Diabete Type 2Phase 4EMPAGONCT07365358
Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients
A Phase 4 study testing empagliflozin 10mg and Glimepiride 1mg in people with Diabete Type 2, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- empagliflozin 10mg and Glimepiride 1mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Kyung Hee University Hospital at Gangdong
Seoul
In-Kyung Jeong, MD, PhD, +82-2-440-6126, jik1016@naver.com
About this study
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
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
- Conditions
- Diabete Type 2
- Being tested
- empagliflozin 10mg, Glimepiride 1mg
- Keywords
- Diabete Type 2, Empagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empagliflozin 10mgDrug
Also called Empamax 10mg
once a day for 24 weeks
Glimepiride 1mgDrug
Also called Amaryl 1mg
once a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Expermental group 1 | Experimental | Empamax® 10mg Receives: Drug: empagliflozin 10mg |
| Expermental group 2 | Active comparator | Amaryl® 1mg Receives: Drug: Glimepiride 1mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 24
Secondary outcomes (2)
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
Measured: Baseline and Week 12
Change from baseline in HbA1c and FPG
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Kyung Jeong, MD, PhD, Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365358
- Sponsor's protocol ID
- B91_02DM2502
- Acronym
- EMPAGO
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07365358
- Acronym / sponsor ID
- EMPAGO / B91_02DM2502
- Conditions
- Diabete Type 2
- Keywords
- Diabete Type 2, Empagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expermental group 1 | Experimental | Drug: empagliflozin 10mgEmpamax® 10mg |
| Expermental group 2 | Active comparator | Drug: Glimepiride 1mgAmaryl® 1mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| empagliflozin 10mgAlso: Empamax 10mgonce a day for 24 weeks | Drug | Expermental group 1 |
| Glimepiride 1mgAlso: Amaryl 1mgonce a day for 24 weeks | Drug | Expermental group 2 |
Primary outcome
Percentage of subjects who meet 3 conditions at the same time
Time frame: 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
2 secondary outcomes
Percentage of subjects who meet 3 conditions at the same time
Time frame: Baseline and Week 12
Change from baseline in HbA1c and FPG
Time frame: Baseline and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
In-Kyung Jeong, MD, PhD principal investigator
Kyung Hee University Hospital at Gangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing empagliflozin 10mg and Glimepiride 1mg in people with Diabete Type 2, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact In-Kyung Jeong, MD, PhD (+82-2-440-6126, jik1016@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who meet 3 conditions at the same time (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.