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Study · Randomized controlled trial · 2014

11 results

Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S).

Rosenstock J, Hanefeld M, Shamanna P, Min KW, Boka G, Miossec P, Zhou T, Muehlen-Bartmer I, Ratner RE

Journal of diabetes and its complications28 Jan 2014Cited by 107 (Europe PMC)

PMID24650952 (opens in a new tab)DOI10.1016/j.jdiacomp.2014.01.012 (opens in a new tab)PepBankPUB-24650952
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 patients with type 2 diabetes, HbA1c changed by -0.85% with lixisenatide versus -0.10% with placebo (p<0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c
    Study

    n: not reported in source

    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 HbA1c change
    −0.85%
    lixisenatide, week 24
    LS mean HbA1c change
    −0.1%
    placebo, week 24
    P
    < 0.0001
    HbA1c change, lixisenatide versus placebo

    Source sentences

    Summary
    Lixisenatide provided a significant reduction in HbA1c at Week 24 versus placebo (LS mean: -0.85% vs. -0.10%; p<0.0001) and more patients achieved HbA1c <7.0% (36.4% vs. 13.5%; p<0.0001).
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes, HbA1c <7.0% occurred in 36.4% with lixisenatide versus 13.5% with placebo (p<0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseHbA1c below 7.0%
    Study

    n: not reported in source

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

    Measurements

    Patients achieving HbA1c <7.0%
    36.4%
    lixisenatide
    Patients achieving HbA1c <7.0%
    13.5%
    placebo
    P
    < 0.0001
    HbA1c <7.0% attainment, lixisenatide versus placebo

    Source sentences

    Summary
    Lixisenatide provided a significant reduction in HbA1c at Week 24 versus placebo (LS mean: -0.85% vs. -0.10%; p<0.0001) and more patients achieved HbA1c <7.0% (36.4% vs. 13.5%; p<0.0001).
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes, lixisenatide significantly lowered fasting plasma glucose versus placebo.

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseFasting plasma glucose
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Lixisenatide significantly lowered FPG and body weight versus placebo.
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes, lixisenatide significantly lowered body weight versus placebo.

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseBody weight
    Study

    n: not reported in source

    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
    Lixisenatide significantly lowered FPG and body weight versus placebo.
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In breakfast-test patients with diabetes, glucose changed by -111.48 versus -3.80 mg/dL with lixisenatide versus placebo (p<0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    DecreasePostprandial glucose
    Study

    n: not reported in source

    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 2-h PPG change
    −111.48 mg/dL
    lixisenatide, breakfast meal test patients
    LS mean 2-h PPG change
    −3.8 mg/dL
    placebo, breakfast meal test patients
    LS mean 2-h PPG change
    −6.19 mmol/L
    lixisenatide, breakfast meal test patients
    LS mean 2-h PPG change
    −0.21 mmol/L
    placebo, breakfast meal test patients
    P
    < 0.0001
    2-h PPG change, lixisenatide versus placebo

    Source sentences

    Summary
    In breakfast meal test patients, lixisenatide reduced 2-hour PPG versus placebo (LS mean: -111.48 vs. -3.80 mg/dL [-6.19 vs. -0.21 mmol/L]; p<0.0001)
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In breakfast-test patients with diabetes, glucose excursion changed by -94.11 versus +6.24 mg/dL with lixisenatide versus placebo.

    In plain wordsIn breakfast-test patients with diabetes, lixisenatide reduced the glucose rise more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseGlucose excursion
    Study

    n: not reported in source

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

    Measurements

    Glucose excursion change
    −94.11 mg/dL
    lixisenatide, breakfast meal test patients
    Glucose excursion change
    6.24 mg/dL
    placebo, breakfast meal test patients
    Glucose excursion change
    −5.22 mmol/L
    lixisenatide, breakfast meal test patients
    Glucose excursion change
    0.35 mmol/L
    placebo, breakfast meal test patients

    Source sentences

    Summary
    and glucose excursion (-94.11 vs. +6.24 mg/dL [-5.22 vs. +0.35 mmol/L])
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In breakfast-test patients with diabetes, lixisenatide reduced 2-hour glucagon, insulin, proinsulin, and C-peptide versus placebo.

    In plain wordsIn breakfast-test patients with diabetes, lixisenatide reduced the listed post-meal hormones versus placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreasePostprandial hormones
    Study

    n: not reported in source

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

    Source sentences

    Summary
    and reduced 2-hour glucagon, insulin, proinsulin, and C-peptide.
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  8. 08HumanRandomized controlled trialSafety outcome

    In patients with diabetes, adverse events occurred in 68.3% with lixisenatide versus 61.1% with placebo.

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseAdverse events
    Study

    n: not reported in source

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

    Measurements

    Adverse events
    68.3%
    lixisenatide
    Adverse events
    61.1%
    placebo

    Source sentences

    Summary
    The percentage of AEs was 68.3% for lixisenatide and 61.1% for placebo; and for SAEs: 3.5% versus 5.6%, respectively.
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  9. 09HumanRandomized controlled trialSafety outcome

    In patients with diabetes, serious adverse events occurred in 3.5% with lixisenatide versus 5.6% with placebo.

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseSerious adverse events
    Study

    n: not reported in source

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

    Measurements

    Serious adverse events
    3.5%
    lixisenatide
    Serious adverse events
    5.6%
    placebo

    Source sentences

    Summary
    The percentage of AEs was 68.3% for lixisenatide and 61.1% for placebo; and for SAEs: 3.5% versus 5.6%, respectively.
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  10. 10HumanRandomized controlled trialSafety outcome

    In patients with diabetes, symptomatic hypoglycemia occurred in 15.3% with lixisenatide versus 12.3% with placebo, without significant increase.

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

    Peptide
    Lixisenatide
    Outcome
    No significant changeSymptomatic hypoglycemia
    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

    Symptomatic hypoglycemia
    15.3%
    lixisenatide
    Symptomatic hypoglycemia
    12.3%
    placebo

    Source sentences

    Summary
    Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo (15.3% vs. 12.3%, respectively); one severe episode of hypoglycemia was reported with lixisenatide.
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.
  11. 11HumanNon-randomized trialSafety outcome

    In patients with diabetes, one severe hypoglycemia episode was reported with lixisenatide.

    In plain wordsIn patients with diabetes, one severe low glucose episode occurred with lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    Not applicableSevere hypoglycemia
    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).

    Measurements

    Severe hypoglycemia episodes
    1 episode
    lixisenatide

    Source sentences

    Summary
    Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo (15.3% vs. 12.3%, respectively); one severe episode of hypoglycemia was reported with lixisenatide.
    2 context sentences
    Summary · context
    To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.
    Summary · context
    In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin.

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 postedNCT00713830

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea

Sanofin = 859Jul 2008 to Jan 2011

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 14 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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