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Study · Randomized controlled trial · n = 391 · 2014

11 results

Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia).

Yu Pan C, Han P, Liu X, Yan S, Feng P, Zhou Z, Lv X, Tian H, Jin Kui Y, Su B, Shang S, Niemoeller E

Diabetes/metabolism research and reviews1 Nov 2014Cited by 63 (Europe PMC)

PMID24639432 (opens in a new tab)DOI10.1002/dmrr.2541 (opens in a new tab)PepBankPUB-24639432
Publisher pagePubMedAsk about this study
Jump to 11 results

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 Asian patients with type 2 diabetes, lixisenatide reduced HbA1c versus placebo by 0.36% (p = 0.0004).

    In plain wordsIn Asian patients with diabetes, lixisenatide lowered HbA1c more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c
    Study

    n = 391

    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

    LS mean difference
    −0.36%
    lixisenatide versus placebo, HbA1c change from baseline to week 24
    P
    0.0004
    lixisenatide versus placebo

    Source sentences

    Summary
    Lixisenatide significantly reduced HbA1c levels compared with placebo (LS mean difference: -0.36%, p = 0.0004).
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Asian patients with type 2 diabetes, more lixisenatide recipients achieved HbA1c <7% than placebo recipients (p = 0.003).

    In plain wordsIn Asian patients with diabetes, more patients reached the HbA1c target with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseHbA1c below 7%
    Study

    n = 391

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

    Measurements

    P
    0.003
    HbA1c <7% target, lixisenatide versus placebo

    Source sentences

    Summary
    A significantly higher proportion of lixisenatide-treated patients achieved HbA1c targets of <7% (p = 0.003) and ≤6.5% (p = 0.001) versus placebo.
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Asian patients with type 2 diabetes, more lixisenatide recipients achieved HbA1c ≤6.5% than placebo recipients (p = 0.001).

    In plain wordsIn Asian patients with diabetes, more patients reached the lower HbA1c target with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseHbA1c at most 6.5%
    Study

    n = 391

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

    Measurements

    P
    0.001
    HbA1c <=6.5% target, lixisenatide versus placebo

    Source sentences

    Summary
    A significantly higher proportion of lixisenatide-treated patients achieved HbA1c targets of <7% (p = 0.003) and ≤6.5% (p = 0.001) versus placebo.
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Asian patients with type 2 diabetes, lixisenatide reduced 2-h postprandial glucose versus placebo by 4.28 mmol/L (p < 0.0001).

    In plain wordsIn Asian patients with diabetes, lixisenatide lowered glucose after breakfast more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreasePostprandial plasma glucose
    Study

    n = 391

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

    Measurements

    LS mean difference
    −4.28 mmol/L
    2-h postprandial plasma glucose, lixisenatide versus placebo
    P
    < 0.0001
    2-h postprandial plasma glucose, lixisenatide versus placebo

    Source sentences

    Summary
    Lixisenatide was associated with a statistically significant reduction in 2-h postprandial plasma glucose after a standardized breakfast versus placebo (LS mean difference: -4.28 mmol/L, p < 0.0001) and a significant reduction in fasting plasma glucose (p = 0.0109).
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Asian patients with type 2 diabetes, lixisenatide reduced fasting plasma glucose versus placebo (p = 0.0109).

    In plain wordsIn Asian patients with diabetes, lixisenatide lowered fasting glucose more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseFasting plasma glucose
    Study

    n = 391

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

    Measurements

    P
    0.0109
    fasting plasma glucose, lixisenatide versus placebo

    Source sentences

    Summary
    Lixisenatide was associated with a statistically significant reduction in 2-h postprandial plasma glucose after a standardized breakfast versus placebo (LS mean difference: -4.28 mmol/L, p < 0.0001) and a significant reduction in fasting plasma glucose (p = 0.0109).
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Asian patients with diabetes, weight fell by 1.50 kg with lixisenatide versus 1.24 kg with placebo, without significant difference (p = 0.296).

    In plain wordsIn Asian patients with diabetes, weight loss was numerically greater with lixisenatide than placebo, without a significant difference.

