Dyslipidemia, Type II Diabetes Mellitus
Conditions
Keywords
Pitavastatin, Type II Diabetes Mellitus, Combined Dyslipidemia
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.
Interventions
DRUGPitavastatin
Pitavastatin 4 mg QD
DRUGAtorvastatin
Atorvastatin 40 mg
Sponsors
Kowa Research Europe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Type II diabetes mellitus * Combined dyslipidemia * Completed NK-104-305 (NCT00309751)
Exclusion criteria
* Withdrawal from NK-104-305 (NCT00309751)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in LDL-C | Basseline to 44 weeks | Percent change from baseline in LDL-C at 44 weeks |
Countries
Denmark, Germany, India, Netherlands, Poland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin 4 mg Pitavastatin 4 mg once daily | 143 |
| Atorvastatin 40 mg Atorvastatin 40 mg once daily | 71 |
| Total | 214 |
Baseline characteristics
| Characteristic | Pitavastatin 4 mg | Atorvastatin 40 mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 25 Participants | 73 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants | 46 Participants | 141 Participants |
| Age Continuous | 59.3 years STANDARD_DEVIATION 9.83 | 60.0 years STANDARD_DEVIATION 9.21 | 59.5 years STANDARD_DEVIATION 9.61 |
| Sex: Female, Male Female | 68 Participants | 30 Participants | 98 Participants |
| Sex: Female, Male Male | 75 Participants | 41 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 143 | 15 / 71 |
| serious Total, serious adverse events | 8 / 143 | 5 / 71 |
Outcome results
Primary
NCEP LDL-C Target Attainment
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Pitavastatin 4 mg | NCEP LDL-C Target Attainment | 110 Participants |
| Atorvastatin 40 mg | NCEP LDL-C Target Attainment | 55 Participants |
Secondary
Percent Change From Baseline in LDL-C
Percent change from baseline in LDL-C at 44 weeks
Time frame: Basseline to 44 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 4 mg | Percent Change From Baseline in LDL-C | -40.98 percent change | Standard Deviation 19.053 |
| Atorvastatin 40 mg | Percent Change From Baseline in LDL-C | -41.43 percent change | Standard Deviation 21.159 |