ODYSSEY DM‐Dyslipidemia

Trial name or title	ODYSSEY DM‐Dyslipidemia
Methods	Open‐label parallel randomised controlled trials
Participants	Inclusion criteria Patients with type 2 diabetes and mixed dyslipidaemia whose non‐high‐density lipoprotein cholesterol (non‐HDL‐C) is not adequately controlled with a stable, maximum dose/regimen of statin that is tolerated by the patient 18 years of age or older Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least 1 additional cardiovascular risk factor Non‐HDL‐C ≥ 100 mg/dL Triglycerides ≥ 150 mg/dL and < 500 mg/dL Stable antihyperglycaemic agents for ≥ 3 months No change in weight ≥ 5 kg within the prior 3 months On stable dose of medications that are known to influence weight and/or lipids within the previous 3 months Exclusion criteria Use of any lipid‐modifying therapies other than statins within the previous 4 weeks (e.g. ezetimibe, fenofibrate, nicotinic acid, omega‐3 fatty acids) or use of over‐the‐counter products/nutraceuticals known to impact lipids (e.g. red yeast rice) within previous 4 weeks Currently drinking more than 2 standard alcoholic drinks per day Body mass index (BMI) > 45 kg/m² or currently enrolled in a weight loss programme and still in active phase of weight loss Glycosylated haemoglobin (HbA1c) ≥ 9% The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Interventions	Experimental: Alirocumab will be injected subcutaneously every 2 weeks starting with dose 1, with potential blinded uptitration to dose 2 at week 12. Background therapy such as antihyperglycaemic agents and statins will be administered as applicable or as per Investigator's judgement. Placebo injection for training purposes will be administered to participants Interventions: drug: ALIROCUMAB SAR236553 (REGN727) Drug: placebo Drug: statins Active comparator: Usual care will be administered orally on the basis of selection of the investigator before randomisation and includes initiation of ezetimibe, fenofibrate, nicotinic acid or omega‐3 fatty acids. Alternatively, if randomised to the usual care arm, the investigator may select no additional lipid‐lowering agents. Background therapy such as antihyperglycaemic agents and statins will be administered as applicable or as per Investigator's judgement. Placebo injection for training purposes will be administered to participantsI Interventions: drug: placebo Drug: statins Drug: ezetimibe Drug: fenofibrate Drug: nicotinic acid Drug: omega‐3 fatty acids
Outcomes	Percent change in non‐HDL‐C in the intent‐to‐treat (ITT) population
Starting date	December 2015
Contact information
Notes	Sanofi