Evidence map›Paper›PMID 27650977›Full record

Trial reportDiabetes care2016

Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial.

Vanita R Aroda, Julio Rosenstock, Carol Wysham, Jeffrey Unger, Diego Bellido, Guillermo González-Gálvez, Akane Takami, Hailing Guo, Elisabeth Niemoeller, Elisabeth Souhami and 2 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes care, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT02058160. Cited by 145 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
145citing papers in PubMed, 12 pooled it
24.8field-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.

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)
Open the trial in the graph
3 · Its place in the literature

Who cites it

145 citing papers in PubMed, 12 syntheses or guidelines pooled it, 246 citations in OpenAlex.

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85 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 11 institutions in 6 countries.

Vanita R ArodaMedstar Health Research Institute, Hyattsville, MD vanita.aroda@medstar.net.
Julio RosenstockDallas Diabetes Research Center at Medical City, Dallas, TX.
Carol WyshamRockwood Clinic, Spokane, WA.
Jeffrey UngerCatalina Research Institute, Chino, CA.
Diego BellidoComplejo Hospitalario Universitario de Ferrol, A Coruña University, A Coruña, Spain.
Guillermo González-GálvezInstituto Jalisciense de Investigación en Diabetes y Obesidad S. C., Universidad de Guadalajara, Hospital Civil de Guadalajara "Dr. Juan I. Menchaca," Guadalajara, Mexico.
Akane TakamiSanofi, Tokyo, Japan.
Hailing GuoBiostatistics, BMD Consulting Inc., Somerset, NJ.
Elisabeth NiemoellerDiabetes Division, Sanofi, Frankfurt, Germany.
Elisabeth SouhamiDiabetes Division, Sanofi, Paris, France.
Richard M BergenstalInternational Diabetes Center, Park Nicollet Health Services, Minneapolis, MN.
LixiLan-L Trial Investigators
Biostatistical Consulting (United States) · USCatalina Research Institute · USComplexo Hospitalario Universitario A Coruña · ESDallas Diabetes Research Center · USMedStar Health · USPark Nicollet Health Services · USRockwood Clinic · USSanofi (France) · FRSanofi (Germany) · DESanofi (Japan) · JPUniversidad de Guadalajara · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents. RESEARCH DESIGN AND

methodsAfter a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m

resultsHbA

conclusionsCompared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes.

Indexed as

AgedBlood GlucoseBody Mass IndexBody WeightDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDrug CombinationsDrug Evaluation, PreclinicalEndpoint DeterminationFemaleGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin GlargineBlood GlucoseDrug CombinationsGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHypoglycemic AgentsInsulinInsulin GlarginelixisenatideMetforminPeptides

Identifiers

PMID27650977
OpenAlexW2521422828

What Socratic holds

Texttitle and abstract
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.