NCT07365358

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
15mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress13%
Mar 2026Aug 2027

First Submitted

Initial submission to the registry

January 15, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 15, 2026

Last Update Submit

January 22, 2026

Conditions

Diabete Type 2

Keywords

Diabete Type 2Empagliflozin

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects who meet 3 conditions at the same time

    1. No hypoglycemic events(\<70mg/dL) for 24 weeks 2. No weight change at 24 week 3. HbA1c \<7.0% at 24 week

    Baseline and Week 24

Secondary Outcomes (2)

  • Percentage of subjects who meet 3 conditions at the same time

    Baseline and Week 12

  • Change from baseline in HbA1c and FPG

    Baseline and Week 24

Study Arms (2)

Expermental group 1

EXPERIMENTAL

Empamax® 10mg

Drug: empagliflozin 10mg

Expermental group 2

ACTIVE COMPARATOR

Amaryl® 1mg

Drug: Glimepiride 1mg

Interventions

empagliflozin 10mgDRUG

once a day for 24 weeks

Also known as: Empamax 10mg
Expermental group 1
Glimepiride 1mgDRUG

once a day for 24 weeks

Also known as: Amaryl 1mg
Expermental group 2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozinglimepiride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • In-Kyung Jeong, MD, PhD

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

In-Kyung Jeong, MD, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 26, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)