Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome

the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02940366

Enrollment

500

Registered

2016-10-20

Start date

2016-12-01

Completion date

2019-11-30

Last updated

2017-02-09

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

Conditions

Metabolic Syndrome

Brief summary

This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome.

Interventions

DRUGPitavastatin 4 mg orally daily

Pitavastatin 4 mg orally daily for 24months

DRUGAtorvastatin 20 mg orally daily

Atorvastatin 20 mg orally daily for 24months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients diagnosed as metabolic syndrome according to National cholesterol Education Program criteria * Patients with hypercholesterolemia who required to start statin therapy

Exclusion criteria

* overt diabetes * acute coronary syndrome within 2 months * acute cerebrovascular event within 2 months * recent treatment of statin within 1month * recent diagnosed neoplasm * recent diagnosed liver disease * chronic kidney disease * patients with myopathy * pregnant women, nursing mothers, women with possibility of pregnant * patients being adminstered cyclosporine * patients with genetic disease such as galactose intolerance, lactose intolerance, glucose-galactose malabsorption * patients with treatment cyclosporin

Design outcomes

Primary

Measure	Time frame
Absolute change in HbA1c level	baselina and after 24months treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026