HbA1c Level Associated With Lipid CompositionsPhase 4SIPHONNCT02056847
to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia
A Phase 4 study testing Pitavastatin calcium 4mg and Pitavastatin calcium 2mg in people with HbA1c Level Associated With Lipid Compositions, run by JW Pharmaceutical at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- HbA1c Level Associated With Lipid Compositions
- What is being tested?
- Pitavastatin calcium 4mg and Pitavastatin calcium 2mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female patients who are more than 20 years old or 70 years old or less.
- Patient who voluntarily sign on written informed consent form
- Patient who LDL-C ≥ 100mg/dl or was diagnosed with hyperlipidemia
- Patient who was suspected with Imparied Fasting Glucose (IFG) and satisfy FPG level ≥ 100mg/dL and < 126mg/dL when FPG measured twice.
Who cannot join
- Patient who has familial hypercholesterolemia
- 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%)
- Patient who has received antidiabetic within 6weeks to the screening visit
- Patient who has been taking insulin continuously or to be needed in the future
- Patient who has a history of gastrectomy
- Patient who is suspected or diagnosed with malignant tumor within last 10 years
Show all 14Show fewer
- Patient who has serious pancreatic disease or endocrine disorders
- Patient who currently takes Cyclosporine
- Patient who has a medical history of hypersensitivity to Pitavastatin calcium
- Patient who has suspected renal failure (serum creatinine ≥2.0 mg/dL)
- Patient who has suspected liver dysfunction (more than 2.5 times the upper limit of normal AST or ALT)
- Patient who has more than 3 times the upper limit of normal CPK
- Patient who is breastfeeding, pregnant or planning pregnancy
- Patient who deemed inappropriate as subject in the opinion of the Principal Investigator or Investigator
Trial locations and contacts
1 site in 1 country.
About this study
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)
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)
Read the 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
- Primary end point The change of HbA1c before and after taking LIVALO
- Secondary end point
- Incidence of diabetes within 1year after registration (based; FPG ≥126mg/dL or to need taking diabetes medication)
- Incidence of major cardiovascular (TLR-MACE) events within 1 year after registration
- Incidence of total cardiovascular (TVR-MACE) events within 1 year after registration
- The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB)
- The changes of hs-CRP
- The changes of Adiponectin
- 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
- 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.
- 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.
- 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.
- Being tested
- Pitavastatin calcium 4mg, Pitavastatin calcium 2mg
- Keywords
- Livalo, pitavastatin, hyperlipidemia, IFG
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin calcium 4mgDrug
Also called Pitavastatin calcium(LIVALO) 4mg
taking once a day
Pitavastatin calcium 2mgDrug
Also called LIVALO 2mg
Taking once a day
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin calcium 4mg | Active comparator | Pitavastatin calcium (LIVALO®) 4mg, once a day Receives: Drug: Pitavastatin calcium 4mg |
| Pitavastatin calcium 2mg | Active comparator | Pitavastatin calcium (LIVALO®) 2mg, once a day Receives: Drug: Pitavastatin calcium 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of HbA1c before and after taking LIVALO®
Measured: 24 weeks after taking IP
Secondary outcomes (4)
Incidence of diabetes
based; FPG ≥126mg/dL or to need taking diabetes medication
Measured: within 1year after registration
Incidence of total cardiovascular (TVR-MACE) events
Measured: within 1 year after registration
The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB)
Measured: 24weeks and 1 year after registration
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 β [360 X fasting insulin(µIU/mL)]/[fasting glucose(mg/dL)-63]
Measured: 24weeks and 1 year after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startSep 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HbA1c Level Associated With Lipid CompositionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea, Kyunghee University Medical Center, Korea University Guro Hospital, Dong-A University Hospital, Seoul National University Bundang Hospital, Samsung Medical Center, Seoul National University Hospital, Ajou University School of Medicine, Gangnam Severance Hospital, Severance Hospital, Yeungnam University Hospital, Ulsan University Hospital, Eulji University Hospital, Asan Medical Center, Chonnam National University Hospital, Chonbuk National University Hospital, Chungnam National University Hospital, Hallym University Medical Center
- Responsible party
- Sponsor
- Investigators
- NamSik Chung, M.D., Ph D., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056847
- Sponsor's protocol ID
- JW-PTV-713
- Acronym
- SIPHON
- Status last verified
- Mar 2017
- First submitted
- 4 Feb 2014
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02056847
- Acronym / sponsor ID
- SIPHON / JW-PTV-713
- Keywords
- Livalo, pitavastatin, hyperlipidemia, IFG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea, Kyunghee University Medical Center, Korea University Guro Hospital, Dong-A University Hospital, Seoul National University Bundang Hospital, Samsung Medical Center, Seoul National University Hospital, Ajou University School of Medicine, Gangnam Severance Hospital, Severance Hospital, Yeungnam University Hospital, Ulsan University Hospital, Eulji University Hospital, Asan Medical Center, Chonnam National University Hospital, Chonbuk National University Hospital, Chungnam National University Hospital, Hallym University Medical Center
- Study start
- Sep 2013 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary end point The change of HbA1c before and after taking LIVALO
- Secondary end point
- Incidence of diabetes within 1year after registration (based; FPG ≥126mg/dL or to need taking diabetes medication)
- Incidence of major cardiovascular (TLR-MACE) events within 1 year after registration
- Incidence of total cardiovascular (TVR-MACE) events within 1 year after registration
- The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB)
- The changes of hs-CRP
- The changes of Adiponectin
- 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
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin calcium 4mg | Active comparator | Drug: Pitavastatin calcium 4mgPitavastatin calcium (LIVALO®) 4mg, once a day |
| Pitavastatin calcium 2mg | Active comparator | Drug: Pitavastatin calcium 2mgPitavastatin calcium (LIVALO®) 2mg, once a day |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and Female patients who are more than 20 years old or 70 years old or less.
- Patient who voluntarily sign on written informed consent form
- Patient who LDL-C ≥ 100mg/dl or was diagnosed with hyperlipidemia
- Patient who was suspected with Imparied Fasting Glucose (IFG) and satisfy FPG level ≥ 100mg/dL and < 126mg/dL when FPG measured twice.
Key exclusion criteria (14 listed)
- Patient who has familial hypercholesterolemia
- 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%)
- Patient who has received antidiabetic within 6weeks to the screening visit
- Patient who has been taking insulin continuously or to be needed in the future
- Patient who has a history of gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitavastatin calcium 4mgAlso: Pitavastatin calcium(LIVALO) 4mgtaking once a day | Drug | Pitavastatin calcium 4mg |
| Pitavastatin calcium 2mgAlso: LIVALO 2mgTaking once a day | Drug | Pitavastatin calcium 2mg |
Primary outcome
The change of HbA1c before and after taking LIVALO®
Time frame: 24 weeks after taking IP
4 secondary outcomes
Incidence of diabetes
Time frame: within 1year after registration
Incidence of total cardiovascular (TVR-MACE) events
Time frame: within 1 year after registration
The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB)
Time frame: 24weeks and 1 year after registration
The changes of hs-CRP, Adiponectin, blood glucose and Insulin levels
Time frame: 24weeks and 1 year after registration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NamSik Chung, M.D., Ph D. principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastatin calcium 4mg and Pitavastatin calcium 2mg in people with HbA1c Level Associated With Lipid Compositions, run by JW Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of HbA1c before and after taking LIVALO® (time frame: 24 weeks after taking IP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.