Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

May 2, 2026 updated by: Soo Lim, Seoul National University Bundang Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enavogliflozin
Enavogliflozin 0.3 mg
Drug: Enavogliflozin
Enavogliflozin 0.3mg once daily
Other Names:
  • Envlo Tab.
Active Comparator: Pioglitazone
Pioglitazone 15 mg
Drug: Pioglitazone
Pioglitazone 15mg once daily
Other Names:
  • Actos Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of HbA1c from the baseline
Time Frame: 24 weeks
%
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients achieving HbA1c levels below 7%
Time Frame: 24 weeks
N and percentage of the patients
24 weeks
Changes of body fat (whole body fat, abdominal fat)
Time Frame: 24 weeks
kg, %; measured with bioelectrical impedance analysis
24 weeks
Changes of body weight
Time Frame: 12 weeks, 24 weeks
12 weeks, 24 weeks
Changes of glucose levels (fasting, 2-hour postprandial)
Time Frame: 12 weeks, 24 weeks
mg/dL
12 weeks, 24 weeks
Changes of systolic/diastolic blood pressures
Time Frame: 12 weeks, 24 weeks
mmHg
12 weeks, 24 weeks
Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides)
Time Frame: 12 weeks, 24 weeks
mg/dL
12 weeks, 24 weeks
Changes of electrolytes (uric acid)
Time Frame: 12 weeks, 24 weeks
mg/dL
12 weeks, 24 weeks
Changes in parathyroid hormone
Time Frame: 12 weeks, 24 weeks
pg/mL
12 weeks, 24 weeks
Changes in 25-hydroxyl vitamin D3
Time Frame: 12 weeks, 24 weeks
ng/mL
12 weeks, 24 weeks
Changes of albuminuria
Time Frame: 12 weeks, 24 weeks
mg/g
12 weeks, 24 weeks
Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose)
Time Frame: 12 weeks, 24 weeks
mg/dL
12 weeks, 24 weeks
Changes in ketone body
Time Frame: 12 weeks, 24 weeks
umol/L
12 weeks, 24 weeks
Changes of carotid intima-media thickness
Time Frame: 24 weeks
maximal thickness (mm)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

  • Principal Investigator: Soo Lim, M.D. Ph.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2310-859-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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