Observes real-world use of Proline Plus Empagliflozin tablets in type 2 diabetes
Observes how Proline Plus Empagliflozin tablets are used in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
Key facts
- Where
- Nanjing and Xinyang, ChinaSee the 2 sites
Where in China
- Affiliated Drum Tower Hospital, Medical School of Nanjing UniversityNanjing, ChinaTaking people
- Xinyang Central HospitalXinyang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Trial code
- NCT07023172
- Record updated
- 5 February 2026
- Original description
This study is a post-marketing, multicenter, prospective, observational study designed to evaluate the efficacy and safety of Proline Plus Empagliflozin Tablets in the real-world clinical treatment of type 2 diabetes mellitus. The study does not interfere with routine clinical practice, and Proline Plus Empagliflozin Tablets may be used either as monotherapy or in combination with other therapeutic agents based on actual clinical needs.Read full original descriptionShow less
Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
This study is a post-marketing, multicenter, prospective, observational study designed to evaluate the efficacy and safety of Proline Plus Empagliflozin Tablets in the real-world clinical treatment of type 2 diabetes mellitus. The study does not interfere with routine clinical practice, and Proline Plus Empagliflozin Tablets may be used either as monotherapy or in combination with other therapeutic agents based on actual clinical needs.
Inclusion: 1.Age ≥18 years, regardless of gender. 2.Clinically diagnosed with type 2 diabetes mellitus (per the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus [2020 Edition]); 3.Deemed suitable by the investigator for treatment with proline-containing gliflozin tablets (Hui You Jing) and being prescribed this medication for the first time; 4.Availability of glycated hemoglobin (HbA1c) test results within 4 weeks prior to enrollment; 5.Voluntary participation with signed informed consent.
Exclusion: 1.History of moderate to severe renal impairment (eGFR <30 mL/min/1.73 m²), end-stage renal disease, or dialysis; 2.Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Severe allergy to gliflozin or any excipient of the study drug. 3.Current or recent (within 1 month) participation in any other clinical trial. 4.Investigator judgment of unsuitability for the study.