Evidence map›Paper›PMID 32295808›Full record

Trial reportDiabetes care2020

Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial.

Hirotaka Watada, Akane Takami, Robert Spranger, Atsushi Amano, Yasuhiro Hashimoto, Elisabeth Niemoeller

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02749890 (A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 8% 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.

NCT02749890 phase3completednot on this map

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period

TypeinterventionalSponsorSanofiRan2016 to 2018Enrolled321ConditionsType 2 Diabetes MellitusArmsInsulin glargine/Lixisenatide (HOE901/AVE0010), Lixisenatide (AVE0010), Oral anti-diabetic drugs
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Article
  9. Observational
  10. Article
  11. The Current and Future Role of Insulin Therapy in the Management of Type 2 Diabetes: A Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Review
  12. Impact of Participant Characteristics on Clinical Outcomes with iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of SPARTA Japan.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Article
  13. Pharmacokinetics and Safety of iGlarLixi in Healthy Chinese Participants: Results of a Phase 1 Randomized Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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

6 authors at 3 institutions in 2 countries.

Hirotaka WatadaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan hwatada@juntendo.ac.jp.ORCID 0000-0001-5961-1816
Akane TakamiResearch & Development, Sanofi K.K., Tokyo, Japan.
Robert SprangerDiabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
Atsushi AmanoResearch & Development, Sanofi K.K., Tokyo, Japan.
Yasuhiro HashimotoResearch & Development, Sanofi K.K., Tokyo, Japan.
Elisabeth NiemoellerDiabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
Sanofi (Japan) · JPSanofi (Germany) · DEJuntendo University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs). RESEARCH DESIGN AND

methodsIn this phase 3, open-label, multicenter trial, 321 patients with HbA

resultsChange in HbA

conclusionsThis phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.

Indexed as

Administration, OralAgedBlood GlucoseDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDrug CombinationsDrug ResistanceFemaleGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin GlargineJapanMaleBlood GlucoseDrug CombinationsGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHypoglycemic AgentsInsulin GlarginelixisenatidePeptides

Identifiers

PMID32295808
PMCPMC7245357
OpenAlexW3016289287

What Socratic holds

Textmetadata
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.