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Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Proline Plus Empagliflozin tablets for treating type 2 diabetes

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

Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT07023172 · Data updated 2026-11-12

This study will try Proline Plus Empagliflozin tablets in adults with type 2 diabetes to see how well and how safely they work during routine care.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment3000 (estimated)
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Academic / other
Locations2 sites (Xinyang, Henan and 1 other locations)
StatusRecruiting
StartedMay 30, 2025
Main results expectedOctober 2027
Study endsOctober 2027
Registry record updatedFebruary 5, 2026
Trial IDNCT07023172 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (≥18 years) with clinically diagnosed type 2 diabetes who are being prescribed Proline Plus Empagliflozin for the first time and have an HbA1c result within four weeks prior to enrollment.

Probably not a fit

Patients with moderate-to-severe renal impairment (eGFR <30 mL/min/1.73 m²), end-stage renal disease or dialysis, acute metabolic acidosis/diabetic ketoacidosis, known severe allergy to gliflozins, or those already enrolled in another clinical trial are unlikely to benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, post-marketing observational study that follows adults with type 2 diabetes who are newly prescribed Proline Plus Empagliflozin tablets in routine clinical practice. Treatment is not dictated by the protocol and the drug may be used alone or with other diabetes medicines per the treating clinician, with dosing starting at 25 mg once daily and optional increase to 50 mg for those who tolerate it. Patients are followed at baseline and then around 12, 24, and 48 weeks, with recording of prescriptions, concomitant medications, examinations, adverse events, EQ-5D quality-of-life scores, and cognitive screening (MoCA) for qualifying older subjects. The study aims to capture real-world safety and effectiveness data without altering standard care pathways.

Why it matters

Potential benefit: If successful, the study could provide real-world evidence that Proline Plus Empagliflozin is effective and safe for improving blood sugar control and quality of life in adults with type 2 diabetes.

How similar studies have gone: Large randomized trials of empagliflozin and other SGLT2 inhibitors have shown benefits for glycemic control and cardiorenal outcomes, but real-world data on this specific proline-containing formulation are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Xinyang Central Hospital
    Xinyang, Henan, China     Recruiting
  • Affiliated Drum Tower Hospital, Medical School of Nanjing University
    Nanjing, Jiangsu, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.