NIPH Clinical Trials Search

Effect of Pemafibrate on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes : A Randomized Controlled Trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 2 Diabetes with Hypertriglyceridemia
Date of first enrollment	27/04/2026
Target sample size	100
Countries of recruitment
Study type	Interventional
Intervention(s)	<Control Group(Standard Therapy Group)> Patients will continue their conventional standard therapy for 16 weeks after enrollment <Intervention Group (Pemafibrate Group)> In addition to the conventional standard therapy, patients will receive pemafibrate extended-release tablets (XR) or pemafibrate immediate-release tablets (IR) at a dose of 0.2 mg per day for 16 weeks after enrollment

Outcome(s)

Primary Outcome	Change in E/e' from week 0 in echocardiography (e': average of septal e' and lateral wall e')
Secondary Outcome	1 Change in early diastolic mitral annular velocity (e') from week 0 as measured by echocardiography 2 Change in global longitudinal strain (GLS) from week 0 as measured by echocardiography 3 Safety: Incidence of adverse events and serious adverse events

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 85age old
Gender	Both
Include criteria	1. Men and women aged 18 to 85 years at the time of obtaining informed consent 2. Patients who have had at least one laboratory test result meeting either of the following criteria within 16 weeks prior to obtaining informed consent: 1 Fasting triglycerides(TG)>=150 mg/dL, or 2 Non-fasting triglycerides(TG) >= 175 mg/dL 3. Patients who have been diagnosed with type 2 diabetes mellitus 4. Outpatients or patients capable of attending outpatient visits 5. Patients whose lipid-lowering agents and antidiabetic medications have not been changed within 12 weeks prior to obtaining informed consent 6. Patients who voluntarily provide written informed consent to participate in the study
Exclude criteria	1. Patients who have been administered pemafibrate or any other fibrate-class drugs within 16 weeks prior to obtaining informed consent 2. Patients with atrial fibrillation 3. Patients whose most recent laboratory test within 16 weeks prior to obtaining informed consent showed triglyceride (TG) levels exceeding 500 mg/dL, regardless of fasting status 4. Individuals with severe renal impairment (creatinine greater than 2.5 mg/dL or eGFR less than 30 mL/min/1.73 m2) 5.Patients with liver cirrhosis classified as Child-Pugh class B or C 6. Patients with cholelithiasis or biliary obstruction 7. Pregnant women or women who may be pregnant 8. Women who are planning to become pregnant during the study period 9. Patients currently receiving cyclosporine or rifampicin 10. Patients with a history of hypersensitivity to pemafibrate 11. Patients deemed unsuitable for participation in this study by the principal investigator or co-investigator for any other reason