Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia (ESPRIT)

JW Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Hypercholesterolemia With Type2DM

Treatments

Drug: Atorvastatin

Drug: Pitavastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00889226

CWP_PTV4_704

Details and patient eligibility

About

A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia

Full description

To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .

Enrollment

161 patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: 25yrs~75yrs
Fasting TG <400mg/dL, LDL-C ≥130mg/dL
3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%

Exclusion criteria

Type1 DM, Gestational diabetes
Patient need to treat with Insulin
Patient with operational treatment for severe diabetic complication
Uncontrolled Hypothyroidism
Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
Renal disorder (Serum creatinine ≥ 2.0mg/dL)
Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
Creatinine Kinase > 2.5 X UNL
Gravida or lactation phase
Administration of Atorvastatin, Rosuvastatin, Pitavastatin