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Study · Non-randomized trial · n = 159 · 2015

10 results

Efficacy and Safety of Lixisenatide in Japanese Patients with Type 2 Diabetes Insufficiently Controlled with Basal Insulin±Sulfonylurea: A Subanalysis of the GetGoal-L-Asia Study.

Seino Y, Ikeda Y, Niemoeller E, Watanabe D, Takagi H, Yabe D, Inagaki N

Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme3 Jun 2015Cited by 11 (Europe PMC)

PMID26039935 (opens in a new tab)DOI10.1055/s-0035-1549875 (opens in a new tab)PepBankPUB-26039935
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: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In Japanese patients with diabetes, lixisenatide reduced HbA1c versus placebo by 1.1% (12 mmol/mol), p<0.0001.

    In plain wordsIn Japanese patients with diabetes, lixisenatide reduced HbA1c more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c
    Study

    n = 159

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Measurements

    Least squares mean difference
    −1.1%
    versus placebo
    Least squares mean difference
    −12 mmol/mol
    versus placebo
    P
    < 0.0001
    versus placebo

    Source sentences

    Summary
    Once-daily lixisenatide significantly reduced mean HbA1c [least squares mean difference vs. placebo - 1.1% (- 12 mmol/mol); p<0.0001].
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.
  2. 02HumanNon-randomized trialEfficacy outcome

    In Japanese patients with diabetes, HbA1c <7% occurred in 31.4% with lixisenatide versus 2.3% with placebo (p<0.0001).

    In plain wordsIn Japanese patients with diabetes, more lixisenatide patients reached HbA1c <7% than placebo patients.

    Peptide
    Lixisenatide
    Outcome
    IncreaseHbA1c below 7%
    Study

    n = 159

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Measurements

    Responder proportion
    31.4%
    lixisenatide
    Responder proportion
    2.3%
    placebo
    P
    < 0.0001
    versus placebo

    Source sentences

    Summary
    Significantly more patients in the lixisenatide group reached HbA1c targets of < 7% (53 mmol/mol; 31.4 vs. 2.3% for placebo; p<0.0001) and ≤ 6.5% (48 mmol/mol; 12.9 vs. 1.2% for placebo; p=0.0028).
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.
  3. 03HumanNon-randomized trialEfficacy outcome

    In Japanese patients with diabetes, HbA1c ≤6.5% occurred in 12.9% with lixisenatide versus 1.2% with placebo (p=0.0028).

    In plain wordsIn Japanese patients with diabetes, more lixisenatide patients reached HbA1c ≤6.5% than placebo patients.

    Peptide
    Lixisenatide
    Outcome
    IncreaseHbA1c at most 6.5%
    Study

    n = 159

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Measurements

    Responder proportion
    12.9%
    lixisenatide
    Responder proportion
    1.2%
    placebo
    P
    0.0028
    versus placebo

    Source sentences

    Summary
    Significantly more patients in the lixisenatide group reached HbA1c targets of < 7% (53 mmol/mol; 31.4 vs. 2.3% for placebo; p<0.0001) and ≤ 6.5% (48 mmol/mol; 12.9 vs. 1.2% for placebo; p=0.0028).
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.
  4. 04HumanNon-randomized trialEfficacy outcome

    In Japanese patients with diabetes, lixisenatide reduced postprandial glucose versus placebo by 8.64 mmol/l (p<0.0001).

    In plain wordsIn Japanese patients with diabetes, lixisenatide reduced blood sugar after a meal more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseTwo-hour postprandial glucose
    Study

    n = 159

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Measurements

    Least squares mean difference
    −8.64 mmol/l
    versus placebo
    P
    < 0.0001
    versus placebo

    Source sentences

    Summary
    Lixisenatide significantly reduced 2-h postprandial plasma glucose (least squares mean difference vs. placebo-8.64 mmol/l; p<0.0001), glucose excursion (least squares mean difference vs. placebo - 7.80 mmol/l; p<0.0001) and fasting plasma glucose (least squares mean difference vs. placebo - 0.96 mmol/l; p=0.0126).
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.
  5. 05HumanNon-randomized trialEfficacy outcome

    In Japanese patients with diabetes, lixisenatide reduced glucose excursion versus placebo by 7.80 mmol/l (p<0.0001).

