NCT02642159

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)

A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients With Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk With Non-HDL-C Not Adequately Controlled With Maximally Tolerated Statin Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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. For the purpose of scientific communication, a first-step analysis (both efficacy and safety) was performed at the Week 24 cut-off date. A second-step analysis was performed once all participants had completed the study to include a final update of the safety analysis.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Alirocumab	Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
DRUG	Statins	Statins at stable dose without other LMT as clinically indicated.
DRUG	Ezetimibe	Pharmaceutical form: tablet Route of administration: oral
DRUG	Fenofibrate	Pharmaceutical form: tablet Route of administration: oral
DRUG	Nicotinic acid	Pharmaceutical form: tablet Route of administration: oral
DRUG	Omega-3 fatty acids	Pharmaceutical form: tablet Route of administration: oral
DRUG	Antihyperglycemic Drug	Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.

Timeline

• Start date: 2016-03-15
• Primary completion: 2017-03-22
• Completion: 2017-05-15
• First posted: 2015-12-30
• Last updated: 2018-05-01
• Results posted: 2018-05-01

Locations

119 sites across 15 countries: United States, Australia, Brazil, Finland, Germany, Israel, Italy, Kuwait, Lebanon, Norway, Sweden, Switzerland, Turkey (Türkiye), United Arab Emirates, United Kingdom