Müller-Wieland, DirkLeiter, Lawrence ACariou, BertrandLetierce, AlexiaColhoun, Helen MDel Prato, StefanoHenry, Robert RTinahones, Francisco JAurand, LisaMaroni, JamanRay, Kausik KBujas-Bobanovic, Maja2023-01-252023-01-252017-05-25http://hdl.handle.net/10668/11240Type 2 diabetes mellitus (T2DM) is often associated with mixed dyslipidaemia, where non-high-density lipoprotein cholesterol (non-HDL-C) levels may more closely align with cardiovascular risk than low-density lipoprotein cholesterol (LDL-C). We describe the design and rationale of the ODYSSEY DM-DYSLIPIDEMIA study that assesses the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk with non-HDL-C inadequately controlled despite maximally tolerated statin therapy. For the first time, atherogenic cholesterol-lowering with a PCSK9 inhibitor will be assessed with non-HDL-C as the primary endpoint with usual care as the comparator. DM-DYSLIPIDEMIA is a Phase 3b/4, randomised, open-label, parallel group, multinational study that planned to enrol 420 individuals. Main inclusion criteria were T2DM and mixed dyslipidaemia (non-HDL-C ≥100 mg/dl [≥2.59 mmol/l], and triglycerides ≥150 and  Recruitment completed with 413 individuals randomised in 14 countries worldwide. Results of this trial are expected in the second quarter of 2017. ODYSSEY DM-DYSLIPIDEMIA will provide information on the efficacy and safety of alirocumab versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk using non-HDL-C as the primary efficacy endpoint. Trial registration NCT02642159 (registered December 24, 2015).enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/AlirocumabDiabetesMixed dyslipidaemiaNon-HDL-CODYSSEYPCSK9Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsBiomarkersCholesterolClinical ProtocolsDiabetes Mellitus, Type 2HumansHyperlipoproteinemia Type VPCSK9 InhibitorsProprotein Convertase 9Research DesignTime FactorsTreatment Outcomeresearch article28545518open access10.1186/s12933-017-0552-41475-2840PMC5445362https://doi.org/10.1186/s12933-017-0552-4https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5445362/pdf