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
  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:


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
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 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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014