Evidence map›Paper›PMID 31050109›Full record

Trial reportDiabetes, obesity & metabolism2019

Effect of a single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase I randomized trial.

Megumi Inoue, Martin Lorenz, Hideya Muto, Roland Wesch, Yasuhiro Hashimoto

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02713477 (A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 26% 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.

NCT02713477 phase1completednot on this map

A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

TypeinterventionalSponsorSanofiRan2016 to 2016Enrolled20ConditionsType 2 Diabetes MellitusArmsInsulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010, Insulin glargine HOE901, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. 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
  5. Article
  6. 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

5 authors at 3 institutions in 3 countries.

Megumi InoueSOUSEIKAI PS Clinic, Fukuoka, Japan.
Martin LorenzResearch & Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
Hideya MutoResearch & Development, Sanofi K.K., Tokyo, Japan.ORCID 0000-0001-7275-5187
Roland WeschResearch & Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
Yasuhiro HashimotoResearch & Development, Sanofi K.K., Tokyo, Japan.
Sanofi (France) · FRSanofi (Japan) · JPSOUSEIKAI Global Clinical Research Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This report describes novel clinical data assessing the pharmacodynamics of insulin glargine/lixisenatide (iGlarLixi) compared with placebo and insulin glargine alone, to determine pharmacokinetics of lixisenatide, and to assess safety of iGlarLixi in Japanese people with type 2 diabetes mellitus (T2DM). In a single-centre, open-label, randomized, placebo-controlled cross-over study, participants received subcutaneous iGlarLixi 5 U/5 μg and 10 U/10 μg, placebo, and 5 U insulin glargine. The primary endpoint was area under the postprandial plasma glucose (PPG) curve (AUC

Indexed as

AdultBlood GlucoseCross-Over StudiesDiabetes Mellitus, Type 2Drug CombinationsFemaleGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin GlargineJapanMaleMiddle AgedPeptidesBlood GlucoseDrug CombinationsGlucagon-Like Peptide-2 ReceptorGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin GlarginelixisenatidePeptidesbasal insulinGLP-1 analogueglycaemic controlpharmacodynamicspharmacokineticsphase I-II study

Identifiers

PMID31050109
PMCPMC6771557
OpenAlexW2943099799

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.