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

Phase 4

Completed

• Conditions: Hypercholesterolemia With Type2DM
• Interventions: Drug: Atorvastatin; Drug: Pitavastatin

• Registration Number: NCT00889226
• Lead Sponsor: JW Pharmaceutical

Brief Summary

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

Detailed 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 .

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-28
• Primary Completion: 2009-05
• Study Completion: 2010-01
• Status Verified: 2019-07
• Results First Submitted: 2019-07-10
• Results First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Results First Posted: 2019-09-17
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin Group	Atorvastatin	-
Pitavastatin Group	Pitavastatin	-

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Achieving LDL- C<100mg/dL	After 16wk drug administration	compare the proportion of patients achieving LDL- C\<100mg/dL

Secondary Outcome Measures

Name	Time	Method
The Change of LDL-C	After 16wk drug administration	The change of LDL-C between at 16-week and baseline