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

Hypercholesterolemia With Type2DM Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889226
• Other study ID #: CWP_PTV4_704
• Status: Completed
• Phase: Phase 4
• Start date: April 2008
• Est. completion date: January 2010

Study information

• Verified date: July 2019
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypercholesterolemia
• Hypercholesterolemia With Type2DM

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Achieving LDL- C<100mg/dL	compare the proportion of patients achieving LDL- C<100mg/dL	After 16wk drug administration
Secondary	The Change of LDL-C	The change of LDL-C between at 16-week and baseline	After 16wk drug administration