Evaluate the Efficacy and Safety of Empagliflozin or Glim... | NCT07365358

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

NCT07365358

Sponsor

Chong Kun Dang Pharmaceutical

Status

Not yet recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

200Estimated

Phase

Phase 4

Conditions

Diabete Type 2

Interventions

empagliflozin 10mg
Glimepiride 1mg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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 Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2026Estimated

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Jan 15, 2026

First Submission Date that Met QC Criteria

Jan 22, 2026

First Posted Date

Jan 26, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Expermental group 1	Experimental	Empamax® 10mg	Drug: empagliflozin 10mg
Expermental group 2	Active Comparator	Amaryl® 1mg	Drug: Glimepiride 1mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
empagliflozin 10mg	Drug	once a day for 24 weeks	Expermental group 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
In-Kyung Jeong, MD, PhD	Contact	+82-2-440-6126		jik1016@naver.com

Overall Officials

Name	Affiliation	Role
In-Kyung Jeong, MD, PhD	Kyung Hee University Hospital at Gangdong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyung Hee University Hospital at Gangdong		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C570240	empagliflozin
C057619	glimepiride

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided