The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
986
Administered by subcutaneous injection
Administered orally once a day
Placebo to evolocumab administered by subcutaneous injection
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
Time frame: Baseline and week 12
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100 at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Total Cholesterol at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
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Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12
Time frame: Baseline and week 12
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)
Time frame: Weeks 10 and 12
Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12
Time frame: Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12