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

NCT ID: NCT07003191

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-02

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Liaoning Health Industry Group Fushun Mining General Hospital

UNKNOWN

Sponsor Role collaborator

Liaoning Health Industry Group Benxi Steel General Hospital

UNKNOWN

Sponsor Role collaborator

Changsha Fourth Hospital

OTHER_GOV

Sponsor Role collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

The First People's Hospital of Kunshan

OTHER

Sponsor Role collaborator

Suzhou Ninth People's Hospital

UNKNOWN

Sponsor Role collaborator

the First Affiliated Hospital of Anhui University of Science and Technology

UNKNOWN

Sponsor Role collaborator

Mingguang People's Hospital

UNKNOWN

Sponsor Role collaborator

the People's Hospital Longhua Shenzhen

UNKNOWN

Sponsor Role collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

Sponsor Role collaborator

Yiyang County People's Hospital

UNKNOWN

Sponsor Role collaborator

THE SECOND PEOPLE'S HOSPITAL, WUHU

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Zhangjiagang

UNKNOWN

Sponsor Role collaborator

Yixing People's Hospital

OTHER

Sponsor Role collaborator

Shijiazhuang People's Hospital

OTHER

Sponsor Role collaborator

Guiyang First People's Hospital

UNKNOWN

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

Tiefa Coal Industry Group General Hospital

UNKNOWN

Sponsor Role collaborator

Southern Medical University Shenzhen Hospital

UNKNOWN

Sponsor Role collaborator

The Second Hospital of Shijiazhuang

UNKNOWN

Sponsor Role collaborator

Ningbo University Affiliated People's Hospital

UNKNOWN

Sponsor Role collaborator

Dongyang People's Hospital

OTHER

Sponsor Role collaborator

Xiangyang Central Hospital

OTHER

Sponsor Role collaborator

Li Hui Li Hospital

UNKNOWN

Sponsor Role collaborator

Nanning Second People's Hospital

OTHER

Sponsor Role collaborator

Hunan Provincial People's Hospital Ma Wang Dui Branch

UNKNOWN

Sponsor Role collaborator

The Second Affiliated Hospital of Bengbu Medical College

UNKNOWN

Sponsor Role collaborator

Ruyang County People's Hospital

UNKNOWN

Sponsor Role collaborator

Kaifeng People's Hospital

UNKNOWN

Sponsor Role collaborator

Dingzhou People's Hospital

UNKNOWN

Sponsor Role collaborator

The Second People's Hospital of Changshu

UNKNOWN

Sponsor Role collaborator

The Second Affiliated Hospital of Henan University of Science and Technology

UNKNOWN

Sponsor Role collaborator

Dengzhou People's Hospital

UNKNOWN

Sponsor Role collaborator

Taizhou First People's Hospital

OTHER

Sponsor Role collaborator

Red Cross Hospital, Hangzhou, China

OTHER

Sponsor Role collaborator

The First People's Hospital of Lin'an District

UNKNOWN

Sponsor Role collaborator

China Resources Wugang General Hospital

UNKNOWN

Sponsor Role collaborator

Yiwu Central Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Jiashan County

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Tongxiang City

UNKNOWN

Sponsor Role collaborator

Shaoxing Central Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Jiande City

UNKNOWN

Sponsor Role collaborator

Beilun District People's Hospital

UNKNOWN

Sponsor Role collaborator

Huantai County People's Hospital

UNKNOWN

Sponsor Role collaborator

Fifth Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Shaanxi University of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Zhangjiagang Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yanbing Li

the director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2023-414

Identifier Type: -

Identifier Source: org_study_id

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