Status:
ACTIVE_NOT_RECRUITING
Metformin Hydrochloride and Empagliflozin Tablets in the Treatment of Type 2 Diabetes
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
First Affiliated Hospital, Sun Yat-Sen University
Liaoning Health Industry Group Fushun Mining General Hospital
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
The main objective of this study is to evaluate the efficacy and safety of Metformin Hydrochloride and Empagliflozin Tablets in the treatment of type 2 diabetes in real-world clinical settings. A tota...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, gender unrestricted;
- Clinically diagnosed with type 2 diabetes;
- First-time treatment with metformin and empagliflozin tablets;
- HbA1c test results within 2 weeks prior to enrollment (rapid fingertip test results are acceptable);
- Voluntary participation in the study and signing of informed consent form.
Exclusion
- Moderate to severe renal impairment (eGFR \< 45 mL/min/1.73 m²), end-stage renal disease, or dialysis;
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
- A history of severe allergy to empagliflozin, metformin, or any excipient in this product;
- Currently or within the past month, participation in any other clinical trials;
- Judged by the investigator to be unsuitable for participation in this study.
Key Trial Info
Start Date :
August 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
2600 Patients enrolled
Trial Details
Trial ID
NCT07003191
Start Date
August 2 2023
End Date
December 31 2025
Last Update
June 4 2025
Active Locations (1)
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1
Endocrinology Department, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China