Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
Recruiting now
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT07023172
- Run by
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- People needed
- 3000
- Starts
- 2025-05-30
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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]).
- Deemed suitable by the investigator for treatment with proline-containing gliflozin tablets (Hui You Jing) and being prescribed this medication for the first time.
- Availability of glycated hemoglobin (HbA1c) test results within 4 weeks prior to enrollment.
- Voluntary participation with signed informed consent.
You may not qualify if…
- 1.History of moderate to severe renal impairment (eGFR <30 mL/min/1.73 m²), end-stage renal disease, or dialysis.
- 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.
Where it is running
- Xinyang Central Hospital — Xinyang, Henan, China (enrolling)
- Affiliated Drum Tower Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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