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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
With
Regeneron Pharmaceuticals
The maximum study duration was approximately 9 months per participant, including a 6 month treatment period, a screening period of up to 3 weeks, and an 8 week safety observation period.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
