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NCT Number: NCT07365358

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

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

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Key information

Conditions

Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

empagliflozin 10mg

Drug

once a day for 24 weeks

Other names: Empamax 10mg

Glimepiride 1mg

Drug

once a day for 24 weeks

Other names: Amaryl 1mg

Primary outcomes

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

    Time frame: Baseline and Week 24

    • No hypoglycemic events(<70mg/dL) for 24 weeks
    • No weight change at 24 week
    • HbA1c <7.0% at 24 week

Secondary outcomes

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

    Time frame: Baseline and Week 12

    • No hypoglycemic events(<70mg/dL) for 12 weeks
    • No weight change at 12 week
    • HbA1c <7.0% at 12 week

  2. Change from baseline in HbA1c and FPG

    Time frame: Baseline and Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

In-Kyung Jeong, MD, PhD

CONTACT

[email protected]

+82-2-440-6126

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Acronym: EMPAGO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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