Type 2 Diabetes Mellitus (T2DM)Phase 4NCT07442006
Glycemic Variability of Combination Therapies in T2DM
A Phase 4 study testing Empagliflozin/Metformin, Anagliptin and Metformin in people with Type 2 Diabetes Mellitus (T2DM), run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
Glycemic Variability of Combination Therapies in T2DM Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Empagliflozin/Metformin, Anagliptin and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Oct 2025to 31 Mar 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
- Inadequate glycemic control despite treatment with Metformin (≥ 1,000mg/day) and SGLT-2 inhibitor.
Who cannot join
- History of acute or chronic metabolic acidosis
- Moderate to severe renal impairment (eGFR < 45 mL/min/1.73m²)
- Severe hepatic impairment
- History of heart failure (NYHA Class III/IV)
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, 1 recruiting
- Recruiting
The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator
Seoul
Sung Rae Kim, 82-32-340-7013, kimsungrae@catholic.ac.kr
About this study
Official title: A Multicenter Study to Evaluate Efficacy and Safety
Glycemic Variability of Combination Therapies in T2DM
Read the detailed description
A multicenter study to evaluate efficacy and safety
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Empagliflozin/Metformin, Anagliptin, Metformin, Empagliflozin/Linagliptin
- Keywords
- Glycemic Variability
- 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/MetforminDrug
5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
AnagliptinDrug
100 mg, for 12 weeks (PO, BID)
MetforminDrug
500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
Empagliflozin/LinagliptinDrug
10/5 mg, for 12 weeks (PO, QD)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Empagliflozin/Metformin + Anagliptin Receives: Drug: Empagliflozin/Metformin; Drug: Anagliptin |
| Active Comparator | Active comparator | Metformin + Empagliflozin/Linagliptin Receives: Drug: Metformin; Drug: Empagliflozin/Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12
Measured: Baseline to week 12
Secondary outcomes (6)
Change in the percentage of time spent within the target glucose range (70-180 mg/dL)
Measured: Baseline to week 12
Change from baseline in mean blood glucose at 12 weeks
Measured: Baseline to week 12
Change from baseline in HbA1c at 12 weeks
Measured: Baseline to week 12
Change from baseline in FPG at 12 weeks
Measured: Baseline to week 12
Change from baseline in HOMA-β at 12 weeks
HOMA- β: 20*fasting insulin/[(fasting plasma glucose*0.0555)-3.5]
Measured: Baseline to week 12
Change from baseline in HOMA-IR at 12 weeks
HOMA-IR: fasting insulin*(fasting glucose*0.0555)/22.5
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start29 Oct 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- 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
- Model description
- randomized, open-label, active-controlled, parallel, phase IV
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung Rae Kim, Principal investigator, The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442006
- Sponsor's protocol ID
- JW25402
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 2 Mar 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07442006
- Acronym / sponsor ID
- JW25402
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Glycemic Variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Mar 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.
Glycemic Variability of Combination Therapies in T2DM
Detailed description
A multicenter study to evaluate efficacy and safety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, open-label, active-controlled, parallel, phase IV
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Empagliflozin/Metformin, Drug: AnagliptinEmpagliflozin/Metformin + Anagliptin |
| Active Comparator | Active comparator | Drug: Metformin, Drug: Empagliflozin/LinagliptinMetformin + Empagliflozin/Linagliptin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inadequate glycemic control despite treatment with Metformin (≥ 1,000mg/day) and SGLT-2 inhibitor.
Key exclusion criteria (4 listed)
- History of acute or chronic metabolic acidosis
- Moderate to severe renal impairment (eGFR < 45 mL/min/1.73m²)
- Severe hepatic impairment
- History of heart failure (NYHA Class III/IV)
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/Metformin5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID) | Drug | Experimental |
| Anagliptin100 mg, for 12 weeks (PO, BID) | Drug | Experimental |
| Metformin500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID) | Drug | Active Comparator |
| Empagliflozin/Linagliptin10/5 mg, for 12 weeks (PO, QD) | Drug | Active Comparator |
Primary outcome
Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12
Time frame: Baseline to week 12
6 secondary outcomes
Change in the percentage of time spent within the target glucose range (70-180 mg/dL)
Time frame: Baseline to week 12
Change from baseline in mean blood glucose at 12 weeks
Time frame: Baseline to week 12
Change from baseline in HbA1c at 12 weeks
Time frame: Baseline to week 12
Change from baseline in FPG at 12 weeks
Time frame: Baseline to week 12
Change from baseline in HOMA-β at 12 weeks
Time frame: Baseline to week 12
Change from baseline in HOMA-IR at 12 weeks
Time frame: Baseline to week 12
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 2 Mar 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.
Sung Rae Kim principal investigator
The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator
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/Metformin, Anagliptin and Metformin in people with Type 2 Diabetes Mellitus (T2DM), run by JW 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Mar 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 Saemi Kang (82-2-840-6902, kangsm@jwhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12 (time frame: Baseline to week 12). 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 2 Mar 2026.