Evidence map›Paper›PMID 31848983›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2020

Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis.

Ádám G Tabák, John Anderson, Pablo Aschner, Minzhi Liu, Aramesh Saremi, Peter Stella, Francisco J Tinahones, Carol Wysham, Juris J Meier

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01768559. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 10% 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.

NCT01768559 phase3completed

A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

Ran2013Enrolled894Registered outcomes15Posted comparisons3ConditionsType 2 DiabetesArmsInsulin Glargine (Mandatory background drug), Insulin glulisine QD, Insulin glulisine TID, Lixisenatide (AVE0010), Metformin (Background drug)
PMID 27222510other 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Expert Panel Guidance and Narrative Review of Treatment Simplification of Complex Insulin Regimens to Improve Outcomes in Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
    Review
  10. Effectiveness of IGlarLixi, a Fixed-Ratio Combination of Insulin Glargine 100 U/mL and Lixisenatide, in People with Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    Article
  11. Review
  12. Article
  13. Review
  14. Article
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

9 authors at 7 institutions in 5 countries.

Ádám G Tabák1st Department of Medicine, Faculty of Medicine, Semmelweis University, Budapest, Hungary. tabak.adam@med.semmelweis-univ.hu.ORCID http://orcid.org/0000-0002-6234-3936
John AndersonThe Frist Clinic, Nashville, TN, USA.
Pablo AschnerSan Ignacio University Hospital, Javeriana University, Bogotá, Colombia.
Minzhi LiuBDM Consulting, Inc., Somerset, NJ, USA.
Aramesh SaremiSanofi, Bridgewater, NJ, USA.
Peter StellaSanofi-Aventis, Budapest, Hungary.
Francisco J TinahonesServicio de Endocrinología y Nutrición, Instituto de Investigación Biomédica de Málaga (IBIMA), Hospital Universitario Virgen de la Victoria, CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, University of Málaga, Málaga, Spain.
Carol WyshamRockwood Clinic, Spokane, WA, USA.
Juris J MeierSt. Josef Hospital, Ruhr-University Bochum, Bochum, Germany.
Hospital Universitario San Ignacio · COInstituto de Salud Carlos III · ESRockwood Clinic · USSanofi (Hungary) · HUSanofi (United States) · USSemmelweis University · HUSt. Josef-Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBasal-bolus (BB) regimens are generally used to intensify basal insulin therapy in patients with type 2 diabetes (T2D) not meeting glycemic targets. However, drawbacks include multiple injection burden and risk of weight gain and hypoglycemia. A once-daily titratable fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi) may provide a simple, well-tolerated, and efficacious alternative. We compared these treatments in a post hoc propensity score matched analysis using randomized trial data.

methodsFrom the LixiLan-L study, 195 patients who had been randomized to iGlarLixi were matched for age, sex, race, T2D duration, baseline body mass index, glycated hemoglobin (HbA1c), fasting plasma glucose, insulin dose, and metformin use to 195 patients who had been randomized to a BB regimen in the GetGoal Duo-2 trial.

resultsAt study end, estimated treatment differences for reduction in HbA1c and weight change, and ratio of hypoglycemia events per patient-year (BB vs iGlarLixi) were - 0.28% (standard error 0.08, P = 0.0002), - 1.32 kg (standard error 0.30, P < 0.0001), and 2.85 (P < 0.0001), respectively, all favoring iGlarLixi over BB. Also, proportions of patients reaching individual and composite goals (HbA1c < 7% [< 53 mmol/mol], no weight gain, and no hypoglycemia) were higher in the iGlarLixi compared with the BB treatment group. Gastrointestinal side effects were more common with iGlarLixi.

conclusionsIn patients with T2D inadequately controlled on basal insulin, iGlarLixi offers an effective alternative to BB regimen for reducing HbA1c, without increased risk of hypoglycemia and weight gain.

trial registrationClinicalTrials.gov: NCT02058160 (LixiLan-L trial); NCT01768559 (GetGoal Duo-2 trial). Plain language summary available for this article.

Indexed as

HypoglycemiaiGlarLixiInsulin therapyType 2 diabetesWeight control

Identifiers

PMID31848983
PMCPMC6965545
OpenAlexW2996231878

What OpenQuestion holds

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LicenceCC BY-NC
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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.