Actively Recruiting

Phase 4
Age: 20Years - 80Years
All Genders
NCT06399835

Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

Led by Seoul National University Bundang Hospital · Updated on 2026-05-05

120

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

S

Seoul National University Bundang Hospital

Lead Sponsor

D

Daewoong Pharmaceutical Co. LTD.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 for at least the past 3 months
  • Body mass index ≥ 23 kg/m²
  • Estimated glomerular filtration ratio (eGFR) ≥ 60 ml/min/1.73m²
Not Eligible

You will not qualify if you...

  • 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 with AST and/or 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

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Research Team

S

Soo Lim, M.D. Ph.D.

CONTACT

M

Minji Sohn, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis | DecenTrialz