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Not yet recruitingNCT07365358EMPAGOUpdated Jan 26, 2026

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

A Phase 4 interventional study of empagliflozin 10mg and Glimepiride 1mg in Diabete Type 2, sponsored by Chong Kun Dang Pharmaceutical. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Diabete Type 2

Keywords

  • Diabete Type 2
  • Empagliflozin
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Expermental group 1

    Empamax® 10mg

    Drug: empagliflozin 10mg

  • Active comparator
    Expermental group 2

    Amaryl® 1mg

    Drug: Glimepiride 1mg

Interventions

  • Drugempagliflozin 10mg

    once a day for 24 weeks

    Also known as: Empamax 10mg

  • DrugGlimepiride 1mg

    once a day for 24 weeks

    Also known as: Amaryl 1mg

05

What researchers measure

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

    Time frame: Baseline and Week 24

Secondary outcomes

  1. Percentage of subjects who meet 3 conditions at the same time

    1. No hypoglycemic events(\<70mg/dL) for 12 weeks 2. No weight change at 12 week 3. HbA1c \<7.0% at 12 week

    Time frame: Baseline and Week 12

  2. Change from baseline in HbA1c and FPG

    Time frame: Baseline and Week 24

06

Study locations

1 site
  • Kyung Hee University Hospital at Gangdong
    Seoul, South Korea
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07365358
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Jan 26, 2026
Start date
Mar 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jan 26, 2026

Study contacts

In-Kyung Jeong, MD, PhD
Contact
jik1016@naver.com
+82-2-440-6126
In-Kyung Jeong, MD, PhD
principal investigator · Kyung Hee University Hospital at Gangdong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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