Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients

A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients Inadequately Controlled With Metformin and Sitagliptin

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07365358

Acronym

EMPAGO

Enrollment

200

Registered

2026-01-26

Start date

2026-03-01

Completion date

2027-08-01

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Type 2

Keywords

Diabete Type 2, Empagliflozin

Brief summary

The purpose of this study is to evaluate the efficacy and safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients

Detailed description

This study is a Multi-center, Randomized, Open-label, Active comparator-controlled, Phase 4 Clinical Trial to evaluate the efficacy and safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients

Interventions

DRUGempagliflozin 10mg

once a day for 24 weeks

DRUGGlimepiride 1mg

once a day for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Over 19 years old * Type 2 diabetes mellitus * Patient who has been taking oral hypoglycemic agents for over 8 weeks * Agreement with written informed consent

Exclusion criteria

* Type 1 diabetes mellitus or secondary diabetes mellitus * Patients with complications of severe diabetes such as proliferative diabetic retinopathy * Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption * Patients with abnormal laboratory test results according to the protocol * Continuous or non-continuous treatment with insulin for over 7 days within 12 weeks prior to screening * History of treatment with corticosteroids within 4 weeks prior to screening

Design outcomes

Primary

Measure	Time frame	Description
Percentage of subjects who meet 3 conditions at the same time	Baseline and Week 24	1. No hypoglycemic events(\<70mg/dL) for 24 weeks 2. No weight change at 24 week 3. HbA1c \<7.0% at 24 week

Secondary

Measure	Time frame	Description
Percentage of subjects who meet 3 conditions at the same time	Baseline and Week 12	1. No hypoglycemic events(\<70mg/dL) for 12 weeks 2. No weight change at 12 week 3. HbA1c \<7.0% at 12 week
Change from baseline in HbA1c and FPG	Baseline and Week 24	—

Countries

South Korea

Contacts

CONTACTIn-Kyung Jeong, MD, PhD

jik1016@naver.com+82-2-440-6126

PRINCIPAL_INVESTIGATORIn-Kyung Jeong, MD, PhD

Kyung Hee University Hospital at Gangdong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026