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Study · Randomized controlled trial · n = 510 · 2013

14 results

Efficacy and safety of lixisenatide once-daily morning or evening injections in type 2 diabetes inadequately controlled on metformin (GetGoal-M).

Ahrén B, Leguizamo Dimas A, Miossec P, Saubadu S, Aronson R

Diabetes care27 Mar 2013Cited by 148 (Europe PMC)

PMID23536584 (opens in a new tab)PMCIDPMC3747937 (opens in a new tab)DOI10.2337/dc12-2006 (opens in a new tab)PepBankPUB-23536584
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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 study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, morning lixisenatide reduced HbA1c by 0.9% versus 0.4% with combined placebo (difference -0.5%, P < 0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseMorning HbA1c
    Study

    n: not reported in source

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

    Measurements

    HbA1c change
    −0.9%
    morning lixisenatide
    HbA1c change
    −0.4%
    combined placebo
    LS mean difference vs placebo
    −0.5%
    morning lixisenatide vs combined placebo
    P value
    < 0.0001 P
    morning lixisenatide vs combined placebo

    Source sentences

    Summary
    Lixisenatide morning injection significantly reduced mean HbA1c versus combined placebo (mean change -0.9% [9.8 mmol/mol] vs. -0.4% [4.4 mmol/mol]; least squares [LS] mean difference vs. placebo -0.5% [5.5 mmol/mol], P < 0.0001).
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, evening lixisenatide reduced HbA1c by 0.8% versus 0.4% with placebo (difference -0.4%, P < 0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseEvening HbA1c
    Study

    n: not reported in source

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

    Measurements

    HbA1c change
    −0.8%
    evening lixisenatide
    HbA1c change
    −0.4%
    placebo
    LS mean difference
    −0.4%
    evening lixisenatide vs placebo
    P value
    < 0.0001 P
    evening lixisenatide vs placebo

    Source sentences

    Summary
    HbA1c was significantly reduced by lixisenatide evening injection (mean change -0.8% [8.7 mmol/mol] vs. -0.4% [4.4 mmol/mol]; LS mean difference -0.4% [4.4 mmol/mol], P < 0.0001).
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, morning lixisenatide changed postprandial glucose by -5.9 versus -1.4 mmol/L with morning placebo (difference -4.5 mmol/L).

    In plain wordsIn patients with diabetes, morning lixisenatide lowered post-meal glucose more than morning placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseMorning postprandial glucose
    Study

    n: not reported in source

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

    Measurements

    2-h postprandial glucose change
    −5.9 mmol/L
    morning lixisenatide
    2-h postprandial glucose change
    −1.4 mmol/L
    morning placebo
    LS mean difference
    −4.5 mmol/L
    morning lixisenatide vs morning placebo
    P value
    < 0.0001 P
    morning lixisenatide vs morning placebo

    Source sentences

    Summary
    Lixisenatide morning injection significantly reduced 2-h postprandial glucose versus morning placebo (mean change -5.9 vs. -1.4 mmol/L; LS mean difference -4.5 mmol/L, P < 0.0001).
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, morning lixisenatide reduced fasting glucose versus placebo by 0.9 mmol/L (P < 0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseMorning fasting glucose
    Study

    n: not reported in source

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

    Measurements

    Fasting plasma glucose LS mean difference
    −0.9 mmol/L
    morning lixisenatide vs placebo
    P value
    < 0.0001 P
    morning lixisenatide vs placebo

    Source sentences

    Summary
    LS mean difference in fasting plasma glucose was significant in both morning (-0.9 mmol/L, P < 0.0001) and evening (-0.6 mmol/L, P = 0.0046) groups versus placebo.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, evening lixisenatide reduced fasting glucose versus placebo by 0.6 mmol/L (P = 0.0046).

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseEvening fasting glucose
    Study

    n: not reported in source

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

    Measurements

    Fasting plasma glucose LS mean difference
    −0.6 mmol/L
    evening lixisenatide vs placebo
    P value
    0.0046 P
    evening lixisenatide vs placebo

    Source sentences

    Summary
    LS mean difference in fasting plasma glucose was significant in both morning (-0.9 mmol/L, P < 0.0001) and evening (-0.6 mmol/L, P = 0.0046) groups versus placebo.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with diabetes, adverse events occurred in 69.4% with morning lixisenatide versus 60.0% with placebo.

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseMorning adverse events
    Study

    n: not reported in source

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

    Measurements

    Adverse events
    69.4%
    morning lixisenatide
    Adverse events
    60%
    placebo

    Source sentences

    Summary
    Rates of adverse events were 69.4% in both lixisenatide groups and 60.0% in the placebo group.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  7. 07HumanRandomized controlled trialSafety outcome

    In patients with diabetes, adverse events occurred in 69.4% with evening lixisenatide versus 60.0% with placebo.

