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Study · Randomized controlled trial · n = 495 · 2013

10 results

Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L).

Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J

Diabetes care29 Apr 2013Cited by 239 (Europe PMC)

PMID23628617 (opens in a new tab)PMCIDPMC3747925 (opens in a new tab)DOI10.2337/dc12-2454 (opens in a new tab)PepBankPUB-23628617
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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 study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, lixisenatide reduced HbA1c versus placebo by 0.4% (95% CI -0.6 to -0.2; P = 0.0002).

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

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c change
    Study

    n = 495

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

    Measurements

    Placebo-corrected HbA1c change from baseline
    −0.4%
    lixisenatide vs placebo
    95% CI
    −0.6 to −0.2%
    lixisenatide vs placebo
    P value
    0.0002 P
    lixisenatide vs placebo

    Source sentences

    Summary
    With lixisenatide, the placebo-corrected change of HbA1c from baseline was -0.4% (95% CI -0.6 to -0.2; P = 0.0002), and mean HbA1c at end point was 7.8%.
    3 context sentences
    Summary · context
    HbA1c reduction from baseline was the primary end point.
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, HbA1c <7.0% occurred in 28% with lixisenatide versus 12% with placebo (P < 0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseHbA1c below 7.0%
    Study

    n = 495

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

    Measurements

    HbA1c <7.0% attained
    28%
    lixisenatide
    HbA1c <7.0% attained
    12%
    placebo
    P value
    < 0.0001 P
    lixisenatide vs placebo

    Source sentences

    Summary
    HbA1c <7.0% (53 mmol/mol) was attained by more lixisenatide (28%) than placebo (12%; P < 0.0001) participants.
    2 context sentences
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, lixisenatide reduced post-breakfast glucose versus placebo by 3.8 mmol/L (P < 0.0001).

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

    Peptide
    Lixisenatide
    Outcome
    DecreasePost-breakfast glucose
    Study

    n = 495

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

    Measurements

    Placebo-corrected post-breakfast plasma glucose reduction
    −3.8 mmol/L
    lixisenatide vs placebo
    P value
    < 0.0001 P
    lixisenatide vs placebo

    Source sentences

    Summary
    Lixisenatide reduced plasma glucose levels after a standardized breakfast (placebo-corrected reduction, -3.8 mmol/L; P < 0.0001); seven-point glucose profiles showed a reduction persisting through the day.
    2 context sentences
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, lixisenatide reduced weight versus placebo by 1.3 kg (P < 0.0001).

    In plain wordsIn patients with diabetes on basal insulin, lixisenatide reduced weight more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseBody weight
    Study

    n = 495

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

    Measurements

    Placebo-corrected change in body weight
    −1.3 kg
    lixisenatide 20 μg vs placebo, 24 weeks

    Source sentences

    Summary
    Reductions in body weight (placebo corrected, -1.3 kg; P < 0.0001) and insulin dosage (-3.7 units/day; P = 0.012) were greater with lixisenatide.
    2 context sentences
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, lixisenatide reduced insulin dosage versus placebo by 3.7 units/day (P = 0.012).

    In plain wordsIn patients with diabetes on basal insulin, lixisenatide reduced insulin dosage more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseInsulin dosage
    Study

    n = 495

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

    Measurements

    Placebo-corrected change in insulin dosage
    −3.7 units/day
    lixisenatide 20 μg vs placebo, 24 weeks

    Source sentences

    Summary
    Reductions in body weight (placebo corrected, -1.3 kg; P < 0.0001) and insulin dosage (-3.7 units/day; P = 0.012) were greater with lixisenatide.
    2 context sentences
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with diabetes on basal insulin, symptomatic hypoglycemia occurred in 28% with lixisenatide versus 22% with placebo.

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

    Peptide
    Lixisenatide
    Outcome
    IncreaseSymptomatic hypoglycemia
    Study

    n = 495

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

    Measurements

    Symptomatic hypoglycemia incidence
    28%
    lixisenatide
    Symptomatic hypoglycemia incidence
    22%
    placebo

    Source sentences

    Summary
    Symptomatic hypoglycemia was 28% for lixisenatide and 22% for placebo; 4 of 328 subjects (1.2%) had severe hypoglycemia with lixisenatide vs. 0 of 167 with placebo.
    2 context sentences
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.
  7. 07HumanRandomized controlled trialSafety outcome

    In patients with diabetes on basal insulin, severe hypoglycemia affected 4 of 328 lixisenatide recipients (1.2%) versus 0 of 167 placebo recipients.

    In plain wordsIn patients with diabetes on basal insulin, severe low glucose occurred with lixisenatide but not placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseSevere hypoglycemia
    Study

    n = 495

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

    Measurements

    Severe hypoglycemia subjects
    4 subjects
    lixisenatide, of 328 subjects
    Severe hypoglycemia incidence
    1.2%
    lixisenatide, 4 of 328 subjects
    Severe hypoglycemia subjects
    0 subjects
    placebo, of 167 subjects

    Source sentences

    Summary
    Symptomatic hypoglycemia was 28% for lixisenatide and 22% for placebo; 4 of 328 subjects (1.2%) had severe hypoglycemia with lixisenatide vs. 0 of 167 with placebo.
    2 context sentences
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.
  8. 08HumanNon-randomized trialSafety outcome

    In patients with diabetes on basal insulin, the main adverse events with lixisenatide were gastrointestinal.

    In plain wordsIn patients with diabetes on basal insulin, digestive events were the main adverse events with lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedGastrointestinal adverse events
    Study

    n = 328

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

    Source sentences

    Summary
    Main adverse events (AEs) with lixisenatide were gastrointestinal.
    2 context sentences
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.
  9. 09HumanNon-randomized trialEfficacy outcome

    In patients with diabetes on basal insulin, mean endpoint HbA1c was 7.8% with lixisenatide.

    In plain wordsIn patients with diabetes on basal insulin, mean final HbA1c was 7.8% with lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    Not applicableEndpoint HbA1c
    Study

    n: not reported in source

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

    Measurements

    Mean HbA1c at end point
    7.8%
    lixisenatide

    Source sentences

    Summary
    With lixisenatide, the placebo-corrected change of HbA1c from baseline was -0.4% (95% CI -0.6 to -0.2; P = 0.0002), and mean HbA1c at end point was 7.8%.
    2 context sentences
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.
  10. 10HumanNon-randomized trialEfficacy outcome

    In patients with diabetes on basal insulin, glucose profiles showed lixisenatide-associated reductions persisting through the day.

    In plain wordsIn patients with diabetes on basal insulin, glucose reductions with lixisenatide persisted through the day.

    Peptide
    Lixisenatide
    Outcome
    DecreaseDaytime glucose profile
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Lixisenatide reduced plasma glucose levels after a standardized breakfast (placebo-corrected reduction, -3.8 mmol/L; P < 0.0001); seven-point glucose profiles showed a reduction persisting through the day.
    2 context sentences
    Summary · context
    Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks.
    Summary · context
    Basal insulin dosage was unchanged except to limit hypoglycemia.

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

CompletedPhase 3Results postedNCT00975286

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

Sanofin = 446Oct 2009 to Aug 2011

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 11 Oct 2016
CompletedPhase 3Results postedNCT00715624

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

Sanofin = 496Jul 2008 to Feb 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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