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Recruiting NCT06399835

Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

Phase IV Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enavogliflozin, Pioglitazone.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes

Overview

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.

Interventions

  • Drug Enavogliflozin
    Enavogliflozin 0.3mg once daily
  • Drug Pioglitazone
    Pioglitazone 15mg once daily

Primary outcome measures

  • Changes of HbA1c from the baseline [Time frame: 24 weeks]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Bundang Hospital — Seongnam-si

Identifiers

NCT: NCT06399835 · B-2310-859-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