Evidence map›Paper›PMID 28905478›Full record

Trial reportDiabetes, obesity & metabolism2017

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.

Lawrence A Leiter, Bertrand Cariou, Dirk Müller-Wieland, Helen M Colhoun, Stefano Del Prato, Francisco J Tinahones, Kausik K Ray, Maja Bujas-Bobanovic, Catherine Domenger, Jonas Mandel and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & 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 61 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 11 pooled it
18.6field-weighted citation impact, top 1% 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

61 citing papers in PubMed, 11 syntheses or guidelines pooled it, 138 citations in OpenAlex.

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  7. Biotechnology Approaches for the Treatment of Dyslipidemia.Cardiovascular drugs and therapy · 2021
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  8. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2020 · on this map
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1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 7 countries.

Lawrence A LeiterLi Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-1040-6229
Bertrand CariouDepartment of Endocrinology, l'institut du thorax, CHU Nantes, INSERM, CNRS, UNIV Nantes, Nantes, France.
Dirk Müller-WielandDepartment of Internal Medicine I, University Hospital RWTH Aachen, Aachen, Germany.
Helen M ColhounUniversity of Edinburgh, Edinburgh, UK.
Stefano Del PratoDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.ORCID 0000-0002-5388-0270
Francisco J TinahonesHospital Virgen de la Victoria, CIBERobn, Málaga University, Málaga, Spain.
Kausik K RayDepartment of Primary Care and Public Health, School of Public Health, Imperial College London, London, UK.
Maja Bujas-BobanovicSanofi, Paris, France.
Catherine DomengerSanofi, Gentilly, France.
Jonas MandelSanofi, Chilly-Mazarin, France.
Rita SamuelRegeneron Pharmaceuticals, Inc., Tarrytown, New York.
Robert R HenryUniversity of California San Diego School of Medicine, and Center for Metabolic Research, Veterans Affairs, San Diego Healthcare System, San Diego, California.ORCID 0000-0002-4821-0117
Sanofi (France) · FRCentre National de la Recherche Scientifique · FRHospital Clínico Universitario Virgen de la Victoria · ESPublic Health England · GBRegeneron (United States) · USRWTH Aachen University · DESt. Michael's Hospital · CAUniversity of California San Diego · USUniversity of Edinburgh · GBUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate the efficacy and safety of alirocumab in participants with type 2 (T2D) or type 1 diabetes (T1D) treated with insulin who have elevated LDL cholesterol levels despite maximally tolerated statin therapy.

methodsParticipants at high cardiovascular risk with T2D (n = 441) or T1D (n = 76) and LDL cholesterol levels ≥1.8 mmol/L (≥70 mg/dL) were randomized 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks, for 24 weeks' double-blind treatment. Alirocumab-treated participants received 75 mg every 2 weeks, with blinded dose increase to 150 mg every 2 weeks at week 12 if week 8 LDL cholesterol levels were ≥1.8 mmol/L. Primary endpoints were percentage change in calculated LDL cholesterol from baseline to week 24, and safety assessments.

resultsAlirocumab reduced LDL cholesterol from baseline to week 24 by a mean ± standard error of 49.0% ± 2.7% and 47.8% ± 6.5% vs placebo (both P < .0001) in participants with T2D and T1D, respectively. Significant reductions were observed in non-HDL cholesterol (P < .0001), apolipoprotein B (P < .0001) and lipoprotein (a) (P ≤ .0039). At week 24, 76.4% and 70.2% of the alirocumab group achieved LDL cholesterol <1.8 mmol/L in the T2D and T1D populations (P < .0001), respectively. Glycated haemoglobin and fasting plasma glucose levels remained stable for the study duration. Treatment-emergent adverse events were observed in 64.5% of alirocumab- vs 64.1% of placebo-treated individuals (overall population).

conclusionsAlirocumab produced significant LDL cholesterol reductions in participants with insulin-treated diabetes regardless of diabetes type, and was generally well tolerated. Concomitant administration of alirocumab and insulin did not raise any safety concerns (NCT02585778).

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCardiovascular DiseasesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic AngiopathiesDiabetic CardiomyopathiesDouble-Blind MethodDrug Administration ScheduleDrug ResistanceFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsalirocumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsHydroxymethylglutaryl-CoA Reductase InhibitorsHypoglycemic AgentsInsulincardiovascular diseaseclinical triallipid-lowering therapytype 1 diabetestype 2 diabetes

Identifiers

PMID28905478
PMCPMC5698740
OpenAlexW2756174617

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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.