Type 2 DiabetesNCT07003191
Metformin Hydrochloride and Empagliflozin Tablets in the Treatment of Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Metformin Hydrochloride and Empagliflozin tables (Fixed-Dose Combination)
- Type of treatment
- Pill or oral medicine
- How many people
- 2,600 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2023to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient and inpatient patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Endocrinology Department, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
About this study
Official title: Multicenter, Prospective, Observational Study of Metformin Hydrochloride and Empagliflozin Tablets (Enshuangping) 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Metformin Hydrochloride and Empagliflozin tables (Fixed-Dose Combination)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month clinical glycemic control rate
6-month clinical glycemic control rate (clinical control defined as HbA1c < 7.0%)
Measured: 6 months
Secondary outcomes (9)
Change in HbA1c from baseline
Change in HbA1c from baseline at 12 months
Measured: 12 months
Change of β cell function
Change of β cell function at 12 months
Measured: 12 months
Change of insulin sensitivity
Change of insulin sensitivity indicators at the end of study
Measured: 12 months
Change of lipid profiles
Change of cholesterol, Triglyceride, high-density lipoprotein cholesterol (HDL-c) and low-density lipoprotein cholesterol (LDL-c) at the end of study
Measured: 12 months
Change of body weight
Change of body weight at the end of study
Measured: 12 months
Changes in echocardiographic indicators in type 2 diabetes patients with cardiovascular disease
Changes in echocardiographic indicators in type 2 diabetes patients with cardiovascular disease at the end of study
Measured: 12 months
Change of blood pressure
Change of blood pressure at the end of study
Measured: 12 months
Change of Quality of life assessment (EQ-5D)
Change of Quality of life assessment (EQ-5D) at the end of study
Measured: 12 months
Incidence of adverse events
incidence of adverse events at the end of study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start2 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Liaoning Health Industry Group Fushun Mining General Hospital, Liaoning Health Industry Group Benxi Steel General Hospital, Changsha Fourth Hospital, Second Hospital of Shanxi Medical University, The First People's Hospital of Kunshan, Suzhou Ninth People's Hospital, the First Affiliated Hospital of Anhui University of Science and Technology, Mingguang People's Hospital, the People's Hospital Longhua Shenzhen, Affiliated Hospital of North Sichuan Medical College, Yiyang County People's Hospital, Wuhu City Second People's Hospital, The First People's Hospital of Zhangjiagang, Yixing People's Hospital, Shijiazhuang People's Hospital, The First People's Hospital of Guiyang, Lanzhou University Second Hospital, Tiefa Coal Industry Group General Hospital, Shenzhen Hospital of Southern Medical University, The Second Hospital of Shijiazhuang, The Affiliated People's Hospital of Ningbo University, Dongyang People's Hospital, Xiangyang Central Hospital, Li Hui Li Hospital, Nanning Second People's Hospital, Hunan Provincial People's Hospital Ma Wang Dui Branch, Second Affiliated Hospital of Bengbu Medical College, Ruyang County People's Hospital, Kaifeng People's Hospital, Dingzhou People's Hospital, The Second People's Hospital of Changshu, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, Dengzhou People's Hospital, Taizhou First People's Hospital, Red Cross Hospital, Hangzhou, China, First People's Hospital of Hangzhou, China Resources Wugang General Hospital, Yiwu Central Hospital, The First People's Hospital of Jiashan County, The First People's Hospital of Tongxiang City, Shaoxing Central Hospital, The First People's Hospital of Jiande City, Beilun District People's Hospital, Huantai County People's Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University, Shaanxi Hospital of Traditional Chinese Medicine, Zhangjiagang Traditional Chinese Medicine Hospital
- Responsible party
- Principal investigator, Yanbing Li, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003191
- Sponsor's protocol ID
- 2023-414
- Status last verified
- May 2025
- First submitted
- 14 Jan 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Observational Study of Metformin Hydrochloride and Empagliflozin Tablets (Enshuangping) in the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07003191
- Acronym / sponsor ID
- 2023-414
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Liaoning Health Industry Group Fushun Mining General Hospital, Liaoning Health Industry Group Benxi Steel General Hospital, Changsha Fourth Hospital, Second Hospital of Shanxi Medical University, The First People's Hospital of Kunshan, Suzhou Ninth People's Hospital, the First Affiliated Hospital of Anhui University of Science and Technology, Mingguang People's Hospital, the People's Hospital Longhua Shenzhen, Affiliated Hospital of North Sichuan Medical College, Yiyang County People's Hospital, Wuhu City Second People's Hospital, The First People's Hospital of Zhangjiagang, Yixing People's Hospital, Shijiazhuang People's Hospital, The First People's Hospital of Guiyang, Lanzhou University Second Hospital, Tiefa Coal Industry Group General Hospital, Shenzhen Hospital of Southern Medical University, The Second Hospital of Shijiazhuang, The Affiliated People's Hospital of Ningbo University, Dongyang People's Hospital, Xiangyang Central Hospital, Li Hui Li Hospital, Nanning Second People's Hospital, Hunan Provincial People's Hospital Ma Wang Dui Branch, Second Affiliated Hospital of Bengbu Medical College, Ruyang County People's Hospital, Kaifeng People's Hospital, Dingzhou People's Hospital, The Second People's Hospital of Changshu, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, Dengzhou People's Hospital, Taizhou First People's Hospital, Red Cross Hospital, Hangzhou, China, First People's Hospital of Hangzhou, China Resources Wugang General Hospital, Yiwu Central Hospital, The First People's Hospital of Jiashan County, The First People's Hospital of Tongxiang City, Shaoxing Central Hospital, The First People's Hospital of Jiande City, Beilun District People's Hospital, Huantai County People's Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University, Shaanxi Hospital of Traditional Chinese Medicine, Zhangjiagang Traditional Chinese Medicine Hospital
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient and inpatient patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | – |
Primary outcome
6-month clinical glycemic control rate
Time frame: 6 months
6-month clinical glycemic control rate (clinical control defined as HbA1c < 7.0%)
9 secondary outcomes
Change in HbA1c from baseline
Time frame: 12 months
Change of β cell function
Time frame: 12 months
Change of insulin sensitivity
Time frame: 12 months
Change of lipid profiles
Time frame: 12 months
Change of body weight
Time frame: 12 months
Changes in echocardiographic indicators in type 2 diabetes patients with cardiovascular disease
Time frame: 12 months
Change of blood pressure
Time frame: 12 months
Change of Quality of life assessment (EQ-5D)
Time frame: 12 months
Incidence of adverse events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month clinical glycemic control rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.