NCT07023172 Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
| NCT ID | NCT07023172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Type 2 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2025-05-30 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2025-05-30 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07023172 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07023172 currently recruiting?
Yes, NCT07023172 is actively recruiting participants. Contact the research team at biyan@nju.edu.cn for enrollment information.
Where is the NCT07023172 trial being conducted?
This trial is being conducted at Xinyang, China, Nanjing, China.
Who is sponsoring the NCT07023172 clinical trial?
NCT07023172 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 3,000 participants.
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