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Study · Non-randomized trial · n = 18 · 2022

13 results

A study on pharmacokinetics, pharmacodynamics and safety of lixisenatide in children and adolescents with type 2 diabetes.

Barrientos-Pérez M, Hsia DS, Sloan L, Nell H, Mungur O, Hovsepian L, Schmider W, Spranger R, Yang N, Niemoeller E

Pediatric diabetes24 Apr 2022Cited by 15 (Europe PMC)

PMID35411611 (opens in a new tab)PMCIDPMC9790255 (opens in a new tab)DOI10.1111/pedi.13343 (opens in a new tab)PepBankPUB-35411611
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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. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In children and adolescents with type 2 diabetes, mean lixisenatide concentrations generally increased with dose irrespective of anti-drug antibody status.

    In plain wordsIn children and adolescents with diabetes, higher lixisenatide doses generally produced higher drug concentrations regardless of antibody status.

    Peptide
    Lixisenatide
    Outcome
    IncreasePlasma concentration by dose
    Study

    n = 18

    Comparator
    Lower lixisenatide doses
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    Mean lixisenatide concentrations generally increased with increasing doses irrespective of anti-drug antibody (ADA) status; however, mean lixisenatide concentrations and inter-subject variability were higher for participants with positive ADA status.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  2. 02HumanNon-randomized trialEfficacy outcome

    In children and adolescents with diabetes, improvements in fasting glucose, post-prandial glucose, glucose AUC, HbA1c and body weight were observed with lixisenatide.

    In plain wordsIn children and adolescents with diabetes, several glucose measures and body weight improved during lixisenatide treatment.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedGlucose, HbA1c and body weight outcomes
    Study

    n = 18

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    Improvements in fasting plasma glucose, post-prandial glucose, AUC0-4.5 , HbA1c , and body weight were observed with lixisenatide.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  3. 03HumanNon-randomized trialSafety outcome

    In children and adolescents with diabetes receiving lixisenatide, no unexpected side effects were reported.

    In plain wordsIn children and adolescents with diabetes receiving lixisenatide, researchers reported no unexpected side effects.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedUnexpected side effects
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    Overall, the safety profile was consistent with the known profile in adults, with no unexpected side effects and no treatment-emergent adverse events resulting in death or discontinuation.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  4. 04HumanNon-randomized trialSafety outcome

    In children and adolescents with diabetes receiving lixisenatide, no treatment-emergent adverse events resulted in death.

    In plain wordsIn children and adolescents with diabetes receiving lixisenatide, no treatment-emergent adverse events resulted in death.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedTreatment-emergent adverse events resulting in death
    Study

    n = 18

    Outcome group
    Mortality · Whole body
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    Overall, the safety profile was consistent with the known profile in adults, with no unexpected side effects and no treatment-emergent adverse events resulting in death or discontinuation.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  5. 05HumanNon-randomized trialSafety outcome

    In children and adolescents with diabetes receiving lixisenatide, no treatment-emergent adverse events resulted in discontinuation.

    In plain wordsIn children and adolescents with diabetes receiving lixisenatide, no treatment-emergent adverse events caused treatment discontinuation.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedTreatment-emergent adverse events resulting in discontinuation
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    Overall, the safety profile was consistent with the known profile in adults, with no unexpected side effects and no treatment-emergent adverse events resulting in death or discontinuation.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  6. 06HumanNon-randomized trialSafety outcome

    In children and adolescents with diabetes, vomiting occurred in 11.1% receiving lixisenatide.

    In plain wordsIn children and adolescents with diabetes, 11.1% receiving lixisenatide experienced vomiting.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedVomiting
    Study

    n = 18

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Measurements

    Vomiting incidence
    11.1%
    lixisenatide group

    Source sentences

    Summary
    The most common events in the lixisenatide group were vomiting (11.1%) and nausea (11.1%).
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  7. 07HumanNon-randomized trialSafety outcome

    In children and adolescents with diabetes, nausea occurred in 11.1% receiving lixisenatide.

