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Clinical Trial Details

Trial ID: L4111
Source ID: NCT06399835
Associated Drug: Enavogliflozin
Title: Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Enavogliflozin|DRUG: Pioglitazone
Outcome Measures: Primary: Changes of HbA1c from the baseline, 24 weeks | Secondary: Patients achieving HbA1c levels below 7%, N and percentage of the patients, 24 weeks|Changes of body fat (whole body fat, abdominal fat), kg, %; measured with bioelectrical impedance analysis, 24 weeks|Changes of body weight, 12 weeks, 24 weeks|Changes of glucose levels (fasting, 2-hour postprandial), mg/dL, 12 weeks, 24 weeks|Changes of systolic/diastolic blood pressures, mmHg, 12 weeks, 24 weeks|Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides), mg/dL, 12 weeks, 24 weeks|Changes of electrolytes (uric acid), mg/dL, 12 weeks, 24 weeks|Changes in parathyroid hormone, pg/mL, 12 weeks, 24 weeks|Changes in 25-hydroxyl vitamin D3, ng/mL, 12 weeks, 24 weeks|Changes of albuminuria, mg/g, 12 weeks, 24 weeks|Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose), mg/dL, 12 weeks, 24 weeks|Changes in ketone body, umol/L, 12 weeks, 24 weeks|Changes of carotid intima-media thickness, maximal thickness (mm), 24 weeks
Sponsor/Collaborators: Sponsor: Seoul National University Bundang Hospital | Collaborators: Daewoong Pharmaceutical Co. LTD.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 120
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2026-12
Results First Posted:
Last Update Posted: 2024-05-06
Locations: Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 13620, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06399835