NCT07003191

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

January 14, 2025

Last Update Submit

June 3, 2025

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 6-month clinical glycemic control rate

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

    6 months

Secondary Outcomes (9)

  • Change in HbA1c from baseline

    12 months

  • Change of β cell function

    12 months

  • Change of insulin sensitivity

    12 months

  • Change of lipid profiles

    12 months

  • Change of body weight

    12 months

  • +4 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatient and inpatient patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University

Study Record Dates

First Submitted

January 14, 2025

First Posted

June 4, 2025

Study Start

August 2, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations

CN(1)