Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults with Hypercholesterolemia/Mixed DyslipidemiaBANTING
Study Details
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.
Protocol Summary
Mean percent change from baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Timeframe: Weeks 10 and 12
Percent change from baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Timeframe: Week 12
Change from baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Timeframe: For the mean of weeks 10 and 12 and for week 12
Percent change from baseline in Non-High Density Lipoprotein-Cholesterol (HDL-C)
Timeframe: For the mean of weeks 10 and 12 and for week 12
Percent change from baseline in Apolipoprotein B (ApoB)
Timeframe: For the mean of weeks 10 and 12 and for week 12
Percent change from baseline in Total Cholesterol (TC)
Timeframe: For the mean of weeks 10 and 12 and for week 12
Achievement of target Low Density Lipoprotein-Cholesterol <70 mg/dL (1.8 mmol/L)
Timeframe: For the mean of weeks 10 and 12 and for week 12
Low Density Lipoprotein-Cholesterol response (50% reduction of LDL-C from baseline)
Timeframe: For the mean of weeks 10 and 12 and for week 12
Percent change from baseline in Lipoprotein (a) {Lp(a)}
Timeframe: For the mean of weeks 10 and 12 and for week 12
Percent change from baseline in triglycerides
Timeframe: For the mean of weeks 10 and 12 and for week 12:
Percent change from baseline in High Density Lipoprotein-Cholesterol (HDL-C)
Timeframe: For the mean of weeks 10 and 12 and for week 12
Percent change from baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Timeframe: For the mean of weeks 10 and 12 and for week 12