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)

Completed · Phase 4

Conditions studied: Dyslipidemia

In brief

Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy. Secondary Objectives: * To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp\[a\]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein \[VLDL\], HDL, and intermediate-density lipoprotein \[IDL\] particle number). * To assess changes in glycemic parameters with alirocumab vs. usual care treatment. * To demonstrate the safety and tolerability of alirocumab. * To evaluate treatment acceptance of alirocumab. * To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development. * To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).

Key facts

Study ID: NCT02642159
Run by: Sanofi
People needed: 413
Starts: 2016-03-15
Expected to finish: 2017-05-15
Last updated by the study team: 2018-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants with type 2 diabetes and mixed dyslipidemia whose non-HDL-C was not adequately controlled with a stable, maximum dose/regimen of statin that was tolerated by the participant.
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 prior to the screening visit and between screening and randomization (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months, as judged by the Investigator).
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.

You may not qualify if…

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.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

Investigational Site Number 840-141 — Fresno, California, United States
Investigational Site Number 840-152 — Huntington Beach, California, United States
Investigational Site Number 840-115 — La Jolla, California, United States
Investigational Site Number 840-118 — Los Angeles, California, United States
Investigational Site Number 840-106 — Northridge, California, United States
Investigational Site Number 840-176 — Port Hueneme, California, United States
Investigational Site Number 840-122 — Tarzana, California, United States
Investigational Site Number 840-156 — Tustin, California, United States
Investigational Site Number 840-160 — Van Nuys, California, United States
Investigational Site Number 840-107 — Boca Raton, Florida, United States
Investigational Site Number 840-170 — Boynton Beach, Florida, United States
Investigational Site Number 840-114 — Bradenton, Florida, United States
Investigational Site Number 840-132 — Ocoee, Florida, United States
Investigational Site Number 840-179 — Oviedo, Florida, United States
Investigational Site Number 840-123 — Tampa, Florida, United States
Investigational Site Number 840-137 — Bainbridge, Georgia, United States
Investigational Site Number 840-128 — Columbus, Georgia, United States
Investigational Site Number 840-169 — Stockbridge, Georgia, United States
Investigational Site Number 840-167 — Idaho Falls, Idaho, United States
Investigational Site Number 840-161 — Chicago, Illinois, United States
Investigational Site Number 840-184 — Crystal Lake, Illinois, United States
Investigational Site Number 840-174 — Evanston, Illinois, United States
Investigational Site Number 840-138 — Springfield, Illinois, United States
Investigational Site Number 840-108 — Louisville, Kentucky, United States
Investigational Site Number 840-163 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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