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Study · Randomized controlled trial · 2014

8 results

Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day.

Ahrén B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R

Journal of diabetes and its complications5 Jun 2014Cited by 14 (Europe PMC)

PMID25012990 (opens in a new tab)DOI10.1016/j.jdiacomp.2014.05.012 (opens in a new tab)PepBankPUB-25012990
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: CC BY-NC. 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, fasting glucose changes were comparable with lixisenatide before the main meal versus before breakfast.

    In plain wordsIn patients with diabetes, fasting glucose changes were comparable with lixisenatide before the main meal versus breakfast.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedFasting plasma glucose
    Study

    n: not reported in source

    Comparator
    Lixisenatide before breakfast
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Mean changes in FPG, body weight and DTSQs score were comparable between groups.
    2 context sentences
    Summary · context
    A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted.
    Summary · context
    Patients were administered lixisenatide before breakfast or the main meal.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, weight changed by -2.60 kg with main-meal lixisenatide versus -2.80 kg before breakfast, with comparable changes.

    In plain wordsIn patients with diabetes, weight loss was numerically smaller with main-meal lixisenatide than breakfast dosing, with comparable changes.

    Peptide
    Lixisenatide
    Outcome
    IncreaseBody weight
    Study

    n: not reported in source

    Comparator
    Lixisenatide before breakfast
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    Mean body weight change
    −2.6 kg
    lixisenatide before main meal
    Mean body weight change
    −2.8 kg
    lixisenatide before breakfast

    Source sentences

    Summary
    The mean change in body weight (kg) was -2.60 (main meal) and -2.80 (breakfast group).
    3 context sentences
    Summary · context
    Mean changes in FPG, body weight and DTSQs score were comparable between groups.
    Summary · context
    A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted.
    Summary · context
    Patients were administered lixisenatide before breakfast or the main meal.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, treatment satisfaction changes were comparable with lixisenatide before the main meal versus before breakfast.

    In plain wordsIn patients with diabetes, satisfaction changes were comparable with lixisenatide before the main meal versus breakfast.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedTreatment satisfaction
    Study

    n: not reported in source

    Comparator
    Lixisenatide before breakfast
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Mean changes in FPG, body weight and DTSQs score were comparable between groups.
    2 context sentences
    Summary · context
    A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted.
    Summary · context
    Patients were administered lixisenatide before breakfast or the main meal.
  4. 04HumanRandomized controlled trialSafety outcome

    In patients with diabetes, adverse event rates were similar with lixisenatide before the main meal versus before breakfast.

    In plain wordsIn patients with diabetes, adverse event rates were similar with lixisenatide before the main meal versus breakfast.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedAdverse events
    Study

    n: not reported in source

    Comparator
    Lixisenatide before breakfast
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    AE rates were similar between groups, including gastrointestinal AEs.
    2 context sentences
    Summary · context
    A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted.
    Summary · context
    Patients were administered lixisenatide before breakfast or the main meal.
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with diabetes, gastrointestinal adverse event rates were similar with lixisenatide before the main meal versus before breakfast.

    In plain wordsIn patients with diabetes, digestive adverse event rates were similar with lixisenatide before the main meal versus breakfast.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedGastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    Lixisenatide before breakfast
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    AE rates were similar between groups, including gastrointestinal AEs.
    2 context sentences
    Summary · context
    A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted.
    Summary · context
    Patients were administered lixisenatide before breakfast or the main meal.
  6. 06HumanNon-randomized trialEfficacy outcome

    In patients with diabetes, HbA1c changed by -0.65% at week 24 with lixisenatide before the main meal.

    In plain wordsIn patients with diabetes, HbA1c fell from baseline with lixisenatide before the main meal.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c change with main-meal administration
    Study

    n: not reported in source

    Comparator
    Baseline
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    Mean HbA1c change from baseline
    −0.65%
    lixisenatide before main meal, week 24
    Mean HbA1c change from baseline
    −7.1 mmol/mol
    lixisenatide before main meal, week 24

    Source sentences

    Summary
    Mean change in HbA1c from baseline at week 24 was -0.65% (-7.1mmol/mol; main meal) and -0.74% (-8.1mmol/mol; breakfast).
    2 context sentences
    Summary · context
    A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted.
    Summary · context
    Patients were administered lixisenatide before breakfast or the main meal.
  7. 07HumanNon-randomized trialEfficacy outcome

    In patients with diabetes, HbA1c changed by -0.74% at week 24 with lixisenatide before breakfast.

    In plain wordsIn patients with diabetes, HbA1c fell from baseline with lixisenatide before breakfast.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c change with breakfast administration
    Study

    n: not reported in source

    Comparator
    Baseline
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    Mean HbA1c change from baseline
    −0.74%
    lixisenatide before breakfast, week 24
    Mean HbA1c change from baseline
    −8.1 mmol/mol
    lixisenatide before breakfast, week 24

    Source sentences

    Summary
    Mean change in HbA1c from baseline at week 24 was -0.65% (-7.1mmol/mol; main meal) and -0.74% (-8.1mmol/mol; breakfast).
    2 context sentences
    Summary · context
    A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted.
    Summary · context
    Patients were administered lixisenatide before breakfast or the main meal.
  8. 08HumanNon-randomized trialEfficacy outcome

    In patients with diabetes, lixisenatide produced the greatest glucose reductions after the dosing meal, with residual effects at the subsequent meal.

    In plain wordsIn patients with diabetes, glucose reductions were greatest after the lixisenatide dosing meal and persisted at the next meal.

    Peptide
    Lixisenatide
    Outcome
    DecreasePostprandial glucose profile
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    The 7-point SMPG profiles showed greatest reductions in postprandial glucose after the meal at which lixisenatide was administered, with a residual effect seen on the subsequent meal.
    2 context sentences
    Summary · context
    A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted.
    Summary · context
    Patients were administered lixisenatide before breakfast or the main meal.

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 postedNCT01517412

Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Sanofin = 451Feb 2012 to May 2013

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 14 Oct 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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