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

Primary Purpose

Hypercholesterolemia With Type2DM

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Pitavastatin

Atorvastatin

About this trial

This is an interventional treatment trial for Hypercholesterolemia With Type2DM focused on measuring pitavastatin, PWV, ESPRIT, Pitavastatin and Atorvastatin, Adiponectin, fasting insulin, hs-CRP, baPWV

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pitavastatin Group

Atorvastatin Group

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Patients Achieving LDL- C<100mg/dL

compare the proportion of patients achieving LDL- C<100mg/dL

Secondary Outcome Measures

The Change of LDL-C

The change of LDL-C between at 16-week and baseline

Full Information

NCT ID

NCT00889226

First Posted

April 27, 2009

Last Updated

August 26, 2019

Sponsor

JW Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00889226

Brief Title

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

Acronym

ESPRIT

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

JW Pharmaceutical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia With Type2DM

Keywords

pitavastatin, PWV, ESPRIT, Pitavastatin and Atorvastatin, Adiponectin, fasting insulin, hs-CRP, baPWV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

161 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pitavastatin Group

Arm Type

Experimental

Arm Title

Atorvastatin Group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Pitavastatin

Other Intervention Name(s)

Livalo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Other Intervention Name(s)

Lipitor

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of Patients Achieving LDL- C<100mg/dL

Description

compare the proportion of patients achieving LDL- C<100mg/dL

Time Frame

After 16wk drug administration

Secondary Outcome Measure Information:

Title

The Change of LDL-C

Description

The change of LDL-C between at 16-week and baseline

Time Frame

After 16wk drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ho Young Shon, MD

Organizational Affiliation

Endocrinology, Kangnam Saint Mary's Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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