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NCT Number: NCT07003191

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Metformin Hydrochloride and Empagliflozin tables (Fixed-Dose Combination)

Drug

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

Primary outcomes

  1. 6-month clinical glycemic control rate

    Time frame: 6 months

    6-month clinical glycemic control rate (clinical control defined as HbA1c < 7.0%)

Secondary outcomes

  1. Change in HbA1c from baseline

    Time frame: 12 months

    Change in HbA1c from baseline at 12 months

  2. Change of β cell function

    Time frame: 12 months

    Change of β cell function at 12 months

  3. Change of insulin sensitivity

    Time frame: 12 months

    Change of insulin sensitivity indicators at the end of study

  4. Change of lipid profiles

    Time frame: 12 months

    Change of cholesterol, Triglyceride, high-density lipoprotein cholesterol (HDL-c) and low-density lipoprotein cholesterol (LDL-c) at the end of study

  5. Change of body weight

    Time frame: 12 months

    Change of body weight at the end of study

  6. Changes in echocardiographic indicators in type 2 diabetes patients with cardiovascular disease

    Time frame: 12 months

    Changes in echocardiographic indicators in type 2 diabetes patients with cardiovascular disease at the end of study

  7. Change of blood pressure

    Time frame: 12 months

    Change of blood pressure at the end of study

  8. Change of Quality of life assessment (EQ-5D)

    Time frame: 12 months

    Change of Quality of life assessment (EQ-5D) at the end of study

  9. Incidence of adverse events

    Time frame: 12 months

    incidence of adverse events at the end of study

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Affiliated Hospital of North Sichuan Medical College
  • Beilun District People's Hospital
  • Changsha Fourth Hospital
  • China Resources Wugang General Hospital
  • Dengzhou People's Hospital
  • Dingzhou People's Hospital
  • Dongyang People's Hospital
  • Fifth Affiliated Hospital of Guangzhou Medical University
  • First Affiliated Hospital, Sun Yat-Sen University
  • First People's Hospital of Hangzhou
  • Huantai County People's Hospital
  • Hunan Provincial People's Hospital Ma Wang Dui Branch
  • Kaifeng People's Hospital
  • Lanzhou University Second Hospital
  • Li Hui Li Hospital
  • Liaoning Health Industry Group Benxi Steel General Hospital
  • Liaoning Health Industry Group Fushun Mining General Hospital
  • Mingguang People's Hospital
  • Nanning Second People's Hospital
  • Red Cross Hospital, Hangzhou, China
  • Ruyang County People's Hospital
  • Second Affiliated Hospital of Bengbu Medical College
  • Second Hospital of Shanxi Medical University
  • Shaanxi Hospital of Traditional Chinese Medicine
  • Shaoxing Central Hospital
  • Shenzhen Hospital of Southern Medical University
  • Shijiazhuang People's Hospital
  • Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
  • Suzhou Ninth People's Hospital
  • THE SECOND PEOPLE'S HOSPITAL, WUHU
  • Taizhou First People's Hospital
  • The Affiliated People's Hospital of Ningbo University
  • The First People's Hospital of Guiyang
  • The First People's Hospital of Jiande City
  • The First People's Hospital of Jiashan County
  • The First People's Hospital of Kunshan
  • The First People's Hospital of Tongxiang City
  • The First People's Hospital of Zhangjiagang
  • The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • The Second Hospital of Shijiazhuang
  • The Second People's Hospital of Changshu
  • Tiefa Coal Industry Group General Hospital
  • Xiangyang Central Hospital
  • Yiwu Central Hospital
  • Yixing People's Hospital
  • Yiyang County People's Hospital
  • Zhangjiagang Traditional Chinese Medicine Hospital
  • the First Affiliated Hospital of Anhui University of Science and Technology
  • the People's Hospital Longhua Shenzhen

Registry information

Official study title

Multicenter, Prospective, Observational Study of Metformin Hydrochloride and Empagliflozin Tablets (Enshuangping) in the Treatment of Type 2 Diabetes

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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