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)

• Status: Completed
• Trial end date: 2017-05-15
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Ezetimibe; Fenofibrate; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypoglycemic Agents; Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion criteria:

• 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.

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.

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