    In plain wordsIn Japanese patients with diabetes, lixisenatide reduced the blood sugar rise more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseGlucose excursion
    Study

    n = 159

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Measurements

    Least squares mean difference
    −7.8 mmol/l
    versus placebo
    P
    < 0.0001
    versus placebo

    Source sentences

    Summary
    Lixisenatide significantly reduced 2-h postprandial plasma glucose (least squares mean difference vs. placebo-8.64 mmol/l; p<0.0001), glucose excursion (least squares mean difference vs. placebo - 7.80 mmol/l; p<0.0001) and fasting plasma glucose (least squares mean difference vs. placebo - 0.96 mmol/l; p=0.0126).
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.
  6. 06HumanNon-randomized trialEfficacy outcome

    In Japanese patients with diabetes, lixisenatide reduced fasting glucose versus placebo by 0.96 mmol/l (p=0.0126).

    In plain wordsIn Japanese patients with diabetes, lixisenatide reduced fasting blood sugar more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseFasting plasma glucose
    Study

    n = 159

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Measurements

    Least squares mean difference
    −0.96 mmol/l
    versus placebo
    P
    0.0126
    versus placebo

    Source sentences

    Summary
    Lixisenatide significantly reduced 2-h postprandial plasma glucose (least squares mean difference vs. placebo-8.64 mmol/l; p<0.0001), glucose excursion (least squares mean difference vs. placebo - 7.80 mmol/l; p<0.0001) and fasting plasma glucose (least squares mean difference vs. placebo - 0.96 mmol/l; p=0.0126).
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.
  7. 07HumanNon-randomized trialEfficacy outcome

    In Japanese patients with diabetes, weight decreased with lixisenatide without a significant difference versus placebo.

    In plain wordsIn Japanese patients with diabetes, weight decreased with lixisenatide, but the difference versus placebo was not significant.

    Peptide
    Lixisenatide
    Outcome
    No significant changeBody weight versus placebo
    Study

    n = 159

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Body weight was reduced with lixisenatide but with no significant difference vs. placebo.
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.
  8. 08HumanNon-randomized trialSafety outcome

    In Japanese patients with diabetes, gastrointestinal events occurred in 61.1% with lixisenatide versus 11.5% with placebo, generally transient and mild-to-moderate.

    In plain wordsIn Japanese patients with diabetes, digestive side effects were more frequent with lixisenatide than placebo, generally brief and mild-to-moderate.

    Peptide
    Lixisenatide
    Outcome
    IncreaseGastrointestinal adverse events
    Study

    n = 159

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Measurements

    Incidence
    61.1%
    lixisenatide
    Incidence
    11.5%
    placebo

    Source sentences

    Summary
    Gastrointestinal adverse events were more frequent with lixisenatide (61.1 vs. 11.5% for placebo) but were generally transient and mild-to-moderate in intensity.
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.
  9. 09HumanNon-randomized trialSafety outcome

    In Japanese patients receiving sulfonylureas, symptomatic hypoglycemia occurred in 39.0% with lixisenatide versus 13.5% with placebo.

    In plain wordsIn Japanese patients receiving sulfonylureas, low blood sugar symptoms were more frequent with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseSymptomatic hypoglycemia with sulfonylureas
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Measurements

    Incidence
    39%
    lixisenatide with sulfonylureas
    Incidence
    13.5%
    placebo with sulfonylureas

    Source sentences

    Summary
    The incidence of symptomatic hypoglycemia was 39.0 vs. 13.5% in patients receiving sulfonylureas and 32.3 vs. 22.9% in those not receiving sulfonylureas, for lixisenatide and placebo, respectively.
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.
  10. 10HumanNon-randomized trialSafety outcome

    In Japanese patients without sulfonylureas, symptomatic hypoglycemia occurred in 32.3% with lixisenatide versus 22.9% with placebo.

    In plain wordsIn Japanese patients without sulfonylureas, low blood sugar symptoms were more frequent with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseSymptomatic hypoglycemia without sulfonylureas
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    20 μg once daily · 24 weeksAs given in this study (human).

    Measurements

    Incidence
    32.3%
    lixisenatide without sulfonylureas
    Incidence
    22.9%
    placebo without sulfonylureas

    Source sentences

    Summary
    The incidence of symptomatic hypoglycemia was 39.0 vs. 13.5% in patients receiving sulfonylureas and 32.3 vs. 22.9% in those not receiving sulfonylureas, for lixisenatide and placebo, respectively.
    1 context sentence
    Summary · context
    The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo.

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 postedNCT00866658

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea (GETGOAL-L-ASIA)

Sanofin = 311Mar 2009 to Jun 2010

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 11 Oct 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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