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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-01-31

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

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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 .

Conditions

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Hypercholesterolemia With Type2DM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pitavastatin Group

Group Type EXPERIMENTAL

Pitavastatin

Intervention Type DRUG

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

Atorvastatin Group

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

Interventions

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Pitavastatin

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

Intervention Type DRUG

Atorvastatin

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

Intervention Type DRUG

Other Intervention Names

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Livalo Lipitor

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No