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Clinical Trials in China / NCT07003191
Active, not recruiting Observational

Metformin Hydrochloride and Empagliflozin Tablets in the Treatment of Type 2 Diabetes

NCT07003191 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Observational
Started
2023-08-02
Last updated
2025-06-04

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

Metformin Hydrochloride and Empagliflozin tables (Fixed-Dose Combination)

Metformin Hydrochloride and Empagliflozin tables (Fixed-Dose Combination): First-time treatment with Metformin Hydrochloride and Empagliflozin Tablets (metformin 500mg and empagliflozin 5mg per table) for at least 6 months

Study 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 total of 2,600 type 2 diabetes patients were included in the study. The study observed the clinical glycemic control rate and adverse events over a period of at least 6 months from the prescription date to the end of continuous clinical follow-up.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years, gender unrestricted; 2. Clinically diagnosed with type 2 diabetes; 3. First-time treatment with metformin and empagliflozin tablets; 4. HbA1c test results within 2 weeks prior to enrollment (rapid fingertip test results are acceptable); 5. Voluntary participation in the study and signing of informed consent form. Exclusion Criteria: 1. Moderate to severe renal impairment (eGFR \< 45 mL/min/1.73 m²), end-stage renal disease, or dialysis; 2. Acute or chronic metabolic acidosis, including diabetic ketoacidosis; 3. A history of severe allergy to empagliflozin, metformin, or any excipient in this product; 4. Currently or within the past month, participation in any other clinical trials; 5. Judged by the investigator to be unsuitable for participation in this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Endocrinology Department, The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

More Sun Yat-sen University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07003191 on ClinicalTrials.gov ↗ ← All trials in China