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Study · Randomized controlled trial · n = 127 · 2015

11 results

Efficacy and safety of lixisenatide in Japanese patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin: Subanalysis of GetGoal-S.

Onishi Y, Niemoeller E, Ikeda Y, Takagi H, Yabe D, Seino Y

Journal of diabetes investigation24 Sept 2014Cited by 12 (Europe PMC)

PMID25802728 (opens in a new tab)PMCIDPMC4364855 (opens in a new tab)DOI10.1111/jdi.12275 (opens in a new tab)PepBankPUB-25802728
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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. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with diabetes, lixisenatide reduced glycated hemoglobin versus placebo by 1.1% at week 24 (P < 0.0001).

    In plain wordsIn Japanese patients with diabetes, lixisenatide reduced glycated hemoglobin more than placebo at week 24.

    Peptide
    Lixisenatide
    Outcome
    DecreaseGlycated hemoglobin
    Study

    n = 127

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

    Measurements

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

    Source sentences

    Summary
    At week 24, lixisenatide significantly reduced mean glycated hemoglobin (least squares mean difference vs the placebo -1.1% [12 mmol/mol, P < 0.0001]), and significantly more lixisenatide patients reached glycated hemoglobin targets of <7% (53 mmol/mol) and ≤6.5% (48 mmol/mol) vs the placebo.
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with diabetes, significantly more lixisenatide patients reached glycated hemoglobin <7% than placebo patients.

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseGlycated hemoglobin below 7%
    Study

    n = 127

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

    Source sentences

    Summary
    At week 24, lixisenatide significantly reduced mean glycated hemoglobin (least squares mean difference vs the placebo -1.1% [12 mmol/mol, P < 0.0001]), and significantly more lixisenatide patients reached glycated hemoglobin targets of <7% (53 mmol/mol) and ≤6.5% (48 mmol/mol) vs the placebo.
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with diabetes, significantly more lixisenatide patients reached glycated hemoglobin ≤6.5% than placebo patients.

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseGlycated hemoglobin at most 6.5%
    Study

    n = 127

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

    Source sentences

    Summary
    At week 24, lixisenatide significantly reduced mean glycated hemoglobin (least squares mean difference vs the placebo -1.1% [12 mmol/mol, P < 0.0001]), and significantly more lixisenatide patients reached glycated hemoglobin targets of <7% (53 mmol/mol) and ≤6.5% (48 mmol/mol) vs the placebo.
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with diabetes, lixisenatide reduced postprandial glucose versus placebo by 8.51 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 = 127

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

    Measurements

    Least squares mean difference
    −8.51 mmol/L
    versus placebo
    P
    < 0.0001
    versus placebo

    Source sentences

    Summary
    Lixisenatide produced statistically significant reductions in 2-h postprandial plasma glucose (least squares mean difference vs the placebo -8.51 mmol/L, P < 0.0001) and glucose excursion vs the placebo, and significantly reduced fasting plasma glucose (least squares mean difference vs the placebo -…
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with diabetes, lixisenatide significantly reduced glucose excursion versus placebo.

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseGlucose excursion
    Study

    n = 127

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

    Source sentences

    Summary
    Lixisenatide produced statistically significant reductions in 2-h postprandial plasma glucose (least squares mean difference vs the placebo -8.51 mmol/L, P < 0.0001) and glucose excursion vs the placebo, and significantly reduced fasting plasma glucose (least squares mean difference vs the placebo -…
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with diabetes, lixisenatide reduced fasting glucose versus placebo by 0.65 mmol/L (P = 0.0454).

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseFasting plasma glucose
    Study

    n = 127

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

    Measurements

    Least squares mean difference
    −0.65 mmol/L
    versus placebo
    P
    0.0454
    versus placebo

    Source sentences

    Summary
    Lixisenatide produced statistically significant reductions in 2-h postprandial plasma glucose (least squares mean difference vs the placebo -8.51 mmol/L, P < 0.0001) and glucose excursion vs the placebo, and significantly reduced fasting plasma glucose (least squares mean difference vs the placebo -…
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  7. 07HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes, adverse event incidence was similar with lixisenatide and placebo, at 84.2% and 82.4%.

    In plain wordsIn Japanese patients with diabetes, overall side effects were similar with lixisenatide and placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseOverall adverse events
    Study

    n = 127

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 μg/day · 24 weeksAs given in this study (human).

    Measurements

    Incidence
    84.2%
    lixisenatide
    Incidence
    82.4%
    placebo

    Source sentences

    Summary
    The overall incidence of adverse events was similar for lixisenatide and the placebo (84.2 and 82.4%, respectively), the most frequent being gastrointestinal disorders (52.6% for lixisenatide vs 29.4% for placebo).
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  8. 08HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes, gastrointestinal disorders occurred in 52.6% with lixisenatide versus 29.4% with placebo.

    In plain wordsIn Japanese patients with diabetes, digestive disorders were more frequent with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseGastrointestinal disorders
    Study

    n = 127

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

    Measurements

    Incidence
    52.6%
    lixisenatide
    Incidence
    29.4%
    placebo

    Source sentences

    Summary
    The overall incidence of adverse events was similar for lixisenatide and the placebo (84.2 and 82.4%, respectively), the most frequent being gastrointestinal disorders (52.6% for lixisenatide vs 29.4% for placebo).
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  9. 09HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes, symptomatic hypoglycemia occurred in 17.1% with lixisenatide versus 9.8% with placebo.

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseSymptomatic hypoglycemia
    Study

    n = 127

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

    Measurements

    Incidence
    17.1%
    lixisenatide
    Incidence
    9.8%
    placebo

    Source sentences

    Summary
    The incidence of symptomatic hypoglycemia was higher with lixisenatide vs the placebo (17.1 and 9.8%, respectively), with no cases of severe symptomatic hypoglycemia in either group.
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  10. 10HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes, neither lixisenatide nor placebo patients had severe symptomatic hypoglycemia.

    In plain wordsIn Japanese patients with diabetes, neither lixisenatide nor placebo patients had severe low blood sugar symptoms.

    Peptide
    Lixisenatide
    Outcome
    No significant changeSevere symptomatic hypoglycemia
    Study

    n = 127

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

    Source sentences

    Summary
    The incidence of symptomatic hypoglycemia was higher with lixisenatide vs the placebo (17.1 and 9.8%, respectively), with no cases of severe symptomatic hypoglycemia in either group.
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.
  11. 11HumanNon-randomized trialEfficacy outcome

    In Japanese patients with diabetes, bodyweight decreased by 1.12 kg with lixisenatide and by 1.02 kg with placebo.

    In plain wordsIn Japanese patients with diabetes, weight decreased from baseline in both lixisenatide and placebo groups.

    Peptide
    Lixisenatide
    Outcome
    DecreaseBodyweight change
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    20 μg/day · 24 weeksAs given in this study (human).

    Measurements

    Least squares mean change
    −1.12 kg
    lixisenatide
    Least squares mean change
    −1.02 kg
    placebo

    Source sentences

    Summary
    Bodyweight decreased with both lixisenatide and the placebo (least squares mean change -1.12 kg for lixisenatide, -1.02 kg for placebo).
    1 context sentence
    Summary · context
    In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo.

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

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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