Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis
- Registration Number
- NCT06399835
- Lead Sponsor
- Seoul National University Bundang Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enavogliflozin Enavogliflozin Enavogliflozin 0.3 mg Pioglitazone Pioglitazone Pioglitazone 15 mg
- Primary Outcome Measures
Name Time Method Changes of HbA1c from the baseline 24 weeks
- Secondary Outcome Measures
Name Time Method Changes of albuminuria 12 weeks, 24 weeks mg/g
Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose) 12 weeks, 24 weeks mg/dL
Patients achieving HbA1c levels below 7% 24 weeks N and percentage of the patients
Changes of body fat (whole body fat, abdominal fat) 24 weeks kg, %; measured with bioelectrical impedance analysis
Changes of body weight 12 weeks, 24 weeks Changes of glucose levels (fasting, 2-hour postprandial) 12 weeks, 24 weeks mg/dL
Changes of systolic/diastolic blood pressures 12 weeks, 24 weeks mmHg
Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides) 12 weeks, 24 weeks mg/dL
Changes of electrolytes (uric acid) 12 weeks, 24 weeks mg/dL
Changes in parathyroid hormone 12 weeks, 24 weeks pg/mL
Changes in 25-hydroxyl vitamin D3 12 weeks, 24 weeks ng/mL
Changes of carotid intima-media thickness 24 weeks maximal thickness (mm)
Changes in ketone body 12 weeks, 24 weeks umol/L
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of