Evidence map›Paper›PMID 28347654›Full record

Trial reportDiabetes & metabolism2017

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.

B Cariou, L A Leiter, D Müller-Wieland, G Bigot, H M Colhoun, S Del Prato, R R Henry, F J Tinahones, A Letierce, L Aurand and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes & metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02585778 (A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients With Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.7field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02585778 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients With Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy

TypeinterventionalSponsorSanofiRan2015 to 2017Enrolled517ConditionsHypercholesterolaemiaArmsAlirocumab, Placebo, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 7 countries.

B CariouInstitut du thorax, CHU Nantes, INSERM, CNRS, UNIV Nantes, 44093 Nantes cedex 1, France. Electronic address: bertrand.cariou@univ.nantes.fr.
L A LeiterLi KaShing Knowledge Institute and Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.
D Müller-WielandDepartment of Internal Medicine I, University Hospital Aachen, Aachen, Germany.
G BigotIVIDATA, 92300 Levallois-Perret, France.
H M ColhounUniversity of Edinburgh, Edinburgh, Scotland, UK.
S Del PratoDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
R R HenryUniversity of California San Diego School of Medicine, Center for Metabolic Research, Veterans Affairs, San Diego Healthcare System, San Diego, CA, USA.
F J TinahonesCIBERobn, Hospital Virgen de la Victoria, Málaga University, Spain.
A LetierceSanofi, 91380 Chilly-Mazarin, France.
L AurandSanofi, Bridgewater, NJ, USA.
J MaroniRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
K K RayDepartment of Primary Care and Public Health, School of Public Health, Imperial College, London, UK.
M Bujas-BobanovicSanofi, 75008 Paris, France.
Sanofi (France) · FRCentre National de la Recherche Scientifique · FRCentro de Investigación Biomédica en Red · ESImperial College London · GBRegeneron (United States) · USSanofi (United States) · USSt. Michael's Hospital · CAUniversitätsklinikum Aachen · DEUniversity of Edinburgh · GBUniversity of Pisa · ITVA San Diego Healthcare System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe 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.

methodsODYSSEY 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≥70mg/dL (1.81mmol/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 24weeks of alirocumab 75mg every 2weeks (Q2W) or a placebo. Alirocumab-treated patients with LDL-C≥70mg/dL at week 8 underwent a blinded dose increase to 150mg 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.

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

conclusionThe 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.

Indexed as

Research DesignAdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCardiovascular DiseasesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Double-Blind MethodDrug InteractionsFemaleHumansHypercholesterolemiaInsulinMalealirocumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedInsulinAlirocumabDiabetesInsulinLDL-CODYSSEYPCSK9

Identifiers

PMID28347654
OpenAlexW2601739689

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.