Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

Seoul National University

Status and phase: Enrolling; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Enavogliflozin; Drug: Pioglitazone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06399835

B-2310-859-002

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Enavogliflozin

Experimental group

Description:

Enavogliflozin 0.3 mg

Treatment:

Drug: Enavogliflozin

Pioglitazone

Active Comparator group

Description:

Pioglitazone 15 mg

Treatment:

Drug: Pioglitazone