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseEvening adverse events
    Study

    n: not reported in source

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

    Measurements

    Adverse events
    69.4%
    evening lixisenatide
    Adverse events
    60%
    placebo

    Source sentences

    Summary
    Rates of adverse events were 69.4% in both lixisenatide groups and 60.0% in the placebo group.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  8. 08HumanRandomized controlled trialSafety outcome

    In patients with diabetes, nausea occurred in 22.7% with morning lixisenatide versus 7.6% with placebo.

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseMorning nausea
    Study

    n: not reported in source

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

    Measurements

    Nausea
    22.7%
    morning lixisenatide
    Nausea
    7.6%
    placebo

    Source sentences

    Summary
    Rates for nausea and vomiting were 22.7 and 9.4% for lixisenatide morning and 21.2 and 13.3% for lixisenatide evening versus 7.6 and 2.9% for placebo, respectively.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  9. 09HumanRandomized controlled trialSafety outcome

    In patients with diabetes, nausea occurred in 21.2% with evening lixisenatide versus 7.6% with placebo.

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseEvening nausea
    Study

    n: not reported in source

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

    Measurements

    Nausea
    21.2%
    evening lixisenatide
    Nausea
    7.6%
    placebo

    Source sentences

    Summary
    Rates for nausea and vomiting were 22.7 and 9.4% for lixisenatide morning and 21.2 and 13.3% for lixisenatide evening versus 7.6 and 2.9% for placebo, respectively.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  10. 10HumanRandomized controlled trialSafety outcome

    In patients with diabetes, vomiting occurred in 9.4% with morning lixisenatide versus 2.9% with placebo.

    In plain wordsIn patients with diabetes, vomiting was more frequent with morning lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseMorning vomiting
    Study

    n: not reported in source

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

    Measurements

    Vomiting
    9.4%
    morning lixisenatide
    Vomiting
    2.9%
    placebo

    Source sentences

    Summary
    Rates for nausea and vomiting were 22.7 and 9.4% for lixisenatide morning and 21.2 and 13.3% for lixisenatide evening versus 7.6 and 2.9% for placebo, respectively.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  11. 11HumanRandomized controlled trialSafety outcome

    In patients with diabetes, vomiting occurred in 13.3% with evening lixisenatide versus 2.9% with placebo.

    In plain wordsIn patients with diabetes, vomiting was more frequent with evening lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseEvening vomiting
    Study

    n: not reported in source

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

    Measurements

    Vomiting
    13.3%
    evening lixisenatide
    Vomiting
    2.9%
    placebo

    Source sentences

    Summary
    Rates for nausea and vomiting were 22.7 and 9.4% for lixisenatide morning and 21.2 and 13.3% for lixisenatide evening versus 7.6 and 2.9% for placebo, respectively.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  12. 12HumanRandomized controlled trialSafety outcome

    In patients with diabetes, symptomatic hypoglycemia occurred in 6 morning lixisenatide patients versus 1 placebo patient.

    In plain wordsIn patients with diabetes, symptomatic low glucose affected more morning lixisenatide patients than placebo patients.

    Peptide
    Lixisenatide
    Outcome
    IncreaseMorning symptomatic hypoglycemia
    Study

    n: not reported in source

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

    Measurements

    Symptomatic hypoglycemia
    6 patients
    morning lixisenatide
    Symptomatic hypoglycemia
    1 patients
    placebo

    Source sentences

    Summary
    Symptomatic hypoglycemia occurred in 6, 13, and 1 patient for lixisenatide morning, evening, and placebo, respectively, with no severe episodes.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  13. 13HumanRandomized controlled trialSafety outcome

    In patients with diabetes, symptomatic hypoglycemia occurred in 13 evening lixisenatide patients versus 1 placebo patient.

    In plain wordsIn patients with diabetes, symptomatic low glucose affected more evening lixisenatide patients than placebo patients.

    Peptide
    Lixisenatide
    Outcome
    IncreaseEvening symptomatic hypoglycemia
    Study

    n: not reported in source

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

    Measurements

    Symptomatic hypoglycemia
    13 patients
    evening lixisenatide
    Symptomatic hypoglycemia
    1 patients
    placebo

    Source sentences

    Summary
    Symptomatic hypoglycemia occurred in 6, 13, and 1 patient for lixisenatide morning, evening, and placebo, respectively, with no severe episodes.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.
  14. 14HumanNon-randomized trialSafety outcome

    In patients with diabetes, no severe hypoglycemia episodes occurred in either lixisenatide timing group.

    In plain wordsIn patients with diabetes, neither lixisenatide timing group had severe low glucose episodes.

    Peptide
    Lixisenatide
    Outcome
    Not applicableSevere hypoglycemia
    Study

    n = 510

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

    Source sentences

    Summary
    Symptomatic hypoglycemia occurred in 6, 13, and 1 patient for lixisenatide morning, evening, and placebo, respectively, with no severe episodes.
    3 context sentences
    Summary · context
    To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.
    Summary · context
    This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10% [53-86 mmol/mol]).
    Summary · context
    Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections.

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 postedNCT00712673

GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Sanofin = 680Jun 2008 to Mar 2011

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 15 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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