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Study · Non-randomized trial · 2019

8 results

Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world.

Dailey G, Bajaj HS, Dex T, Groleau M, Stager W, Vinik A

BMJ open diabetes research & care21 Mar 2019Cited by 2 (Europe PMC)

PMID31114694 (opens in a new tab)PMCIDPMC6501856 (opens in a new tab)DOI10.1136/bmjdrc-2018-000581 (opens in a new tab)PepBankPUB-31114694
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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. 01HumanNon-randomized trialEfficacy outcome

    In North American LixiLan-O patients, iGlarLixi reduced HbA1c more than insulin glargine at Week 30 (difference -0.31, p≤0.003).

    In plain wordsIn North American LixiLan-O patients, iGlarLixi reduced HbA1c more than insulin glargine at Week 30.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c in North America, LixiLan-O
    Study

    n: not reported in source

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    HbA1c difference
    −0.31 not stated
    North America, iGlarLixi versus iGlar

    Source sentences

    Summary
    Significantly larger reductions (p≤0.003) in HbA1c from baseline to Week 30 were achieved with iGlarLixi, compared with iGlar or lixisenatide, in NA and RoW patients in LixiLan-O (iGlarLixi vs iGlar: -0.31 and -0.29, respectively; iGlarLixi vs lixisenatide: -0.84 and -0.69, respectively)
  2. 02HumanNon-randomized trialEfficacy outcome

    In rest-of-world LixiLan-O patients, iGlarLixi reduced HbA1c more than insulin glargine at Week 30 (difference -0.29, p≤0.003).

    In plain wordsIn rest-of-world LixiLan-O patients, iGlarLixi reduced HbA1c more than insulin glargine at Week 30.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c in rest of world, LixiLan-O
    Study

    n: not reported in source

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    HbA1c difference
    −0.29 not stated
    Rest of world, iGlarLixi versus iGlar

    Source sentences

    Summary
    Significantly larger reductions (p≤0.003) in HbA1c from baseline to Week 30 were achieved with iGlarLixi, compared with iGlar or lixisenatide, in NA and RoW patients in LixiLan-O (iGlarLixi vs iGlar: -0.31 and -0.29, respectively; iGlarLixi vs lixisenatide: -0.84 and -0.69, respectively)
  3. 03HumanNon-randomized trialEfficacy outcome

    In North American LixiLan-L patients, iGlarLixi reduced HbA1c more than insulin glargine at Week 30 (difference -0.5, p≤0.003).

    In plain wordsIn North American LixiLan-L patients, iGlarLixi reduced HbA1c more than insulin glargine at Week 30.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c in North America, LixiLan-L
    Study

    n: not reported in source

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    HbA1c difference
    −0.5 not stated
    North America, iGlarLixi versus iGlar

    Source sentences

    Summary
    and in LixiLan-L (iGlarLixi vs iGlar: -0.5 and -0.51, respectively).
    1 context sentence
    Summary · context
    Significantly larger reductions (p≤0.003) in HbA1c from baseline to Week 30
  4. 04HumanNon-randomized trialEfficacy outcome

    In rest-of-world LixiLan-L patients, iGlarLixi reduced HbA1c more than insulin glargine at Week 30 (difference -0.51, p≤0.003).

    In plain wordsIn rest-of-world LixiLan-L patients, iGlarLixi reduced HbA1c more than insulin glargine at Week 30.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c in rest of world, LixiLan-L
    Study

    n: not reported in source

    Comparator
    Insulin glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    HbA1c difference
    −0.51 not stated
    Rest of world, iGlarLixi versus iGlar

    Source sentences

    Summary
    and in LixiLan-L (iGlarLixi vs iGlar: -0.5 and -0.51, respectively).
    1 context sentence
    Summary · context
    Significantly larger reductions (p≤0.003) in HbA1c from baseline to Week 30
  5. 05HumanNon-randomized trialEfficacy outcome

    In North American patients with diabetes, iGlarLixi had a significant weight benefit versus insulin glargine (-1.58 kg, p<0.001).

    In plain wordsIn North American patients with diabetes, iGlarLixi had a significant weight benefit versus insulin glargine.

    Peptide
    Lixisenatide
    Outcome
    DecreaseBody weight in North America
    Study

    n: not reported in source

    Comparator
    Insulin glargine
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Weight change
    −1.58 kg
    North America, reported benefit versus iGlar

    Source sentences

    Summary
    iGlarLixi resulted in significant weight benefits versus iGlar (change from baseline -1.58 and -1.29 kg for NA and RoW patients, respectively; p<0.001).
  6. 06HumanNon-randomized trialEfficacy outcome

    In rest-of-world patients with diabetes, iGlarLixi had a significant weight benefit versus insulin glargine (-1.29 kg, p<0.001).

    In plain wordsIn rest-of-world patients with diabetes, iGlarLixi had a significant weight benefit versus insulin glargine.

    Peptide
    Lixisenatide
    Outcome
    DecreaseBody weight in rest of world
    Study

    n: not reported in source

    Comparator
    Insulin glargine
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Weight change
    −1.29 kg
    Rest of world, reported benefit versus iGlar

    Source sentences

    Summary
    iGlarLixi resulted in significant weight benefits versus iGlar (change from baseline -1.58 and -1.29 kg for NA and RoW patients, respectively; p<0.001).
  7. 07HumanNon-randomized trialSafety outcome

    In patients with diabetes, gastrointestinal adverse events were similar with iGlarLixi and insulin glargine.

    In plain wordsGastrointestinal adverse events were similar with iGlarLixi and insulin glargine in patients with diabetes.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedGastrointestinal adverse events with iGlarLixi
    Study

    n: not reported in source

    Comparator
    Insulin glargine
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    GI adverse events were similar for iGlarLixi and iGlar, but significantly higher for lixisenatide.
  8. 08HumanNon-randomized trialSafety outcome

    In patients with diabetes, gastrointestinal adverse events were significantly higher with lixisenatide alone, in contrast to similar rates with iGlarLixi and insulin glargine.

    In plain wordsGastrointestinal adverse events were significantly higher with lixisenatide alone, while iGlarLixi and insulin glargine had similar rates, in patients with diabetes.

    Peptide
    Lixisenatide
    Outcome
    IncreaseGastrointestinal adverse events with lixisenatide alone
    Study

    n: not reported in source

    Comparator
    iGlarLixi and insulin glargine
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    GI adverse events were similar for iGlarLixi and iGlar, but significantly higher for lixisenatide.

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 postedNCT02058147

Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

Sanofin = 1,170Feb 2014 to Jun 2015

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 9 May 2017
CompletedPhase 3Results postedNCT02058160

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

Sanofin = 736Jan 2014 to Jul 2015

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 9 May 2017

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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