Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

• Sponsor: Kowa Research Europe (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00309751
• Collaborator: (none)
• Enrollment: 418
• Locations: 35
• Arms: 2
• Duration (Months): 18
• Patients Per Site: 11.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 418 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pitavastatin 4 mg QD Pitavastatin 4 mg once daily	Drug: Pitavastatin; Pitavastatin 4 mg QD
Active Comparator: Atorvastatin 20 mg QD Atorvastatin 20 mg once daily	Drug: Atorvastatin; Atorvastatin 20 mg; Other Names: Lipitor

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) [12 weeks]

   Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures

1. Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target [12 weeks]

   Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males and females (ages 18-75 years)

• Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)

• Must have been following a restrictive diet

• Diagnosis of combined dyslipidemia

Exclusion Criteria:

• Homozygous familial hypercholesterolemia

• Conditions which may cause secondary dyslipidemia

• Uncontrolled diabetes mellitus

• Abnormal pancreatic, liver, or renal function

• Abnormal serum creatine kinase (CK) above the pre-specified level

• Significant heart disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCBR Aalborg	Aalborg		Denmark
2	CCBR A/S	Ballerup		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, Med Dr., Kowa Research Europe

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00309751
• Other Study ID Numbers: NK-104-305
• First Posted: Apr 3, 2006
• Last Update Posted: Feb 23, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: Kowa; Type II Diabetes Mellitus; Combined Dyslipidemia; pitavastatin; NK-104; Atorvastatin
• Additional relevant MeSH terms: Diabetes Mellitus; Dyslipidemias; Diabetes Mellitus, Type 2; Atorvastatin; Pitavastatin

Study Results

Participant Flow

Arm/Group Title	Pitavastatin 4 mg QD	Atorvastatin 20 mg QD
Arm/Group Description	Pitavastatin 4 mg once daily	Atorvastatin 20 mg once daily
Period Title: Overall Study
STARTED	279	139
Safety Population	275	137
COMPLETED	248	124
NOT COMPLETED	31	15

Baseline Characteristics

Arm/Group Title	Pitavastatin 4 mg QD	Atorvastatin 20 mg QD	Total
Arm/Group Description	Pitavastatin 4 mg once daily	Atorvastatin 20 mg once daily	Total of all reporting groups
Overall Participants	275	137	412
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	191 69.5%	93 67.9%	284 68.9%
>=65 years	84 30.5%	44 32.1%	128 31.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (9.21)	59.8 (9.06)	59.4 (9.15)
Sex: Female, Male (Count of Participants)
Female	120 43.6%	59 43.1%	179 43.4%
Male	155 56.4%	78 56.9%	233 56.6%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
Description	Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin 4 mg QD	Atorvastatin 20 mg QD
Arm/Group Description	Pitavastatin 4 mg once daily	Atorvastatin 20 mg once daily
Measure Participants	274	136
Mean (Standard Deviation) [percent change]	-40.78 (19.599)	-43.25 (16.378)

2. Secondary Outcome

Title	Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target
Description	Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin 4 mg QD	Atorvastatin 20 mg QD
Arm/Group Description	Pitavastatin 4 mg once daily	Atorvastatin 20 mg once daily
Measure Participants	274	136
Number [Participants]	212 77.1%	111 81%

Adverse Events

Arm/Group Title	Pitavastatin 4 mg QD		Atorvastatin 20 mg QD
Arm/Group Description	Pitavastatin 4 mg once daily		Atorvastatin 20 mg once daily
All Cause Mortality
	Pitavastatin 4 mg QD		Atorvastatin 20 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pitavastatin 4 mg QD		Atorvastatin 20 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/ (NaN)		4/ (NaN)
Cardiac disorders
Myocardial infarction	1/275 (0.4%)		0/137 (0%)
Tachycardia paroxysmal	1/275 (0.4%)		0/137 (0%)
General disorders
Non-cardiac chest pain	0/275 (0%)		1/137 (0.7%)
Infections and infestations
Gastroenteritis	1/275 (0.4%)		0/137 (0%)
Injury, poisoning and procedural complications
Alcohol poisoning	0/275 (0%)		1/137 (0.7%)
Humerus fracture	0/275 (0%)		1/137 (0.7%)
Investigations
Blood creatinine increased	1/275 (0.4%)		0/137 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder	0/275 (0%)		1/137 (0.7%)
Other (Not Including Serious) Adverse Events
	Pitavastatin 4 mg QD		Atorvastatin 20 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/ (NaN)		22/ (NaN)
Gastrointestinal disorders
Diarrhea	6/275 (2.2%)		9/137 (6.6%)
Infections and infestations
Nasopharyngitis	12/275 (4.4%)		9/137 (6.6%)
Musculoskeletal and connective tissue disorders
Myalgia	11/275 (4%)		0/137 (0%)
Vascular disorders
Hypertension	0/275 (0%)		4/137 (2.9%)

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.