A prospective, multicenter, observational study of the effects of SGLT2 inhibitors/ SPPARMalpha combination therapy on liver function in patients with type 2 diabetes and dyslipidemia

A prospective, multicenter, observational study of the effects of SGLT2 inhibitors/ SPPARMalpha combination therapy on liver function in patients with type 2 diabetes and dyslipidemia - PEMA2i

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043716

Enrollment

Registered

2021-08-01

Start date

2022-11-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes and dyslipidemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes and dyslipidemia who need SGLT2 inhibitors and pemafibrate 2. Patients who are older than 20 years old at the time of obtaining consent 3. Patients whose ALT within the last 3 months before consent is beyond the normal range 4. Patients who have given written consent for this study

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to SGLT2 inhibitors and/or pemafibrate 2. Patients receiving SGLT2 inhibitors and/or pemafibrate 3. Patients who judged unsuitable for this study by the investigator

Design outcomes

Primary

Measure	Time frame
Changes in ALT from baseline at 52 weeks post-treatment	—

Countries

Japan

Contacts

Public ContactHiroaki Ueno

University of Miyazaki Division of Hematology, Diabetes, and Endocrinology

intron@med.miyazaki-u.ac.jp0985-85-9121

Outcome results