Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
JW Pharmaceutical Identifier:
First received: April 27, 2009
Last updated: April 2, 2013
Last verified: April 2013

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

Condition Intervention Phase
Hypercholesterolemia With Type2DM
Drug: Pitavastatin
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients achieving LDL- C<100mg/dL [ Time Frame: After 16wk drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of LDL-C, TC, TG, HDL-C, Apo A1, Apo B [ Time Frame: After 16wk drug administration ] [ Designated as safety issue: No ]
  • The change of hs-CRP 3 [ Time Frame: After 16wk drug administration ] [ Designated as safety issue: No ]
  • The change of fasting insulin [ Time Frame: After 16wk drug administration ] [ Designated as safety issue: No ]
  • The change of adiponectin [ Time Frame: After 16wk drug administration ] [ Designated as safety issue: No ]
  • The change of brachial ankle PWV [ Time Frame: After 16wk drug administration ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From enrollment to end of study ] [ Designated as safety issue: No ]
  • Any abnormal change of physical examination and Lab result [ Time Frame: From enrollment to end of study ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitavastatin Group Drug: 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
Other Name: Livalo
Active Comparator: Atorvastatin Group 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
Other Name: Lipitor

Detailed Description:

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 .


Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00889226

Sponsors and Collaborators
JW Pharmaceutical
Principal Investigator: Ho Young Shon, MD Endocrinology, Kangnam Saint Mary's Hospital
  More Information

No publications provided

Responsible Party: JW Pharmaceutical Identifier: NCT00889226     History of Changes
Other Study ID Numbers: CWP_PTV4_704
Study First Received: April 27, 2009
Last Updated: April 2, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by JW Pharmaceutical:
Pitavastatin and Atorvastatin
fasting insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2014