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Study · Randomized controlled trial · 2015

6 results

Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan.

Seino Y, Yabe D, Takami A, Niemoeller E, Takagi H

Journal of diabetes and its complications6 Jul 2015Cited by 15 (Europe PMC)

PMID26342556 (opens in a new tab)DOI10.1016/j.jdiacomp.2015.07.003 (opens in a new tab)PepBankPUB-26342556
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes, nausea occurred in 12/33 (36.4%) with two-step lixisenatide versus 18/36 (50.0%) with one-step lixisenatide.

    In plain wordsIn Japanese patients with diabetes, nausea was less frequent with two-step lixisenatide than one-step lixisenatide through week 24.

    Peptide
    Lixisenatide
    Outcome
    DecreaseNausea through week 24
    Study

    n: not reported in source

    Comparator
    One-step lixisenatide dose-increase regimen
    Analysis
    Primary
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Patients with nausea
    12 patients
    two-step
    Patients
    33 patients
    two-step
    Incidence
    36.4%
    two-step
    Patients with nausea
    18 patients
    one-step
    Patients
    36 patients
    one-step
    Incidence
    50%
    one-step

    Source sentences

    Summary
    As expected with treatment with a glucagon-like peptide-1 agonist, nausea was the most common treatment-emergent adverse event (2-step group: n=12/33 [36.4%] vs 1-step group: n=18/36 [50.0%] up to week 24).
    2 context sentences
    Summary · context
    This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.
    Summary · context
    Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen.
  2. 02HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes, discontinuation occurred in 5/33 (15.2%) with two-step lixisenatide versus 2/36 (5.6%) with one-step, mainly from adverse events.

    In plain wordsIn Japanese patients with diabetes, discontinuation was more frequent with two-step lixisenatide than one-step through week 24, mainly from side effects.

    Peptide
    Lixisenatide
    Outcome
    IncreasePremature discontinuation through week 24
    Study

    n: not reported in source

    Comparator
    One-step lixisenatide dose-increase regimen
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Discontinuations
    5 patients
    two-step
    Incidence
    15.2%
    two-step
    Discontinuations
    2 patients
    one-step
    Incidence
    5.6%
    one-step

    Source sentences

    Summary
    In total, 5/33 patients (15.2%; 2-step group) and 2/36 patients (5.6%; 1-step group) prematurely discontinued treatment up to week 24, mainly due to adverse events.
    2 context sentences
    Summary · context
    This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.
    Summary · context
    Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen.
  3. 03HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes, serious events occurred in 2/33 (6.1%) with two-step lixisenatide versus 0/36 (0%) with one-step.

    In plain wordsIn Japanese patients with diabetes, serious side effects were more frequent with two-step lixisenatide than one-step through week 24.

    Peptide
    Lixisenatide
    Outcome
    IncreaseSerious treatment-emergent adverse events through week 24
    Study

    n: not reported in source

    Comparator
    One-step lixisenatide dose-increase regimen
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Patients with serious events
    2 patients
    two-step
    Incidence
    6.1%
    two-step
    Patients with serious events
    0 patients
    one-step
    Incidence
    0%
    one-step

    Source sentences

    Summary
    Serious treatment-emergent adverse events occurred in 2/33 patients (6.1%; 2-step group) versus 0/36 patients (0%; 1-step group) up to week 24.
    2 context sentences
    Summary · context
    This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.
    Summary · context
    Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen.
  4. 04HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes, symptomatic hypoglycemia occurred in 2/33 (6.1%) with two-step lixisenatide versus 1/36 (2.8%) with one-step.

    In plain wordsIn Japanese patients with diabetes, low blood sugar symptoms were more frequent with two-step lixisenatide than one-step through week 24.

    Peptide
    Lixisenatide
    Outcome
    IncreaseSymptomatic hypoglycemia through week 24
    Study

    n: not reported in source

    Comparator
    One-step lixisenatide dose-increase regimen
    Analysis
    Primary
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Patients with symptomatic hypoglycemia
    2 patients
    two-step
    Incidence
    6.1%
    two-step
    Patients with symptomatic hypoglycemia
    1 patients
    one-step
    Incidence
    2.8%
    one-step

    Source sentences

    Summary
    Symptomatic hypoglycemia occurred in 2/33 patients (6.1%; 2-step group) versus 1/36 patients (2.8%; 1-step group) up to week 24, with no severe events reported.
    2 context sentences
    Summary · context
    This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.
    Summary · context
    Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen.
  5. 05HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes, no severe hypoglycemia occurred with either lixisenatide dose-increase regimen through week 24.

    In plain wordsIn Japanese patients with diabetes, neither lixisenatide dose-increase regimen had severe low blood sugar events through week 24.

    Peptide
    Lixisenatide
    Outcome
    No significant changeSevere hypoglycemia through week 24
    Study

    n: not reported in source

    Comparator
    One-step lixisenatide dose-increase regimen
    Analysis
    Primary
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Symptomatic hypoglycemia occurred in 2/33 patients (6.1%; 2-step group) versus 1/36 patients (2.8%; 1-step group) up to week 24, with no severe events reported.
    2 context sentences
    Summary · context
    This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.
    Summary · context
    Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen.
  6. 06HumanNon-randomized trialEfficacy outcome

    In Japanese patients with diabetes, glycated hemoglobin, fasting glucose and body weight decreased from baseline with lixisenatide at weeks 24 and 76.

    In plain wordsIn Japanese patients with diabetes, glycated hemoglobin, fasting blood sugar and weight decreased from baseline with lixisenatide at weeks 24 and 76.

    Peptide
    Lixisenatide
    Outcome
    DecreaseGlycated hemoglobin, fasting glucose and body weight at weeks 24 and 76
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Glycated hemoglobin, fasting plasma glucose, and body weight were reduced from baseline at weeks 24 and 76.
    2 context sentences
    Summary · context
    This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.
    Summary · context
    Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen.

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00905255

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS)

Sanofin = 69May 2009 to Jan 2011

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 21 Dec 2016

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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