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Study · Randomized controlled trial · n = 321 · 2020

7 results

Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial.

Watada H, Takami A, Spranger R, Amano A, Hashimoto Y, Niemoeller E

Diabetes care15 Apr 2020Cited by 32 (Europe PMC)

PMID32295808 (opens in a new tab)PMCIDPMC7245357 (opens in a new tab)DOI10.2337/dc19-2452 (opens in a new tab)PepBankPUB-32295808
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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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, HbA1c fell less with lixisenatide (-0.51%, -5.6 mmol/mol) than iGlarLixi (-1.58%, -17.3 mmol/mol).

    In plain wordsIn Japanese patients with type 2 diabetes, lixisenatide reduced HbA1c less than insulin glargine/lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    IncreaseHbA1c change at week 26
    Study

    n = 321

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

    Measurements

    HbA1c change
    −0.51%
    lixisenatide, week 26
    HbA1c change
    −5.6 mmol/mol
    lixisenatide, week 26
    HbA1c change
    −1.58%
    iGlarLixi, week 26
    HbA1c change
    −17.3 mmol/mol
    iGlarLixi, week 26
    LS mean difference
    −1.07%
    iGlarLixi minus lixisenatide
    LS mean difference
    −11.7 mmol/mol
    iGlarLixi minus lixisenatide
    P
    < 0.0001
    between groups

    Source sentences

    Summary
    Change in HbA1c from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference -1.07% [-11.7 mmol/mol], P < 0.0001).
    1 context sentence
    Summary · context
    In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, HbA1c below 7% (53 mmol/mol) occurred in 19.4% with lixisenatide versus 65.2% with iGlarLixi.

    In plain wordsIn Japanese patients with type 2 diabetes, fewer lixisenatide patients reached the HbA1c target than insulin glargine/lixisenatide patients.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c target attainment at week 26
    Study

    n = 321

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

    Measurements

    Patients reaching HbA1c <7%
    19.4%
    lixisenatide, week 26
    Patients reaching HbA1c <7%
    65.2%
    iGlarLixi, week 26
    P
    < 0.0001
    between groups

    Source sentences

    Summary
    At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA1c P P < 0.0001).
    1 context sentence
    Summary · context
    In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, fasting glucose fell less with lixisenatide than iGlarLixi (iGlarLixi-minus-lixisenatide difference -2.29 mmol/L, -41.23 mg/dL).

    In plain wordsIn Japanese patients with type 2 diabetes, lixisenatide reduced fasting glucose less than insulin glargine/lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    IncreaseFasting plasma glucose reduction at week 26
    Study

    n = 321

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

    Measurements

    LS mean difference in FPG reduction
    −2.29 mmol/L
    iGlarLixi minus lixisenatide
    LS mean difference in FPG reduction
    −41.23 mg/dL
    iGlarLixi minus lixisenatide
    P
    < 0.0001
    between groups

    Source sentences

    Summary
    At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA1c P P < 0.0001).
    1 context sentence
    Summary · context
    In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks.
  4. 04HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, symptomatic hypoglycemia occurred in 2.5% with lixisenatide versus 13.0% with iGlarLixi through week 26.

    In plain wordsIn Japanese patients with type 2 diabetes, symptomatic low blood sugar occurred less often with lixisenatide than insulin glargine/lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    DecreaseDocumented symptomatic hypoglycemia through week 26
    Study

    n = 321

    Comparator
    Insulin glargine/lixisenatide
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Documented symptomatic hypoglycemia
    2.5%
    lixisenatide, through week 26
    Documented symptomatic hypoglycemia
    13%
    iGlarLixi, through week 26

    Source sentences

    Summary
    Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group.
    1 context sentence
    Summary · context
    In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks.
  5. 05HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, no severe hypoglycemic events occurred with lixisenatide or iGlarLixi through week 26.

    In plain wordsIn Japanese patients with type 2 diabetes, neither treatment group reported severe low blood sugar through week 26.

    Peptide
    Lixisenatide
    Outcome
    Not applicableSevere hypoglycemia through week 26
    Study

    n = 321

    Comparator
    Insulin glargine/lixisenatide
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group.
    1 context sentence
    Summary · context
    In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, gastrointestinal events occurred in 50.0% with lixisenatide versus 36.0% with iGlarLixi through week 52.

    In plain wordsIn Japanese patients with type 2 diabetes, digestive events occurred more often with lixisenatide than insulin glargine/lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    IncreaseGastrointestinal events through week 52
    Study

    n = 321

    Comparator
    Insulin glargine/lixisenatide
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Gastrointestinal events
    50%
    lixisenatide, through week 52
    Gastrointestinal events
    36%
    iGlarLixi, through week 52

    Source sentences

    Summary
    Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.
    1 context sentence
    Summary · context
    In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks.
  7. 07HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, treatment-emergent adverse event rates were similar with lixisenatide and iGlarLixi.

    In plain wordsIn Japanese patients with type 2 diabetes, adverse event rates were similar with lixisenatide and insulin glargine/lixisenatide.

    Peptide
    Lixisenatide
    Outcome
    Direction not reportedTreatment-emergent adverse events
    Study

    n = 321

    Comparator
    Insulin glargine/lixisenatide
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.
    1 context sentence
    Summary · context
    In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 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 3NCT02749890

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

Sanofin = 3219 May 2016 to May 2018

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 16 Jun 2020

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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