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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00889226
First received: April 27, 2009
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 .

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889226

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

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov 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
PWV
ESPRIT
Pitavastatin and Atorvastatin
 Adiponectin
fasting insulin
hs-CRP
baPWV

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Atorvastatin
 Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013