the occurrence of adverse events or adverse drug reactions.

The EQ-5D score will be assessed for all subjects. Additionally, for subjects aged 50 years or older (with an education level of elementary school or above), the MoCA (Version 7.1) score and cognitive impairment assessment will be conducted at all visit points except the second one.