In total, 421 individuals were randomised and analysed, having received evolocumab (280 participants) or placebo (141 participants) (mean age 62 years 44% women 77% white). Exploratory analyses included percentage changes in fasting and post mixed-meal tolerance test (MMTT) lipoproteins and lipids, glucose metabolism variables and inflammatory biomarkers. Additional endpoints included LDL-C <1.81 mmol/l, LDL-C reduction ≥50% and other lipids. Co-primary endpoints were mean percentage change in LDL-C from baseline to week 12 and to the mean of weeks 10 and 12. Treatment assignment was blinded to the sponsor study team, investigators, site staff and patients throughout the study. Allocation was concealed using the centralised randomisation process. Randomisation was performed centrally via an interactive web-based or voice recognition system.

Participants were randomised 2:1 to evolocumab 420 mg s.c.

Lipid eligibility criteria varied by history of clinical cardiovascular disease.

The study aimed to examine the efficacy of 12 weeks of monthly evolocumab or placebo in lowering LDL-cholesterol (LDL-C) in individuals with type 2 diabetes and hypercholesterolaemia or mixed dyslipidaemia and on a maximum-tolerated statin of at least moderate intensity.įor this randomised, placebo-controlled outpatient study, eligible individuals were ≥18 years old with type 2 diabetes, HbA1c <10% (86 mmol/mol), had been on stable pharmacological therapy for diabetes for ≥6 months and were taking a maximum-tolerated statin dose of at least moderate intensity.

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