Type 2 Diabetes with Hypertriglyceridemia
Conditions
Interventions
Patients will continue their conventional standard therapy for 16 weeks after enrollment
In addition to the conventional standard therapy, patients will receive pemafibrate extended-release tablets (
Sponsors
Ohta Yasuharu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in E/e' from week 0 in echocardiography (e': average of septal e' and lateral wall e') | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactYuko Nagao
Yamaguchi University
Outcome results
None listed