Observational Study on Proline Plus Empagliflozin Tablets for Treating Type 2 Diabetes in Adults

What this Trial Is About

Researchers are conducting a multicenter, prospective observational study to evaluate the effectiveness and safety of Proline Plus Empagliflozin Tablets in treating type 2 diabetes mellitus in real-world clinical settings. This post-marketing study does not interfere with routine care and allows the drug to be used alone or alongside other treatments based on patient needs. The study aims to better understand how this medication performs across different patient subgroups and conditions. Participants prescribed Proline Plus Empagliflozin Tablets will follow a treatment plan with doses starting at one tablet once daily with meals. For those needing stronger blood sugar control and tolerating the initial dose, the medication may be increased to two tablets once daily. The study includes a screening period up to 14 days before treatment, followed by three treatment follow-up visits at approximately 12, 24, and 48 weeks to monitor outcomes. During the study, researchers will collect data from routine examinations, medication use, and any side effects or adverse events. Patients will complete quality of life assessments EQ-5D, while those aged 50 or older with at least elementary education will also undergo cognitive testing MoCA. The primary outcome is achieving blood sugar control with HbA1c below 7.0% at 24 weeks. Additional analyses will explore effects in subgroups based on age, HbA1c levels, body mass index, other medications, and related health conditions like kidney, heart, eye diseases, and cognitive impairment.

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