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)
Summary
Primary Objectives: * To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. * To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin. Secondary Objective: To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol \[non-HDL-C\], apolipoprotein B \[Apo B\], total cholesterol \[TC\], lipoprotein a \[Lp(a)\], high density lipoprotein cholesterol \[HDL-C\], triglyceride \[TG\] levels, triglyceride rich lipoproteins \[TGRL\], apolipoprotein A-1 \[Apo A-1\], apolipoprotein C-III \[Apo C-III\], and LDL particle number and size).
Timeline
- Start
- 2015-10-23
- Primary completion
- 2017-04-03
- Completion
- 2017-04-03
Outcome
Met primary endpoint
registry analysis (superiority test); Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants vs Placebo Q2W: T1DM Participants; p <0.0001; NCT02585778 ↗
registry LS Mean Difference -47.8 (95% CI -60.7 to -35.0) NCT02585778 ↗
registry analysis (superiority test); Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants vs Placebo Q2W: T2DM Participants; p <0.0001; NCT02585778 ↗
registry LS Mean Difference -49.0 (95% CI -54.4 to -43.6) NCT02585778 ↗
Publications
- Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
- Ray KK, Del Prato S, Muller-Wieland D, Cariou B, Colhoun HM, Tinahones FJ, Domenger C, Letierce A, Mandel J, Samuel R, Bujas-Bobanovic M, Leiter LA. Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies. Cardiovasc Diabetol. 2019 Nov 9;18(1):149. doi: 10.1186/s12933-019-0951-9.
- Leiter LA, Cariou B, Muller-Wieland D, Colhoun HM, Del Prato S, Tinahones FJ, Ray KK, Bujas-Bobanovic M, Domenger C, Mandel J, Samuel R, Henry RR. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial. Diabetes Obes Metab. 2017 Dec;19(12):1781-1792. doi: 10.1111/dom.13114. Epub 2017 Oct 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alirocumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Alirocumab | Monoclonal antibody | 150 mg | Subcutaneous |