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

• Sponsor: JW Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00889226
• Collaborator: (none)
• Enrollment: 161
• Arms: 2
• Duration (Months): 21

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia With Type2DM	Drug: Pitavastatin; Drug: Atorvastatin	Phase 4

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 .

Study Design

• Study Type: Interventional
• Actual Enrollment: 161 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Lipitor

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients Achieving LDL- C<100mg/dL [After 16wk drug administration]

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

Secondary Outcome Measures

1. The Change of LDL-C [After 16wk drug administration]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• Sexes Eligible for Study: All
• 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

Locations

No locations specified.

Sponsors and Collaborators

• JW Pharmaceutical

Investigators

• Principal Investigator: Ho Young Shon, MD, Endocrinology, Kangnam Saint Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JW Pharmaceutical
• ClinicalTrials.gov Identifier: NCT00889226
• Other Study ID Numbers: CWP_PTV4_704
• First Posted: Apr 28, 2009
• Last Update Posted: Sep 17, 2019
• Last Verified: Jul 1, 2019

• 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; Atorvastatin; Pitavastatin

Study Results

Participant Flow

Arm/Group Title	Pitavastatin Group	Atorvastatin Group
Arm/Group Description	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
Period Title: Overall Study
STARTED	83	78
COMPLETED	58	43
NOT COMPLETED	25	35

Baseline Characteristics

Arm/Group Title	Pitavastatin Group	Atorvastatin Group	Total
Arm/Group Description	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	Total of all reporting groups
Overall Participants	83	78	161
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	59.6	59.1	59.3
Sex: Female, Male (Count of Participants)
Female	55 66.3%	54 69.2%	109 67.7%
Male	28 33.7%	24 30.8%	52 32.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
South Korea	83 100%	78 100%	161 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin Group	Atorvastatin Group
Arm/Group Description	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
Measure Participants	80	68
Count of Participants [Participants]	61 73.5%	54 69.2%

2. Secondary Outcome

Title	The Change of LDL-C
Description	The change of LDL-C between at 16-week and baseline
Time Frame	After 16wk drug administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin Group	Atorvastatin Group
Arm/Group Description	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
Measure Participants	80	68
Mean (Standard Deviation) [mg/dl]	-69.8 (22.5)	-70.9 (28.2)

Adverse Events

Time Frame	16 weeks
Arm/Group Title	Pitavastatin Group		Atorvastatin Group
Arm/Group Description	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
All Cause Mortality
	Pitavastatin Group		Atorvastatin Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/70 (0%)
Serious Adverse Events
	Pitavastatin Group		Atorvastatin Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Pitavastatin Group		Atorvastatin Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/81 (3.7%)		0/70 (0%)
Respiratory, thoracic and mediastinal disorders
coughing	3/81 (3.7%)	3	0/70 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.