Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients with Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

Phase 1

• Conditions: Dyslipidemia; MedDRA version: 20.0Level: PTClassification code 10058108Term: DyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-001934-19-DE
• Lead Sponsor: Sanofi-Aventis Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-27
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

-Patients with type 2 diabetes and mixed dyslipidemia whose non-high-density lipoprotein cholesterol (non-HDL-C) is not adequately controlled with a stable, maximum dose/regimen of statin that is tolerated by the patient.
-18 years of age or more.
-Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least one additional cardiovascular risk factor.
-Non-HDL-C of 100 mg/dL or greater.
-Triglycerides greater than or equal to 150 mg/dL and less than 500 mg/dL.
-Stable anti-hyperglycemic agents for at least 3 months.
-No change in weight of more than 5 kg within the prior 3 months.
-On stable dose of medications that are known to influence weight and/or lipids within the last 3 months.

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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

-Use of any lipid modifying therapies other than statins within the last 4 weeks (eg, ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the last 4 weeks.
-Currently drinking more than 2 standard alcoholic drinks per day.
-Body Mass Index (BMI) >45 kg/m² or currently enrolled in a weight loss program and still in active phase of weight loss.
-Glycosylated hemoglobin (HbA1c) 9% or greater.

Study & Design

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