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

Active, not recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT07003191
• Lead Sponsor: Sun Yat-sen University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-02
• Study First Submitted: 2025-01-14
• Status Verified: 2025-05
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-month clinical glycemic control rate	6 months	6-month clinical glycemic control rate (clinical control defined as HbA1c \< 7.0%)

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline	12 months	Change in HbA1c from baseline at 12 months
Change of β cell function	12 months	Change of β cell function at 12 months
Change of insulin sensitivity	12 months	Change of insulin sensitivity indicators at the end of study
Change of body weight	12 months	Change of body weight at the end of study
Change of blood pressure	12 months	Change of blood pressure at the end of study
Change of Quality of life assessment (EQ-5D)	12 months	Change of Quality of life assessment (EQ-5D) at the end of study
Incidence of adverse events	12 months	incidence of adverse events at the end of study
Changes in echocardiographic indicators in type 2 diabetes patients with cardiovascular disease	12 months	Changes in echocardiographic indicators in type 2 diabetes patients with cardiovascular disease at the end of study
Change of lipid profiles	12 months	Change of cholesterol, Triglyceride, high-density lipoprotein cholesterol (HDL-c) and low-density lipoprotein cholesterol (LDL-c) at the end of study

Trial Locations

Locations (1)

Endocrinology Department, The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China