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

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin Hydrochloride and Empagliflozin tables (Fixed-Dose Combination)

Study type: Observational

Funder types: Other

Identifiers

NCT07003191

2023-414

Details and patient eligibility

About

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.

Enrollment: 2,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.