Type 2 DiabetesPhase 4NCT06399835
Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis
A Phase 4 study testing Enavogliflozin and Pioglitazone in people with Type 2 Diabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Enavogliflozin and Pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2024to 31 Dec 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients with a glycated hemoglobin (HbA1c) level of 7.0 - 10.5% at screening
- Males or females aged 20-80 years
- Individuals who have been taking Metformin (≥ 500mg) with or without a DPP-4 inhibitor (such as Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Gemigliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin) for at least the past 3 months
- Body mass index ≥ 23 kg/m²
- Estimated glomerular filtration ratio (eGFR) ≥ 60 ml/min/1.73m²
Who cannot join
- Patients with Type 1 Diabetes, Gestational Diabetes, or secondary diabetes due to other causes
- Patients with a history of acute cardiovascular disease within the last 3 months prior to the screening visit
- Pregnant or breastfeeding patients, or patients not using contraception. Patients with chronic Hepatitis B or C (excluding healthy carriers of Hepatitis B), or liver disease (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal)
- Patients with heart failure or a history of heart failure
- Individuals with a history of cancer within the past 5 years (excluding those adequately treated for squamous cell carcinoma or thyroid cancer)
- Patients who have participated in another clinical study within the last 30 days
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- Alcohol addiction
- Patients for whom the use of Enavogliflozin or Pioglitazone is contraindicated
- Patients taking other oral hypoglycemic agents or insulin or other investigational drugs
- Patients deemed unsuitable for the study based on the investigator's judgment
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
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Soo Lim, +82317877035 ext. 82317877035, limsoo@snu.ac.kr
Minji Sohn, +82317878443 ext. 82317878443, rainbowmjs@naver.com
About this study
Official title: Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes
The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.
- Conditions
- Type 2 Diabetes
- Being tested
- Enavogliflozin, Pioglitazone
- 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.
EnavogliflozinDrug
Also called Envlo Tab.
Enavogliflozin 0.3mg once daily
PioglitazoneDrug
Also called Actos Tab.
Pioglitazone 15mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Enavogliflozin | Experimental | Enavogliflozin 0.3 mg Receives: Drug: Enavogliflozin |
| Pioglitazone | Active comparator | Pioglitazone 15 mg Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of HbA1c from the baseline
%
Measured: 24 weeks
Secondary outcomes (13)
Patients achieving HbA1c levels below 7%
N and percentage of the patients
Measured: 24 weeks
Changes of body fat (whole body fat, abdominal fat)
kg, %; measured with bioelectrical impedance analysis
Measured: 24 weeks
Changes of body weight
Measured: 12 weeks, 24 weeks
Changes of glucose levels (fasting, 2-hour postprandial)
mg/dL
Measured: 12 weeks, 24 weeks
Changes of systolic/diastolic blood pressures
mmHg
Measured: 12 weeks, 24 weeks
Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides)
mg/dL
Measured: 12 weeks, 24 weeks
Changes of electrolytes (uric acid)
mg/dL
Measured: 12 weeks, 24 weeks
Changes in parathyroid hormone
pg/mL
Measured: 12 weeks, 24 weeks
Changes in 25-hydroxyl vitamin D3
ng/mL
Measured: 12 weeks, 24 weeks
Changes of albuminuria
mg/g
Measured: 12 weeks, 24 weeks
Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose)
mg/dL
Measured: 12 weeks, 24 weeks
Changes in ketone body
umol/L
Measured: 12 weeks, 24 weeks
Changes of carotid intima-media thickness
maximal thickness (mm)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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 DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, M.D. Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399835
- Sponsor's protocol ID
- B-2310-859-002
- Status last verified
- May 2026
- First submitted
- 26 Apr 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06399835
- Acronym / sponsor ID
- B-2310-859-002
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 May 2024 (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 current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enavogliflozin | Experimental | Drug: EnavogliflozinEnavogliflozin 0.3 mg |
| Pioglitazone | Active comparator | Drug: PioglitazonePioglitazone 15 mg |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes patients with a glycated hemoglobin (HbA1c) level of 7.0 - 10.5% at screening
- Males or females aged 20-80 years
- Individuals who have been taking Metformin (≥ 500mg) with or without a DPP-4 inhibitor (such as Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Gemigliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin) for at least the past 3 months
- Body mass index ≥ 23 kg/m²
- Estimated glomerular filtration ratio (eGFR) ≥ 60 ml/min/1.73m²
Key exclusion criteria (10 listed)
- Patients with Type 1 Diabetes, Gestational Diabetes, or secondary diabetes due to other causes
- Patients with a history of acute cardiovascular disease within the last 3 months prior to the screening visit
- Pregnant or breastfeeding patients, or patients not using contraception. Patients with chronic Hepatitis B or C (excluding healthy carriers of Hepatitis B), or liver disease (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal)
- Patients with heart failure or a history of heart failure
- Individuals with a history of cancer within the past 5 years (excluding those adequately treated for squamous cell carcinoma or thyroid cancer)
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 |
|---|---|---|
| EnavogliflozinAlso: Envlo Tab.Enavogliflozin 0.3mg once daily | Drug | Enavogliflozin |
| PioglitazoneAlso: Actos Tab.Pioglitazone 15mg once daily | Drug | Pioglitazone |
Primary outcome
Changes of HbA1c from the baseline
Time frame: 24 weeks
%
13 secondary outcomes
Patients achieving HbA1c levels below 7%
Time frame: 24 weeks
Changes of body fat (whole body fat, abdominal fat)
Time frame: 24 weeks
Changes of body weight
Time frame: 12 weeks, 24 weeks
Changes of glucose levels (fasting, 2-hour postprandial)
Time frame: 12 weeks, 24 weeks
Changes of systolic/diastolic blood pressures
Time frame: 12 weeks, 24 weeks
Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides)
Time frame: 12 weeks, 24 weeks
Changes of electrolytes (uric acid)
Time frame: 12 weeks, 24 weeks
Changes in parathyroid hormone
Time frame: 12 weeks, 24 weeks
Changes in 25-hydroxyl vitamin D3
Time frame: 12 weeks, 24 weeks
Changes of albuminuria
Time frame: 12 weeks, 24 weeks
Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose)
Time frame: 12 weeks, 24 weeks
Changes in ketone body
Time frame: 12 weeks, 24 weeks
Changes of carotid intima-media thickness
Time frame: 24 weeks
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 5 May 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.
Soo Lim, M.D. Ph.D. principal investigator
Seoul National University Bundang Hospital
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 Enavogliflozin and Pioglitazone in people with Type 2 Diabetes, run by Seoul National University Bundang Hospital 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 5 inclusion and 10 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 5 May 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 Soo Lim, M.D. Ph.D. (+82317877035, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of HbA1c from the baseline (time frame: 24 weeks). 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 5 May 2026.