A open label, randomized, controled trial to assess the utility of Pitavastatin for patients with type2 diabetes and obesity in Matsuyama Shimin Hospital.

A open label, randomized, controled trial to assess the utility of Pitavastatin for patients with type2 diabetes and obesity in Matsuyama Shimin Hospital. - Utility of Pitavastatin for patients with type2 diabetes and obesity in Matsuyama Shimin Hospital(POM study).

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007024

Enrollment

Registered

2012-01-06

Start date

2012-01-01

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 diabetic patients with hyperlipidemia

Interventions

(Pitavastatin group) Patients under treatment with pitavastatin (2mg/day) are switched from atrovastatin (10mg/day) to pitavastatin at the dose of 2mg/day for 6months. (Atrovastatin group) Patie

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who have been under treatment with atrovastatin for hyperlipidemia for more than 3 months. 2) Patients with type 2 diabetes mellitus. 3) Patients with HbA1c level 6.5-7.9%. 4) Patients with BMI level 25 or more.

Exclusion criteria

Exclusion criteria: 1) Patients with insulin. 2) Patients requiring hospitalization to attain glycemic control. 3) Patients who have hypersensitivity to LIVALO tablet. 4) Patients who have severe liver dysfunction or biliary atresia. 5)Patients who are being treated with cyclosporine. 6) Pregnant women, women suspected of being pregnant, or lactating women. 7) Patients judged inadequate to participate in this study by their physician.

Design outcomes

Primary

Measure	Time frame
change about HbA1c	—

Secondary

Measure	Time frame
1)change in following laboratory data 1.fasting Glucose 2.HOMA-IR 3.adiponectin 4.hs-CRP 5.visceral fat,hepatic CT 6.AST,ALT 7.serum lipids (TC,LDL-C,HDL-C,TG) 8.Apoprotein (ApoA-1,ApoB,ApoE) 2) Relationship of following laboratory data 1. Relationship of change about HbA1c and change about each laboratory data 2. Relationship BMI and change about each laboratory data 3. Relationship of change about serum lipids(LDL-C,HDL-C,TG),Apoprotein(ApoA-1,ApoB,ApoE)and change about each laboratory data 4. Relationship of change about ALT,AST and change about each laboratory data 5. Relationship of change about visceral fat,hepatic CT and change about each laboratory data	—

Measure

Time frame

1)change in following laboratory data 1.fasting Glucose 2.HOMA-IR 3.adiponectin 4.hs-CRP 5.visceral fat,hepatic CT 6.AST,ALT 7.serum lipids (TC,LDL-C,HDL-C,TG) 8.Apoprotein (ApoA-1,ApoB,ApoE) 2) Relationship of following laboratory data 1. Relationship of change about HbA1c and change about each laboratory data 2. Relationship BMI and change about each laboratory data 3. Relationship of change about serum lipids(LDL-C,HDL-C,TG),Apoprotein(ApoA-1,ApoB,ApoE)and change about each laboratory data 4. Relationship of change about ALT,AST and change about each laboratory data 5. Relationship of change about visceral fat,hepatic CT and change about each laboratory data

—

Countries

Japan

Contacts

Public ContactTETSUJI NIIYA

MATSUYAMA SHIMIN HOSPITAL Internal medicine

t.niiya@matsuyama-shimin-hsp.or.jp089-943-1151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026