Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

• Sponsor: Kowa Research Europe (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00344370
• Collaborator: (none)
• Enrollment: 214
• Locations: 35
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes Mellitus; Dyslipidemia	Drug: Pitavastatin; Drug: Atorvastatin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 214 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-Blind, Follow-On Study of Pitavastatin (4 mg) Versus Atorvastatin (20 mg and 40 mg), With a Single-Blind Extension of Treatment, in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pitavastatin Pitavastatin 4 mg QD	Drug: Pitavastatin; Pitavastatin 4 mg QD; Other Names: Livalo
Active Comparator: Atorvastatin Atorvastatin 40 mg	Drug: Atorvastatin; Atorvastatin 40 mg; Other Names: Lipitor

Outcome Measures

Primary Outcome Measures

1. NCEP LDL-C Target Attainment [44 weeks]

   Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.

Secondary Outcome Measures

1. Percent Change From Baseline in LDL-C [Basseline to 44 weeks]

   Percent change from baseline in LDL-C at 44 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type II diabetes mellitus

• Combined dyslipidemia

• Completed NK-104-305 (NCT00309751)

Exclusion Criteria:

• Withdrawal from NK-104-305 (NCT00309751)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCBR Aalborg	Aalborg		Denmark
2	CCBR A/S	Vejle		Denmark
3	CCBR Vejle	Vejle		Denmark
4	Gemeinschaftspraxis am Bahnhof	Berlin-Spandau		Germany
5	Pharmakologisches Studienzentum Chemnitz	Chemnitz		Germany
6	Internistische Diabetische Schwerpunktpraxis Dr.	Frankfurt Am Main		Germany
7	Internistische Gemeinschaftspraxis	Mainz		Germany
8	Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler	Messkirch		Germany
9	Bhagwan Mahaveer Jain Heart Centre	Bangalore		India
10	Sri Ramachandra Medical College Hospital	Chennai		India
11	Apollo Hospitals	Hyderabaad		India
12	CARE Group of Hospitals	Hyderabaad		India
13	PD Hinduja Hospital	Mumbai		India
14	Andromed Breda	Breda		Netherlands
15	Andromed Eindhoven	Eindhoven		Netherlands
16	Andromed Noord	Groningen		Netherlands
17	Andromed Leiden	Leiden		Netherlands
18	Andromed Nijmegen	Nijmegen		Netherlands
19	Andromed Rotterdam	Rotterdam		Netherlands
20	Andromed Oost	Velp		Netherlands
21	Andromed Zoetermeer	Zoetermeer		Netherlands
22	Podlaski Osrodek Kardiologii	Bialystok		Poland
23	NZOZ GCP Dobra Praktyka Lekaska	Gruziadz		Poland
24	NZOZ Terapia Optima	Katowice		Poland
25	NZOZ Esculap, Przychodnia Lekary Rodzinnych	Losice		Poland
26	NZOZ Centrum, Poradnia Kardiologiczna	Siedlce		Poland
27	Spec. Gab. Lek. Internistyczno-Kardiologicznly	Tarnow		Poland
28	Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego	Tychy		Poland
29	Instytut Zywnosci i Zywienia	Warszawa		Poland
30	Lecznica PROSEN SMO	Warszawa		Poland
31	Szpital Wolski,im. Dr A. Gostynskiej	Warszawa		Poland
32	Synexus Reading Clinical Research Centre	Berkshire		United Kingdom
33	Synexus Lancashire Clinical Research Centre	Lancashire		United Kingdom
34	Synexus Merseyside Clinical Research Centre	Liverpool		United Kingdom
35	Synexus Manchester Clinical Research Centre	Manchester		United Kingdom

Sponsors and Collaborators

• Kowa Research Europe

Investigators

• Study Director: Dragos Budinski, MD, Kowa Research Europe (KRE)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00344370
• Other Study ID Numbers: NK-104-310
• First Posted: Jun 26, 2006
• Last Update Posted: Feb 2, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: Pitavastatin; Type II Diabetes Mellitus; Combined Dyslipidemia
• Additional relevant MeSH terms: Diabetes Mellitus; Dyslipidemias; Diabetes Mellitus, Type 2; Atorvastatin; Pitavastatin

Study Results

Participant Flow

Arm/Group Title	Pitavastatin 4 mg	Atorvastatin 40 mg
Arm/Group Description	Pitavastatin 4 mg once daily	Atorvastatin 40 mg once daily
Period Title: Overall Study
STARTED	143	71
COMPLETED	128	68
NOT COMPLETED	15	3

