CompletedPhase 4

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

South Korea313 participantsStarted 2013-09

Plain-language 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)

Who can participate

Age range20 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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
✕. Patient who has serious pancreatic disease or endocrine disorders
✕. Patient who currently takes Cyclosporine

What they're measuring

The change of HbA1c before and after taking LIVALO®

Timeframe: 24 weeks after taking IP

Trial details

NCT IDNCT02056847

SponsorJW Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05

View on ClinicalTrials.gov More HbA1c Level Associated With Lipid Compositions trials