Trial Outcomes & Findings for Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia (NCT NCT00309751)

NCT ID: NCT00309751

Last Updated: 2010-02-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 418 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2010-02-23

Participant Flow

Participant milestones

Measure	Pitavastatin 4 mg QD Pitavastatin 4 mg once daily	Atorvastatin 20 mg QD Atorvastatin 20 mg once daily
Overall Study STARTED	279	139
Overall Study Safety Population	275	137
Overall Study COMPLETED	248	124
Overall Study NOT COMPLETED	31	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pitavastatin 4 mg QD n=275 Participants Pitavastatin 4 mg once daily	Atorvastatin 20 mg QD n=137 Participants Atorvastatin 20 mg once daily	Total n=412 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	191 Participants n=5 Participants	93 Participants n=7 Participants	284 Participants n=5 Participants
Age, Categorical >=65 years	84 Participants n=5 Participants	44 Participants n=7 Participants	128 Participants n=5 Participants
Age Continuous	59.1 years STANDARD_DEVIATION 9.21 • n=5 Participants	59.8 years STANDARD_DEVIATION 9.06 • n=7 Participants	59.4 years STANDARD_DEVIATION 9.15 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	59 Participants n=7 Participants	179 Participants n=5 Participants
Sex: Female, Male Male	155 Participants n=5 Participants	78 Participants n=7 Participants	233 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Pitavastatin 4 mg QD n=274 Participants Pitavastatin 4 mg once daily	Atorvastatin 20 mg QD n=136 Participants Atorvastatin 20 mg once daily
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)	-40.78 percent change Standard Deviation 19.599	-43.25 percent change Standard Deviation 16.378

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Pitavastatin 4 mg QD n=274 Participants Pitavastatin 4 mg once daily	Atorvastatin 20 mg QD n=136 Participants Atorvastatin 20 mg once daily
Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target	212 Participants	111 Participants

Adverse Events

Pitavastatin 4 mg QD

Serious events: 4 serious events

Other events: 29 other events

Deaths: 0 deaths

Atorvastatin 20 mg QD

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pitavastatin 4 mg QD Pitavastatin 4 mg once daily	Atorvastatin 20 mg QD Atorvastatin 20 mg once daily
Cardiac disorders Myocardial infarction	0.36% 1/275	0.00% 0/137
Cardiac disorders Tachycardia paroxysmal	0.36% 1/275	0.00% 0/137
General disorders Non-cardiac chest pain	0.00% 0/275	0.73% 1/137
Infections and infestations Gastroenteritis	0.36% 1/275	0.00% 0/137
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/275	0.73% 1/137
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/275	0.73% 1/137
Investigations Blood creatinine increased	0.36% 1/275	0.00% 0/137
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/275	0.73% 1/137

Other adverse events

Measure	Pitavastatin 4 mg QD Pitavastatin 4 mg once daily	Atorvastatin 20 mg QD Atorvastatin 20 mg once daily
Gastrointestinal disorders Diarrhea	2.2% 6/275	6.6% 9/137
Infections and infestations Nasopharyngitis	4.4% 12/275	6.6% 9/137
Musculoskeletal and connective tissue disorders Myalgia	4.0% 11/275	0.00% 0/137
Vascular disorders Hypertension	0.00% 0/275	2.9% 4/137

Additional Information

Bill Arana

Kowa Research Institute Inc

Phone: 919 433 1600

Email: barana@kowaus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60