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Study · Randomized controlled trial · n = 20 · 2019

2 results

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.

Inoue M, Lorenz M, Muto H, Wesch R, Hashimoto Y

Diabetes, obesity & metabolism24 May 2019Cited by 9 (Europe PMC)

PMID31050109 (opens in a new tab)PMCIDPMC6771557 (opens in a new tab)DOI10.1111/dom.13757 (opens in a new tab)PepBankPUB-31050109
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Summary

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 (AUC0-2h ). A total of 20 participants completed all study periods. iGlarLixi 5 U/5 μg and 10 U/10 μg reduced mean PPG dose-dependently compared with placebo and insulin glargine 5 U. Both combinations significantly reduced PPG-AUC0-2h dose-dependently compared with placebo (least squares mean difference -7.48 mmol h/L for 5 U/5 μg, -10.75 mmol h/L for 10 U/10 μg; P < 0.0001). iGlarLixi 5 U/5 μg reduced PPG-AUC0-2h significantly compared with insulin glargine 5 U (-0.76 mmol h/L; P < 0.0001). No symptomatic hypoglycaemia occurred during the study. iGlarLixi single subcutaneous injections significantly and dose-dependently reduced PPG compared to placebo or insulin glargine in Japanese participants with T2DM. iGlarLixi was safe and well tolerated, and would be expected to provide the 24-hour plasma glucose-lowering effects of insulin glargine and the postprandial antihyperglycaemic effects of lixisenatide.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with diabetes, iGlarLixi 5 U/5 μg reduced PPG-AUC versus insulin glargine 5 U by -0.76 mmol h/L (P < 0.0001).

    In plain wordsIn Japanese participants with diabetes, iGlarLixi 5 U/5 μg reduced glucose AUC after meals versus insulin glargine 5 U.

    Peptide
    Lixisenatide
    Outcome
    DecreasePostprandial plasma glucose AUC
    Study

    n = 20

    Comparator
    Insulin glargine 5 U
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 μg in iGlarLixi 5 U/5 μg · subcutaneous · single doseAs given in this study (human).

    Measurements

    PPG-AUC difference
    −0.76 mmol h/L
    iGlarLixi 5 U/5 μg versus insulin glargine 5 U

    Source sentences

    Summary
    iGlarLixi 5 U/5 μg reduced PPG-AUC0-2h significantly compared with insulin glargine 5 U (-0.76 mmol h/L; P < 0.0001).
    2 context sentences
    Summary · context
    The primary endpoint was area under the postprandial plasma glucose (PPG) curve (AUC0-2h ).
    Summary · context
    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.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with diabetes, iGlarLixi 5 U/5 μg reduced mean postprandial glucose versus insulin glargine 5 U.

    In plain wordsIn Japanese participants with diabetes, iGlarLixi 5 U/5 μg reduced mean glucose after meals versus insulin glargine 5 U.

    Peptide
    Lixisenatide
    Outcome
    DecreaseMean postprandial plasma glucose
    Study

    n = 20

    Comparator
    Insulin glargine 5 U
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 μg in iGlarLixi 5 U/5 μg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    A total of 20 participants completed all study periods. iGlarLixi 5 U/5 μg and 10 U/10 μg reduced mean PPG dose-dependently compared with placebo and insulin glargine 5 U.
    1 context sentence
    Summary · context
    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.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02713477

Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

Sanofin = 20Apr 2016 to Jun 2016

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 16 Jun 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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