    In plain wordsIn children and adolescents with diabetes, 11.1% receiving lixisenatide experienced nausea.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedNausea
    Study

    n = 18

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Measurements

    Nausea incidence
    11.1%
    lixisenatide group

    Source sentences

    Summary
    The most common events in the lixisenatide group were vomiting (11.1%) and nausea (11.1%).
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  8. 08HumanNon-randomized trialSafety outcome

    In children and adolescents with diabetes receiving lixisenatide, no symptomatic hypoglycemia was reported.

    In plain wordsIn children and adolescents with diabetes receiving lixisenatide, researchers reported no symptomatic hypoglycemia.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedSymptomatic hypoglycemia
    Study

    n = 18

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    No symptomatic hypoglycemia was reported in either group.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  9. 09HumanNon-randomized trialSafety outcome

    In children and adolescents with diabetes receiving lixisenatide, no clinically significant hematologic abnormalities were observed.

    In plain wordsIn children and adolescents with diabetes receiving lixisenatide, researchers observed no clinically significant blood-cell abnormalities.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedHematologic abnormalities
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    No clinically significant hematologic, biochemical or vital sign abnormalities were observed.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  10. 10HumanNon-randomized trialSafety outcome

    In children and adolescents with diabetes receiving lixisenatide, no clinically significant biochemical abnormalities were observed.

    In plain wordsIn children and adolescents with diabetes receiving lixisenatide, researchers observed no clinically significant biochemical abnormalities.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedBiochemical abnormalities
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    No clinically significant hematologic, biochemical or vital sign abnormalities were observed.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  11. 11HumanNon-randomized trialSafety outcome

    In children and adolescents with diabetes receiving lixisenatide, no clinically significant vital sign abnormalities were observed.

    In plain wordsIn children and adolescents with diabetes receiving lixisenatide, researchers observed no clinically significant vital sign abnormalities.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedVital sign abnormalities
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    No clinically significant hematologic, biochemical or vital sign abnormalities were observed.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  12. 12HumanObservational studyPharmacokinetics

    In children and adolescents with diabetes receiving lixisenatide, positive anti-drug antibody status was linked to higher mean drug concentrations.

    In plain wordsIn children and adolescents receiving lixisenatide, positive antibody status was linked to higher drug concentrations than non-positive status.

    Peptide
    Lixisenatide
    Outcome
    IncreasePlasma concentration by antibody status
    Study

    n: not reported in source

    Comparator
    Participants without positive ADA status
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    Mean lixisenatide concentrations generally increased with increasing doses irrespective of anti-drug antibody (ADA) status; however, mean lixisenatide concentrations and inter-subject variability were higher for participants with positive ADA status.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.
  13. 13HumanObservational studyPharmacokinetics

    In children and adolescents with diabetes receiving lixisenatide, positive anti-drug antibody status was linked to higher inter-subject concentration variability.

    In plain wordsIn children and adolescents receiving lixisenatide, positive antibody status was linked to greater variation in drug concentrations than non-positive status.

    Peptide
    Lixisenatide
    Outcome
    IncreaseInter-subject variability by antibody status
    Study

    n: not reported in source

    Comparator
    Participants without positive ADA status
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 10, and 20 μg once daily in 2-week increments · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    Mean lixisenatide concentrations generally increased with increasing doses irrespective of anti-drug antibody (ADA) status; however, mean lixisenatide concentrations and inter-subject variability were higher for participants with positive ADA status.
    1 context sentence
    Summary · context
    In this Phase 1, multicenter, randomized, double-blind, placebo-controlled, parallel-group, ascending repeated dose study (NCT02803918), participants aged ≥10 and < 18 years were randomized 3:1 to receive once-daily lixisenatide in 2-week increments of 5, 10, and 20 μg (n = 18) or placebo (n = 5) for 6 weeks.

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02803918

A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)

Sanofin = 2317 May 2017 to 27 Jan 2020

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 25 Apr 2022

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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