    Peptide
    Lixisenatide
    Outcome
    No significant changeBody weight
    Study

    n = 391

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

    Measurements

    Body weight change
    −1.5 kg
    lixisenatide
    Body weight change
    −1.24 kg
    placebo
    P
    0.296
    body weight, lixisenatide versus placebo

    Source sentences

    Summary
    There was no difference in weight loss versus placebo, with a modest reduction in body weight reported for both groups (lixisenatide: -1.50 kg, placebo: -1.24 kg; p = 0.296).
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  7. 07HumanRandomized controlled trialSafety outcome

    In Asian patients with diabetes, adverse events occurred in 64.3% with lixisenatide versus 47.4% with placebo.

    In plain wordsIn Asian patients with diabetes, adverse events were more frequent with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseTreatment-emergent adverse events
    Study

    n = 391

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

    Measurements

    Treatment-emergent adverse events
    64.3%
    lixisenatide
    Treatment-emergent adverse events
    47.4%
    placebo

    Source sentences

    Summary
    The incidence of treatment-emergent adverse events (TEAEs) was 64.3% with lixisenatide versus 47.4% with placebo, with serious TEAEs reported in 1.5% versus 2.1% of patients, respectively.
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  8. 08HumanRandomized controlled trialSafety outcome

    In Asian patients with diabetes, serious adverse events occurred in 1.5% with lixisenatide versus 2.1% with placebo.

    In plain wordsIn Asian patients with diabetes, serious adverse events were numerically less frequent with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseSerious treatment-emergent adverse events
    Study

    n = 391

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

    Measurements

    Serious treatment-emergent adverse events
    1.5%
    lixisenatide
    Serious treatment-emergent adverse events
    2.1%
    placebo

    Source sentences

    Summary
    The incidence of treatment-emergent adverse events (TEAEs) was 64.3% with lixisenatide versus 47.4% with placebo, with serious TEAEs reported in 1.5% versus 2.1% of patients, respectively.
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  9. 09HumanRandomized controlled trialSafety outcome

    In Asian patients with diabetes, nausea occurred in 16.3% with lixisenatide versus 2.6% with placebo.

    In plain wordsIn Asian patients with diabetes, nausea was more frequent with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseNausea
    Study

    n = 391

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

    Measurements

    Nausea
    16.3%
    lixisenatide
    Nausea
    2.6%
    placebo

    Source sentences

    Summary
    The most common TEAE in the lixisenatide group was nausea (16.3% vs 2.6% with placebo).
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  10. 10HumanRandomized controlled trialSafety outcome

    In Asian patients with diabetes, symptomatic hypoglycaemia occurred in 5.6% with lixisenatide versus 2.6% with placebo (p = 0.1321).

    In plain wordsIn Asian patients with diabetes, symptomatic low glucose was numerically more frequent with lixisenatide than placebo, without significance.

    Peptide
    Lixisenatide
    Outcome
    IncreaseSymptomatic hypoglycaemia
    Study

    n = 391

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

    Measurements

    Symptomatic hypoglycaemia
    5.6%
    lixisenatide
    Symptomatic hypoglycaemia
    2.6%
    placebo
    P
    0.1321
    symptomatic hypoglycaemia, lixisenatide versus placebo

    Source sentences

    Summary
    The incidence of symptomatic hypoglycaemia was 5.6% with lixisenatide treatment and 2.6% with placebo (p = 0.1321), with no severe symptomatic hypoglycaemia events reported.
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo.
  11. 11HumanNon-randomized trialSafety outcome

    In Asian patients with diabetes, no severe symptomatic hypoglycaemia events were reported during lixisenatide treatment.

    In plain wordsIn Asian patients with diabetes, no severe symptomatic low glucose events were reported with lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    Not applicableSevere symptomatic hypoglycaemia
    Study

    n: not reported in source

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

    Source sentences

    Summary
    The incidence of symptomatic hypoglycaemia was 5.6% with lixisenatide treatment and 2.6% with placebo (p = 0.1321), with no severe symptomatic hypoglycaemia events reported.
    2 context sentences
    Summary · context
    This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    Summary · context
    In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily 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 postedNCT01169779

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

Sanofin = 391Jul 2010 to Dec 2011

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 13 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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