Evidence map›Paper›PMID 28386990›Full record

Trial reportDiabetes, obesity & metabolism2017

Consistent findings in glycaemic control, body weight and hypoglycaemia with iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) vs insulin glargine across baseline HbA1c, BMI and diabetes duration categories in the LixiLan-L trial.

Carol Wysham, Riccardo C Bonadonna, Vanita R Aroda, Manuel Puig Domingo, Christoph Kapitza, William Stager, Christine Yu, Elisabeth Niemoeller, Elisabeth Souhami, Richard M Bergenstal and 1 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
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 reports registered trial NCT02058160. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
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.

NCT02058160 phase3completed

A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

Ran2014Enrolled736Registered outcomes15Posted comparisons8ConditionsType 2 DiabetesArmsInsulin glargine (HOE901), Insulin glargine/lixisenatide (HOE901/AVE0010), Metformin (Background drug)
PMID 27650977other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Trial
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  11. Role of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists in Hypoglycemia.Clinical medicine insights. Endocrinology and diabetes · 2021
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Carol WyshamRockwood Clinic, Spokane, Washington.ORCID 0000-0002-3056-0047
Riccardo C BonadonnaDivision of Endocrinology and Metabolic Diseases, Department of Clinical and Experimental Medicine, University of Parma and AOU of Parma, Parma, Italy.
Vanita R ArodaMedstar Health Research Institute, Hyattsville, Maryland.
Manuel Puig DomingoGermans Trias i Pujol Research Institute and Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.
Christoph KapitzaProfil Institute, Neuss, Germany.
William StagerSanofi, Bridgewater, New Jersey.
Christine YuSanofi, Bridgewater, New Jersey.
Elisabeth NiemoellerSanofi, Frankfurt, Germany.
Elisabeth SouhamiSanofi, Paris, France.
Richard M BergenstalInternational Diabetes Center, Park Nicollet Health Services, Minneapolis, Minnesota.
LixiLan-L trial investigators

Funding

Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
NCATS NIH HHS UL1 TR001409
6 · The paper itself

Abstract

aimsTo assess the impact of baseline characteristics on clinical outcomes in the LixiLan-L trial, a randomized open-label trial designed to evaluate the efficacy and safety of iGlarLixi, a novel fixed-ratio combination of insulin glargine 100 U (iGlar) plus lixisenatide, in comparison with iGlar over 30 weeks in a population of patients with type 2 diabetes mellitus (T2DM) inadequately controlled on a previous regimen of basal insulin alone or in combination with 1 or 2 oral glucose-lowering drugs. MATERIALS AND

methodsIn this exploratory analysis of LixiLan-L (N = 736), efficacy outcomes were assessed within population subgroups derived from the following baseline characteristics: glycated haemoglobin [HbA1c; <8%, ≥8% (<64, ≥64 mmol/mol)]; duration of T2DM (<10, ≥10 years); body mass index (<30, ≥30 kg/m

resultsCompared with the iGlar treatment group, patients treated with iGlarLixi showed consistently greater reductions in HbA1c during the treatment period, with higher percentages of patients achieving the HbA1c target level of <7% (<53 mmol/mol) in all of the subpopulations tested (P < .0001 for all), having consistent mitigation of body weight gain and with no major differences in the incidence of hypoglycaemia.

conclusionsiGlarLixi consistently improved glycaemic control compared with iGlar in all baseline characteristic subgroups of patients with T2DM inadequately controlled with insulin, including difficult-to-treat subgroups of patients with long duration of diabetes, obesity and high HbA1c. Clinical trial number: NCT02058160 (clinicaltrials.gov).

Indexed as

AdultAgedBlood GlucoseBody Mass IndexBody WeightDiabetes Mellitus, Type 2Drug CombinationsFemaleGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemiaInsulin GlargineMaleMiddle AgedPeptidesBlood GlucoseDrug CombinationsGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinInsulin GlarginelixisenatidePeptidesGLP-1glycaemic controlinsulin therapytype 2 diabetes

Identifiers

PMID28386990
PMCPMC5638095

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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 OpenQuestion graph.