Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

NCT ID: NCT06399835

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enavogliflozin

Enavogliflozin 0.3 mg

Group Type EXPERIMENTAL

Enavogliflozin

Intervention Type DRUG

Enavogliflozin 0.3mg once daily

Pioglitazone

Pioglitazone 15 mg

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

Pioglitazone 15mg once daily

Interventions

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Enavogliflozin

Enavogliflozin 0.3mg once daily

Intervention Type DRUG

Pioglitazone

Pioglitazone 15mg once daily

Intervention Type DRUG

Other Intervention Names

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Envlo Tab. Actos Tab.

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo Lim, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soo Lim, M.D. Ph.D.

Role: CONTACT

+82317877035

Minji Sohn, Ph.D.

Role: CONTACT

+82317878443

Facility Contacts

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Soo Lim

Role: primary

+82317877035 ext. 82317877035

Minji Sohn

Role: backup

+82317878443 ext. 82317878443

Other Identifiers

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B-2310-859-002

Identifier Type: -

Identifier Source: org_study_id

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