Elsevier

Diabetes & Metabolism

Volume 43, Issue 5, October 2017, Pages 453-459
Diabetes & Metabolism

Original article
Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY DM–INSULIN trial

https://doi.org/10.1016/j.diabet.2017.01.004Get rights and content
Under a Creative Commons license
open access

Abstract

Aims

The coadministration of alirocumab, a PCSK9 inhibitor for treatment of hypercholesterolaemia, and insulin in diabetes mellitus (DM) requires further study. Described here is the rationale behind a phase-IIIb study designed to characterize the efficacy and safety of alirocumab in insulin-treated patients with type 1 (T1) or type 2 (T2) DM with hypercholesterolaemia and high cardiovascular (CV) risk.

Methods

ODYSSEY DM–INSULIN (NCT02585778) is a randomized, double-blind, placebo-controlled, multicentre study that planned to enrol around 400 T2 and up to 100 T1 insulin-treated DM patients. Participants had low-density lipoprotein cholesterol (LDL-C) levels at screening  70 mg/dL (1.81 mmol/L) with stable maximum tolerated statin therapy or were statin-intolerant, and taking (or not) other lipid-lowering therapy; they also had established CV disease or at least one additional CV risk factor. Eligible patients were randomized 2:1 to 24 weeks of alirocumab 75 mg every 2 weeks (Q2W) or a placebo. Alirocumab-treated patients with LDL-C  70 mg/dL at week 8 underwent a blinded dose increase to 150 mg Q2W at week 12. Primary endpoints were the difference between treatment arms in percentage change of calculated LDL-C from baseline to week 24, and alirocumab safety.

Results

This is an ongoing clinical trial, with 76 T1 and 441 T2 DM patients enrolled; results are expected in mid-2017.

Conclusion

The ODYSSEY DM–INSULIN study will provide information on the efficacy and safety of alirocumab in insulin-treated individuals with T1 or T2 DM who are at high CV risk and have hypercholesterolaemia not adequately controlled by the maximum tolerated statin therapy.

Keywords

Alirocumab
Diabetes
Insulin
LDL-C
ODYSSEY
PCSK9

Abbreviations

AE
adverse event
Apo
apolipoprotein
ASCVD
atherosclerotic cardiovascular disease
CHD
coronary heart disease
CV
cardiovascular
CVD
cardiovascular disease
DM
diabetes mellitus
HDL-C
high-density lipoprotein cholesterol
I-TAQ
Injection-Treatment Acceptance Questionnaire
ITT
intention-to-treat
LDL-C
low-density lipoprotein cholesterol
LDL-P
LDL particle
LLT
lipid-lowering therapy
Lp(a)
lipoprotein(a)
MI
myocardial infarction
mITT
modified intention-to-treat
MMRM
mixed-effects model with repeated measures
PAD
peripheral arterial disease
PCSK9
proprotein convertase subtilisin/kexin type 9
Q2W
every 2 weeks
TG
triglyceride
T1
type 1
T2
type 2
UA
unstable angina

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