Baseline Characteristics

Arm/Group Title	Pitavastatin 4 mg	Atorvastatin 40 mg	Total
Arm/Group Description	Pitavastatin 4 mg once daily	Atorvastatin 40 mg once daily	Total of all reporting groups
Overall Participants	143	71	214
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	95 66.4%	46 64.8%	141 65.9%
>=65 years	48 33.6%	25 35.2%	73 34.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.3 (9.83)	60.0 (9.21)	59.5 (9.61)
Sex: Female, Male (Count of Participants)
Female	68 47.6%	30 42.3%	98 45.8%
Male	75 52.4%	41 57.7%	116 54.2%

Outcome Measures

1. Primary Outcome

Title	NCEP LDL-C Target Attainment
Description	Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.
Time Frame	44 weeks

Outcome Measure Data

Analysis Population Description

The efficacy population is defined as all patients who received at least one dose of study drug and who had at least one on-treatment lipid assessment

Arm/Group Title	Pitavastatin 4 mg	Atorvastatin 40 mg
Arm/Group Description	Pitavastatin 4 mg once daily	Atorvastatin 40 mg once daily
Measure Participants	141	71
Number [Participants]	110 76.9%	55 77.5%

2. Secondary Outcome

Title	Percent Change From Baseline in LDL-C
Description	Percent change from baseline in LDL-C at 44 weeks
Time Frame	Basseline to 44 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin 4 mg	Atorvastatin 40 mg
Arm/Group Description	Pitavastatin 4 mg once daily	Atorvastatin 40 mg once daily
Measure Participants	141	71
Mean (Standard Deviation) [percent change]	-40.98 (19.053)	-41.43 (21.159)

Adverse Events

Arm/Group Title	Pitavastatin 4 mg		Atorvastatin 40 mg
Arm/Group Description	Pitavastatin 4 mg once daily		Atorvastatin 40 mg once daily
All Cause Mortality
	Pitavastatin 4 mg		Atorvastatin 40 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pitavastatin 4 mg		Atorvastatin 40 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/143 (5.6%)		5/71 (7%)
Cardiac disorders
Acute coronary syndrome	1/143 (0.7%)		1/71 (1.4%)
Angina pectoris	1/143 (0.7%)		0/71 (0%)
Cardiomyopathy	1/143 (0.7%)		0/71 (0%)
Myocardial infarction	1/143 (0.7%)		0/71 (0%)
Gastrointestinal disorders
Abdominal pain	0/143 (0%)		1/71 (1.4%)
Food poisoning	1/143 (0.7%)		0/71 (0%)
Gastrointestinal haemorrhage	1/143 (0.7%)		0/71 (0%)
Umbilical hernia, obstructive	1/143 (0.7%)		0/71 (0%)
Infections and infestations
Abdominal wall abscess	1/143 (0.7%)		0/71 (0%)
Bacterial pyelonephritis	0/143 (0%)		1/71 (1.4%)
Urosepsis	0/143 (0%)		1/71 (1.4%)
Injury, poisoning and procedural complications
Rib fracture	1/143 (0.7%)		0/71 (0%)
Traumatic brain injury	1/143 (0.7%)		0/71 (0%)
Investigations
Transaminases increased	1/143 (0.7%)		0/71 (0%)
Musculoskeletal and connective tissue disorders
Myalgia intercostal	0/143 (0%)		1/71 (1.4%)
Nervous system disorders
Epilepsy	0/143 (0%)		1/71 (1.4%)
Ischaemic stroke	1/143 (0.7%)		0/71 (0%)
Renal and urinary disorders
Nephrolithiasis	1/143 (0.7%)		0/71 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/143 (0.7%)		0/71 (0%)
Other (Not Including Serious) Adverse Events
	Pitavastatin 4 mg		Atorvastatin 40 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/143 (15.4%)		15/71 (21.1%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	2/143 (1.4%)		4/71 (5.6%)
Musculoskeletal and connective tissue disorders
Myalgia/myalgia intercostal	6/143 (4.2%)		5/71 (7%)
Naspopharyngitis	10/143 (7%)		2/71 (2.8%)
Vascular disorders
Arteriosclerosis	4/143 (2.8%)		4/71 (5.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.