Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

NCT06399835 | Recruiting Phase 4 DMC

• 1 other identifier: B-2310-859-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Changes of HbA1c from the baseline

  %

  24 weeks

Secondary Outcomes (13)

• Patients achieving HbA1c levels below 7%

  24 weeks

• Changes of body fat (whole body fat, abdominal fat)

  24 weeks

• Changes of body weight

  12 weeks, 24 weeks

• Changes of glucose levels (fasting, 2-hour postprandial)

  12 weeks, 24 weeks

• Changes of systolic/diastolic blood pressures

  12 weeks, 24 weeks

Study Arms (2)

Enavogliflozin

EXPERIMENTAL

Enavogliflozin 0.3 mg

Drug: Enavogliflozin

Pioglitazone

ACTIVE COMPARATOR

Pioglitazone 15 mg

Drug: Pioglitazone

Interventions

Enavogliflozin DRUG

Enavogliflozin 0.3mg once daily

Also known as: Envlo Tab.

Enavogliflozin

Pioglitazone DRUG

Pioglitazone 15mg once daily

Also known as: Actos Tab.

Pioglitazone

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

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

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Enavogliflozin; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Soo Lim, M.D. Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Lim, M.D. Ph.D.

CONTACT

+82317877035; limsoo@snu.ac.kr

Minji Sohn, Ph.D.

CONTACT

+82317878443; rainbowmjs@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 6, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)