Proline Plus Empagliflozin tablets for treating type 2 diabetes
Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
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 type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 2 sites (Xinyang, Henan and 1 other locations) |
| Trial ID | NCT07023172 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Xinyang, Henan and 1 other locations
- Xinyang Central Hospital — Xinyang, Henan, China (Recruiting)
- Affiliated Drum Tower Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Bi Yan
- Email: biyan@nju.edu.cn
- Phone: 86+13655176388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.