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)

Phase 1

• Conditions: Hypercholesterolemia; MedDRA version: 20.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-000799-92-DE
• Lead Sponsor: sanofi-aventis Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-05
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Patients with type 1 or type 2 diabetes treated with insulin whose LDL-C levels are 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 CHD and/or CHD risk equivalents) and/or at least one additional cardiovascular risk factor.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Not on a stable dose of statin or other lipid modifying therapy for at least 4 weeks prior to screening.
Triglycerides >400 mg/dL.
Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m^2 according to modification in diet of renal disease (MDRD) equation.
Currently receiving or plans 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 plans to intensify insulin regimen during the study.
Not treated with insulin for at least 6 months.
Plans to start new lipid modifying therapy or change dose of current lipid modifying therapy during the study.
Body mass index (BMI) >45 kg/m^2 or plans 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified