to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia

HbA1c Level Associated With Lipid Compositions Clinical Trial

— SIPHON  

Official title:

Randomized, Open-label, Multi-centered Study to Evaluate the Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia(Phase 4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056847
• Other study ID #: JW-PTV-713
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2014
• Last updated: March 6, 2018
• Start date: September 2013
• Est. completion date: May 2017

Study information

• Verified date: March 2017
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male and Female patients who are more than 20 years old or 70 years old or less.

2. Patient who voluntarily sign on written informed consent form

3. Patient who LDL-C = 100mg/dl or was diagnosed with hyperlipidemia

4. Patient who was suspected with Imparied Fasting Glucose (IFG) and satisfy FPG level = 100mg/dL and < 126mg/dL when FPG measured twice.

Exclusion Criteria:

1. Patient who has familial hypercholesterolemia

2. Patient who has been diagnosed with Type1, Type2 DM or secondary DM(diabetes mellitus) at the screening visit (Diagnostic criteria of DM: HbA1c= 6.5%)

3. Patient who has received antidiabetic within 6weeks to the screening visit

4. Patient who has been taking insulin continuously or to be needed in the future

5. Patient who has a history of gastrectomy

6. Patient who is suspected or diagnosed with malignant tumor within last 10 years

7. Patient who has serious pancreatic disease or endocrine disorders

8. Patient who currently takes Cyclosporine

9. Patient who has a medical history of hypersensitivity to Pitavastatin calcium

10. Patient who has suspected renal failure (serum creatinine =2.0 mg/dL)

11. Patient who has suspected liver dysfunction (more than 2.5 times the upper limit of normal AST or ALT)

12. Patient who has more than 3 times the upper limit of normal CPK

13. Patient who is breastfeeding, pregnant or planning pregnancy

14. Patient who deemed inappropriate as subject in the opinion of the Principal Investigator or Investigator

Related Conditions & MeSH terms

• HbA1c Level Associated With Lipid Compositions
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Pitavastatin calcium 4mg
taking once a day
• Pitavastatin calcium 2mg
Taking once a day

Locations

Country	Name	City	State
Korea, Republic of	JW pharmaceutical	Seoul

Sponsors (19)

Lead Sponsor

Collaborator

JW Pharmaceutical

Ajou University School of Medicine, Asan Medical Center, Chonbuk National University Hospital, Chonnam National University Hospital, Chungnam National University Hospital, Dong-A University Hospital, Eulji University Hospital, Gangnam Severance Hospital, Hallym University Medical Center, Korea University Guro Hospital, Kyunghee University Medical Center, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Severance Hospital, The Catholic University of Korea, Ulsan University Hospital, Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of HbA1c before and after taking LIVALO®		24 weeks after taking IP
Secondary	Incidence of diabetes	based; FPG =126mg/dL or to need taking diabetes medication	within 1year after registration
Secondary	Incidence of total cardiovascular (TVR-MACE) events		within 1 year after registration
Secondary	The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB)		24weeks and 1 year after registration
Secondary	The changes of hs-CRP, Adiponectin, blood glucose and Insulin levels	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 ß [360 X fasting insulin(µIU/mL)]/[fasting glucose(mg/dL)-63]	24weeks and 1 year after registration