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)

Status:	Completed
Conditions:	High Cholesterol
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	5/19/2018
Start Date:	October 23, 2015
End Date:	April 3, 2017

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients With Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy

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).

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.

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.

We found this trial at

sites

Clinical Trial Facility in Springfield Illinois

Springfield, Illinois 62704

460

from

Springfield, IL