Evidence mapPaperPMID 29923298Full record

Trial reportDiabetes, obesity & metabolism2018

Low incidence of gastrointestinal adverse events over time with a fixed-ratio combination of insulin glargine and lixisenatide versus lixisenatide alone.

Jennifer M Trujillo, Michelle Roberts, Terry Dex, Jason Chao, John White, James LaSalle

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02058147. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.0field-weighted citation impact, top 13% 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.

NCT02058147 phase3completed

A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

Ran2014Enrolled1,170Registered outcomes15Posted comparisons15ConditionsType 2 DiabetesArmsInsulin glargine (HOE901), Insulin glargine/lixisenatide Fixed Ratio Combination, Lixisenatide (AVE0010), Metformin
PMID 27527848other papers from this trial
Open the trial in the graph
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

12 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
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  4. Review
  5. Article
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  11. Review
  12. A Review of the Safety and Adverse Event Profile of the Fixed-Ratio Combination of Insulin Glargine and Lixisenatide.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Review
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

6 authors at 5 institutions in 1 country.

Jennifer M TrujilloDepartment of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado.ORCID 0000-0001-7898-8029
Michelle RobertsSanofi US, Inc., Bridgewater, New Jersey.
Terry DexSanofi US, Inc., Bridgewater, New Jersey.
Jason ChaoXinyi, Inc., Bridgewater, New Jersey.
John WhiteDepartment of Pharmacy, Washington State University, Spokane, Washington.
James LaSalleExcelsior Springs Clinic, Excelsior Springs, Missouri.
Sanofi (United States) · USBridgewater College · USExcelsior Springs Museum & Archives · USUniversity of Colorado Anschutz Medical Campus · USWashington State University Spokane · US

Funding

Sanofi US Inc.
6 · The paper itself

Abstract

This post hoc analysis of gastrointestinal (GI) adverse events (AEs) from the phase 3 LixiLan-L (NCT02058160) and LixiLan-O (NCT02058147) trials aimed to determine the frequency and timing of nausea, vomiting, and diarrhoea for iGlarLixi, a titratable, fixed-ratio combination of insulin glargine 100 units/mL (iGlar) and lixisenatide, versus iGlar alone or iGlar and lixisenatide alone, in patients with type 2 diabetes uncontrolled with oral antidiabetes drugs (OADs) or basal insulin ± OADs. In iGlarLixi-treated patients, the rate of GI AEs during the initial weeks of treatment was lower versus patients treated with lixisenatide alone (9.6% and 11.7% of iGlarLixi-treated patients in LixiLan-L and LixiLan-O, respectively, vs. 27.5% of lixisenatide-treated patients in LixiLan-O). Beyond day 60, these rates were generally low and similar to those of lixisenatide. These lower rates are likely due to the gradual titration of lixisenatide in iGlarLixi. Median durations of intermittent GI AEs in the iGlarLixi arms were 6.0, 2.0 and 2.5 days (LixiLan-L), and 5.0, 1.0 and 3.5 days (LixiLan-O), respectively. iGlarLixi-associated GI AEs were transient, mostly mild or moderate in severity, and occurred mainly during initial titration.

Indexed as

AdultDiabetes Mellitus, Type 2Drug CombinationsFemaleGastrointestinal DiseasesGlucagon-Like Peptide-2 ReceptorHumansIncidenceInsulin GlargineMalePeptidesPostprandial PeriodRetrospective StudiesDrug CombinationsGlucagon-Like Peptide-2 ReceptorInsulin GlarginelixisenatidePeptidesfixed-ratio combinationgastrointestinal adverse eventsinsulin glarginelixisenatide

Identifiers

PMID29923298
PMCPMC6221077
OpenAlexW2809587600

What Socratic holds

Textmetadata
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.