Recruiting
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.
ClinicalTrials.gov IDNCT07023172
PhaseNot Applicable
Enrollment3000
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Age18 Years
SexALL
Conditions studied
Type 2 Diabetes
About this study
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.
Primary outcomes
- HbA1c <7.0% (at 24 weeks)
Eligibility information
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 \[2020 Edition\]).
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 Criteria:
\- 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.
Study locations
- Xinyang Central Hospital, Xinyang, Henan 464000 China
- Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu 210000 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.