Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
1 other identifier
observational
3,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2025
CompletedFirst Submitted
Initial submission to the registry
June 6, 2025
CompletedFirst Posted
Study publicly available on registry
June 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
February 5, 2026
May 1, 2025
2.3 years
June 6, 2025
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c <7.0%
Glycemic control rate at 24 weeks, where glycemic control is defined as HbA1c \<7.0%
at 24 weeks
Eligibility Criteria
Age ≥18 years, no gender restriction; clinically diagnosed with type 2 diabetes mellitus (per Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus \[2020\]); deemed by investigators as suitable for and initiating empagliflozin treatment for the first time.
You may qualify if:
- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Xinyang Central Hospital
Xinyang, Henan, 464000, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2025
First Posted
June 15, 2025
Study Start
May 30, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
February 5, 2026
Record last verified: 2025-05