Type II Diabetes Mellitus and Combined Dyslipidemia MedDRA version: 7.1 Level: LLT Classification code 10058110
Conditions
Sponsors
Kowa Research Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females (age 18-75 years); 2. Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy); 3. Glycosylated hemoglobin A1c (HbA1c) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Homozygous familial hypercholesterolemia (heterozygous component of familial hypercholesterolemia is acceptable for inclusion); 2. Any conditions which may cause secondary dyslipidemia. 3. Uncontrolled diabetes mellitus as defined by glycosylated hemoglobin A1c (HbA1c) >7.5%. 4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. 5. Any history of pancreatic injury or pancreatitis, or impaired pancreatic function/injury as indicated by abnormal lipase or amylase; 6. Liver injury as indicated by serum transaminase levels (ALAT/serum glutamic pyruvic transaminase [SGPT], ASAT/serum glutamic oxaloacetic transaminase [SGOT]) >1.5 x upper limit of the reference range [ULRR] over the lead in period). 7. Impaired renal function as indicated by serum creatinine levels >1.5 x ULRR at Visit 1 (Week –8/-6). 8. Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator; 9. Serum CK > 5 x ULRR without a clinical explanation. However, if at Visit 1 (Week-8/-6) serum CK is > 5 x ULRR with a clinical explanation (such as extreme exertion or intramuscular injections, etc), one re-test will be allowed. 10. Uncontrolled hypothyroidism defined as TSH > ULRR. 11. Any severe acute illness or severe trauma in the last 3 months prior to Visit 1 (Week –8/-6); 12. Major surgery, during the 3 months prior to Visit 1 (Week –8/-6); 13. Significant CVD prior to randomization, such as myocardial infarction, coronary or peripheral artery angioplasty, bypass graft surgery or severe or unstable angina pectoris within the last 3 months; 14. Evidence of symptomatic heart failure (New York Heart Association [NYHA] class III or IV), gross cardiac enlargement (cardiothoracic ratio >0.5); significant heart block or cardiac arrhythmia. 15. In patients where the left ventricular ejection fraction (LVEF) is known this should be 10 years. Patients with prior history of basal cell carcinoma or squamous cell carcinoma of the skin remain eligible if they have been cancer free for >5 the past years; 22. Within the last 2 years, a history of drug abuse or continuous consumption of more than
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of pitavastatin 4 mg once daily (QD) versus (vs.) atorvastatin 20 mg QD with respect to the reduction of LDL-C, when administered for 12 weeks using an up titration regimen.;Secondary Objective: To compare the efficacy of pitavastatin 4 mg QD vs. atorvastatin 20 mg QD with respect to changes from baseline in other lipid and lipoprotein fractions (TC, HDL C, TC:HDL-C ratio, non-HDL:HDL-C ratio, TG, Apo B and apolipoprotein A1 [Apo-A1], Apo-B:Apo-A1 ratio, high sensitivity C-reactive protein [hs-CRP], adiponectin, small dense-LDL, remnant-like particle-cholesterol [RLP-C], oxidized LDL, and LDL-C target attainment [European Atherosclerosis Society {EAS} and National Cholesterol Education Program {NCEP}]); To assess the safety and tolerability of pitavastatin 4 mg QD when administered for 12 weeks using an up-titration regimen. ;Primary end point(s): To demonstrate the non-inferiority of pitavastatin 4 mg once daily (QD) versus (vs.) atorvastatin 20 mg QD. | — |
Countries
Denmark, Germany, United Kingdom
Outcome results
None listed