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

Study Overview
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Brief Summary
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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
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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 .

Official Title
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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

Conditions
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Hypercholesterolemia With Type2DM

Intervention / Treatment
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* Drug: Pitavastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin Group<br> | Drug: Pitavastatin<br>* Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks<br>* Other names: Livalo;|
| Active Comparator: Atorvastatin Group<br> | Drug: Atorvastatin<br>* Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks<br>* Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Achieving LDL- C<100mg/dL | compare the proportion of patients achieving LDL- C<100mg/dL | After 16wk drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of LDL-C | The change of LDL-C between at 16-week and baseline | After 16wk drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pitavastatin, PWV, ESPRIT, Pitavastatin and Atorvastatin, Adiponectin, fasting insulin, hs-CRP, baPWV