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Study · Randomized controlled trial · n = 484 · 2013

8 results

Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).

Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Guo H, Aronson R

Diabetes, obesity & metabolism26 May 2013Cited by 119 (Europe PMC)

PMID23627775 (opens in a new tab)DOI10.1111/dom.12121 (opens in a new tab)PepBankPUB-23627775
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 study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on pioglitazone, lixisenatide reduced HbA1c versus placebo by 0.56% at week 24 (p < 0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c at week 24
    Study

    n = 484

    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

    HbA1c change vs placebo
    −0.56%
    lixisenatide vs placebo
    P value
    < 0.0001 P
    lixisenatide vs placebo

    Source sentences

    Summary
    After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (-0.84 mmol/l vs. placebo; p < 0.0001).
    3 context sentences
    Summary · context
    To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
    Summary · context
    This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period.
    Summary · context
    Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on pioglitazone, HbA1c <7% occurred in 52.3% with lixisenatide versus 26.4% with placebo (p < 0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseHbA1c below 7%
    Study

    n = 484

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

    Measurements

    HbA1c <7% achieved
    52.3%
    lixisenatide
    HbA1c <7% achieved
    26.4%
    placebo
    P value
    < 0.0001 P
    lixisenatide vs placebo

    Source sentences

    Summary
    After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (-0.84 mmol/l vs. placebo; p < 0.0001).
    3 context sentences
    Summary · context
    To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
    Summary · context
    This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period.
    Summary · context
    Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on pioglitazone, lixisenatide reduced fasting glucose versus placebo by 0.84 mmol/l (p < 0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseFasting plasma glucose
    Study

    n = 484

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

    Measurements

    Fasting plasma glucose difference vs placebo
    −0.84 mmol/L
    lixisenatide vs placebo
    P value
    < 0.0001 P
    lixisenatide vs placebo

    Source sentences

    Summary
    After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (-0.84 mmol/l vs. placebo; p < 0.0001).
    3 context sentences
    Summary · context
    To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
    Summary · context
    This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period.
    Summary · context
    Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on pioglitazone, weight decreased with lixisenatide and increased with placebo, without a significant between-group difference.

    In plain wordsIn patients with diabetes on pioglitazone, weight decreased with lixisenatide versus an increase with placebo, without significant difference.

    Peptide
    Lixisenatide
    Outcome
    DecreaseBody weight
    Study

    n = 484

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

    Source sentences

    Summary
    There was a small decrease in body weight with lixisenatide once daily and a small increase with placebo, with no statistically significant difference between the two groups.
    3 context sentences
    Summary · context
    To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
    Summary · context
    This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period.
    Summary · context
    Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo.
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with diabetes on pioglitazone, adverse events occurred in 72.4% with lixisenatide versus 72.7% with placebo, with similar proportions.

    In plain wordsIn patients with diabetes on pioglitazone, adverse events were numerically lower with lixisenatide than placebo, with similar proportions.

    Peptide
    Lixisenatide
    Outcome
    DecreaseTreatment-emergent adverse events
    Study

    n = 484

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

    Measurements

    Treatment-emergent adverse events
    72.4%
    lixisenatide
    Treatment-emergent adverse events
    72.7%
    placebo

    Source sentences

    Summary
    Overall, lixisenatide once daily was well tolerated, with a similar proportion of treatment-emergent adverse events (TEAEs) and serious TEAEs between groups (lixisenatide: 72.4% and 2.5%; placebo: 72.7% and 1.9%).
    3 context sentences
    Summary · context
    To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
    Summary · context
    This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period.
    Summary · context
    Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo.
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with diabetes on pioglitazone, serious adverse events occurred in 2.5% with lixisenatide versus 1.9% with placebo, with similar proportions.

    In plain wordsIn patients with diabetes on pioglitazone, serious events were numerically higher with lixisenatide than placebo, with similar proportions.

    Peptide
    Lixisenatide
    Outcome
    IncreaseSerious adverse events
    Study

    n = 484

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

    Measurements

    Serious treatment-emergent adverse events
    2.5%
    lixisenatide
    Serious treatment-emergent adverse events
    1.9%
    placebo

    Source sentences

    Summary
    Overall, lixisenatide once daily was well tolerated, with a similar proportion of treatment-emergent adverse events (TEAEs) and serious TEAEs between groups (lixisenatide: 72.4% and 2.5%; placebo: 72.7% and 1.9%).
    3 context sentences
    Summary · context
    To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
    Summary · context
    This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period.
    Summary · context
    Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo.
  7. 07HumanRandomized controlled trialSafety outcome

    In patients with diabetes on pioglitazone, symptomatic hypoglycaemia occurred in 3.4% with lixisenatide versus 1.2% with placebo.

    In plain wordsIn patients with diabetes on pioglitazone, symptomatic low glucose was numerically more frequent with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseSymptomatic hypoglycaemia
    Study

    n = 484

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

    Measurements

    Symptomatic hypoglycaemia
    3.4%
    lixisenatide
    Symptomatic hypoglycaemia
    1.2%
    placebo

    Source sentences

    Summary
    Symptomatic hypoglycaemia rates were also relatively low in both groups (lixisenatide 3.4% and placebo 1.2%), with no severe episodes.
    3 context sentences
    Summary · context
    To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
    Summary · context
    This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period.
    Summary · context
    Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo.
  8. 08HumanNon-randomized trialSafety outcome

    In patients with diabetes on pioglitazone, no severe hypoglycaemia episodes occurred with lixisenatide.

    In plain wordsIn patients with diabetes on pioglitazone, no severe low glucose episodes occurred with lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    Not applicableSevere hypoglycaemia
    Study

    n = 323

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

    Source sentences

    Summary
    Symptomatic hypoglycaemia rates were also relatively low in both groups (lixisenatide 3.4% and placebo 1.2%), with no severe episodes.
    3 context sentences
    Summary · context
    To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
    Summary · context
    This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period.
    Summary · context
    Patients were randomized 2 : 1 to receive 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 trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 1/2NCT02308254

Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People

Royal Adelaide Hospitaln = 30Nov 2013 to est. Apr 2016

Diabetes Mellitus · Gastroparesis

Trial pageClinicalTrials.govUpdated 29 Oct 2015
CompletedPhase 3Results postedNCT00763815

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

Sanofin = 484Sept 2008 to Jun 2011

Diabetes Mellitus Type 2

Trial pageClinicalTrials.govUpdated 28 Nov 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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