Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
Recruiting · NCT07023172 · Observational (researchers observe without assigning treatment) · Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- \- 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
2 locations listed.
- Xinyang Central Hospital - Xinyang, Henan, China
- Affiliated Drum Tower Hospital, Medical School of Nanjing University - Nanjing, Jiangsu, China