Clinical trial NCT07003191: Metformin Hydrochloride and Empagliflozin Tablets in the Treatment of Type 2 Diabetes
Official title: Multicenter, Prospective, Observational Study of Metformin Hydrochloride and Empagliflozin Tablets (Enshuangping) in the Treatment of Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Type 2 Diabetes
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Liaoning Health Industry Group Fushun Mining General Hospital
name: Liaoning Health Industry Group Benxi Steel General Hospital
name: Changsha Fourth Hospital
name: Second Hospital of Shanxi Medical University
name: The First People's Hospital of Kunshan
name: Suzhou Ninth People's Hospital
name: the First Affiliated Hospital of Anhui University of Science and Technology
name: Mingguang People's Hospital
name: the People's Hospital Longhua Shenzhen
name: Afﬁliated Hospital of North Sichuan Medical College
name: Yiyang County People's Hospital
name: THE SECOND PEOPLE'S HOSPITAL, WUHU
name: The First People's Hospital of Zhangjiagang
name: Yixing People's Hospital
name: Shijiazhuang People's Hospital
name: Guiyang First People's Hospital
name: Lanzhou University Second Hospital
name: Tiefa Coal Industry Group General Hospital
name: Southern Medical University Shenzhen Hospital
name: The Second Hospital of Shijiazhuang
name: Ningbo University Affiliated People's Hospital
name: Dongyang People's Hospital
name: Xiangyang Central Hospital
name: Li Hui Li Hospital
name: Nanning Second People's Hospital
name: Hunan Provincial People's Hospital Ma Wang Dui Branch
name: The Second Affiliated Hospital of Bengbu Medical College
name: Ruyang County People's Hospital
name: Kaifeng People's Hospital
name: Dingzhou People's Hospital
name: The Second People's Hospital of Changshu
name: The Second Affiliated Hospital of Henan University of Science and Technology
name: Dengzhou People's Hospital
name: Taizhou First People's Hospital
name: Red Cross Hospital, Hangzhou, China
name: The First People's Hospital of Lin'an District
name: China Resources Wugang General Hospital
name: Yiwu Central Hospital
name: The First People's Hospital of Jiashan County
name: The First People's Hospital of Tongxiang City
name: Shaoxing Central Hospital
name: The First People's Hospital of Jiande City
name: Beilun District People's Hospital
name: Huantai County People's Hospital
name: Fifth Affiliated Hospital of Guangzhou Medical University
name: The Sixth Hospital of Wuhan
name: The Affiliated Hospital of Shaanxi University of Chinese Medicine
name: Zhangjiagang Traditional Chinese Medicine Hospital
First posted: 2025-06-04
Enrollment: 2600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient and inpatient patients

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.


Eligibility criteria: 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 outcomes:
measure: 6-month clinical glycemic control rate
timeFrame: 6 months
Secondary outcomes:
measure: Change in HbA1c from baseline
timeFrame: 12 months
measure: Change of β cell function
timeFrame: 12 months
measure: Change of insulin sensitivity
timeFrame: 12 months
measure: Change of lipid profiles
timeFrame: 12 months
measure: Change of body weight
timeFrame: 12 months
measure: Changes in echocardiographic indicators in type 2 diabetes patients with cardiovascular disease
timeFrame: 12 months
measure: Change of blood pressure
timeFrame: 12 months
measure: Change of Quality of life assessment (EQ-5D)
timeFrame: 12 months
measure: Incidence of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Endocrinology Department, The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: