Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolaemia

In brief

Primary Objectives: * To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. * To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin. Secondary Objective: To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol \[non-HDL-C\], apolipoprotein B \[Apo B\], total cholesterol \[TC\], lipoprotein a \[Lp(a)\], high density lipoprotein cholesterol \[HDL-C\], triglyceride \[TG\] levels, triglyceride rich lipoproteins \[TGRL\], apolipoprotein A-1 \[Apo A-1\], apolipoprotein C-III \[Apo C-III\], and LDL particle number and size).

Key facts

Study ID

NCT02585778

Run by

Sanofi

People needed

517

Starts

2015-10-23

Expected to finish

2017-04-03

Last updated by the study team

2018-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants diagnosed with Type 1 or Type 2 diabetes at least one year prior to the screening visit (Week -3).
• Signed written informed consent
• Participants with type 1 or type 2 diabetes treated with insulin whose LDL-C levels were not adequately controlled with maximally tolerated lipid-modifying therapy
• LDL-C of 70 mg/dL or greater
• 18 years of age or more
• Glycosylated hemoglobin (HbA1c) less than 10%
• History of cardiovascular disease (including coronary heart disease [CHD] and/or CHD risk equivalents) and/or at least one additional cardiovascular risk factor

You may not qualify if…

• Not on a stable dose of statin or other lipid modifying therapy for at least 4 weeks prior to screening or from screening to randomization, unless statin intolerant
• Triglycerides >400 mg/dL
• Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m² according to the Modification of Diet in Renal Disease (MDRD) equation
• Currently received or planned to receive renal replacement therapy (for example, hemodialysis)
• Change in weight of more than 5 kilograms within the prior 2 months
• Not on a stable dose/regimen of insulin or other antidiabetic drugs for the past 3 months or planned to intensify insulin regimen during the study
• Not treated with insulin for at least 6 months
• Planned to start new lipid modifying therapy or change dose of current lipid modifying therapy during the study
• Body mass index (BMI) >45 kg/m² or planned to undergo bariatric surgery, weight loss program, or initiate weight loss drugs during the study
• History of recent decompensation of diabetes within the prior 2 months (for example, diabetic ketoacidosis)
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840002 — Fresno, California, United States
• Investigational Site Number 840029 — Oakland, California, United States
• Investigational Site Number 840027 — Loveland, Colorado, United States
• Investigational Site Number 840026 — Atlantis, Florida, United States
• Investigational Site Number 840006 — Bradenton, Florida, United States
• Investigational Site Number 840023 — Jacksonville, Florida, United States
• Investigational Site Number 840028 — Palm Harbor, Florida, United States
• Investigational Site Number 840022 — Ponte Vedra Beach, Florida, United States
• Investigational Site Number 840021 — Roswell, Georgia, United States
• Investigational Site Number 840007 — Springfield, Illinois, United States
• Investigational Site Number 840011 — Indianapolis, Indiana, United States
• Investigational Site Number 840015 — Valparaiso, Indiana, United States
• Investigational Site Number 840010 — Des Moines, Iowa, United States
• Investigational Site Number 840005 — Louisville, Kentucky, United States
• Investigational Site Number 840018 — Auburn, Maine, United States
• Investigational Site Number 840013 — Hyattsville, Maryland, United States
• Investigational Site Number 840016 — Rockville, Maryland, United States
• Investigational Site Number 840004 — Minneapolis, Minnesota, United States
• Investigational Site Number 840012 — Jamaica, New York, United States
• Investigational Site Number 840014 — Maumee, Ohio, United States
• Investigational Site Number 840009 — Greer, South Carolina, United States
• Investigational Site Number 840024 — Chattanooga, Tennessee, United States
• Investigational Site Number 840001 — Austin, Texas, United States
• Investigational Site Number 840003 — Dallas, Texas, United States
• Investigational Site Number 840020 — Encino, California, United States

Full record on ClinicalTrials.gov

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