to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia
Condition: HbA1c Level Associated With Lipid Compositions
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective

      : To evaluate that there is no different effect on HbA1c between routine lipid lowering
      therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic
      patients with impaired fasting glucose (IFG).

      H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4

      µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the
      control drug (Pitavastatin 2 MG)
    

Detailed description: 
      Investigational Product Test group: Pitavastatin calcium (LIVALO) 4mg tab Control group:
      Pitavastatin calcium (LIVALO) 2mg tab

      Study Site: Multi-centers in Korea

      Period: For 24months after IRB approval at each site (Including 12months of subject
      enrollment period)

      Efficacy End points

      A. Primary end point The change of HbA1c before and after taking LIVALO

      B. Secondary end point

        1. Incidence of diabetes within 1year after registration (based; FPG ≥126mg/dL or to need
           taking diabetes medication)

        2. Incidence of major cardiovascular (TLR-MACE) events within 1 year after registration

        3. Incidence of total cardiovascular (TVR-MACE) events within 1 year after registration

        4. The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB)

        5. The changes of hs-CRP

        6. The changes of Adiponectin

        7. The change of blood glucose and Insulin levels FPG(Fasting Plasma Glucose) Fasting Serum
           Insulin HOMA IR [fasting insulin(µIU/mL) X fasting glucose(mg/dL)]/405 HOMA β [360 X
           fasting insulin(µIU/mL)]/[fasting glucose(mg/dL)-63]

      Statistical Methods

        1. Efficacy A. Primary efficacy endpoint analysis Describe statistics of basic about the
           HbA1c variation before and after taking LIVALO by groups. In order to verify
           noninferiority of test drug, check that upper limit of confidence interval of the
           one-sided 97.5% is less than 0.4% about difference of HbA1c variation between the
           control group and the test group, before and after taking LIVALO.

           B. Secondary efficacy endpoint analysis Continuous variables

           :Present the mean, standard deviation, minimum, and maximum values for TC, TG, LDL-C,
           HDL-C, Fasting serum insulin, Fasting plasma glucose and HOMA IR, HOMA β etc. by each
           visit and in each group. In comparison with intergroup, using two-sample t-test for
           normal distribution and using Wilcoxon rank sum test for non-normal distribution. Also
           In comparison with the same group, using paired t-test for normal distribution and using
           Wilcoxon signed rank test for non-normal distribution.

           Discrete variables

           : The number and percentage of the subjects for incidence of DM and cardiovascular event
           are described of each group and the ratio of the intergroup comparison use χ2-test or
           Fisher's exact test.

        2. Safety All the AEs and the ADRs which manifested more than once are described by the
           frequency and percentage of each group and use χ2-test or Fisher's exact test for
           intergroup comparison about the rate of AEs and ADRs Laboratory tests and vital signs
           are analyzed descriptive statistics quantity of each group, and in comparison with
           intergroup, use two-sample t-test for normal distribution and use Wilcoxon rank sum test
           for non-normal distribution. Also, In comparison with the same group, use paired t-test
           for normal distribution and use Wilcoxon signed rank test for non-normal distribution.

      Clinical laboratory test is analyzed the frequency and percentage of the outside normal range
      of subjects, and using χ2-test or Fisher's exact test with intergroup.
    

Intervention name(s): Pitavastatin calcium 4mg; Pitavastatin calcium 2mg
Intervention type(s): Drug; Drug
Intervention description(s): taking once a day; Taking once a day
Other intervention name(s): Pitavastatin calcium(LIVALO) 4mg; LIVALO 2mg
Intervention MeSH terms: Calcium, Dietary; Pitavastatin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Livalo, pitavastatin, hyperlipidemia, IFG