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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)
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)

NCT02585778

CompletedPhase 3

Sponsor: Sanofi

Conditions: Hypercholesterolaemia

Interventions: Alirocumab, Placebo, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug

Countries: United States, Austria, Belgium, France, Germany, Italy, Netherlands, Spain

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

* 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

Exclusion criteria:

* 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.
Locations (110)
  • Encino, California, United States
  • Fresno, California, United States
  • Oakland, California, United States
  • Loveland, Colorado, United States
  • Atlantis, Florida, United States
  • Bradenton, Florida, United States
  • Jacksonville, Florida, United States
  • Palm Harbor, Florida, United States
  • Ponte Vedra Beach, Florida, United States
  • Roswell, Georgia, United States
  • Springfield, Illinois, United States
  • Indianapolis, Indiana, United States
  • Valparaiso, Indiana, United States
  • Des Moines, Iowa, United States
  • Louisville, Kentucky, United States
  • Auburn, Maine, United States
  • Hyattsville, Maryland, United States
  • Rockville, Maryland, United States
  • Minneapolis, Minnesota, United States
  • Jamaica, New York, United States
  • Maumee, Ohio, United States
  • Greer, South Carolina, United States
  • Chattanooga, Tennessee, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Ogden, Utah, United States
  • Salt Lake City, Utah, United States
  • Innsbruck, Austria
  • + 80 more on CT.gov