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Study · Randomized controlled trial · n = 38 · 2018

7 results

Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study.

Otowa-Suematsu N, Sakaguchi K, Nakamura T, Hara K, Kishi M, Hashimoto N, Yokota K, Yoshino H, Kuroki Y, Nishiumi T, Sou A, Komada H and 4 more

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Okada Y, Hirota Y, Tamori Y, Ogawa W

Diabetes therapy : research, treatment and education of diabetes and related disorders11 Sept 2018Cited by 4 (Europe PMC)

PMID30206903 (opens in a new tab)PMCIDPMC6167300 (opens in a new tab)DOI10.1007/s13300-018-0505-2 (opens in a new tab)PepBankPUB-30206903
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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 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 on insulin glargine, HbA1c change did not differ between lixisenatide and vildagliptin.

    In plain wordsWith background insulin glargine, lixisenatide and vildagliptin produced similar long-term blood sugar changes in Japanese patients with type 2 diabetes.

    Peptide
    Lixisenatide
    Outcome
    No significant changeHbA1c change
    Study

    n = 38

    Comparator
    Vildagliptin on background insulin glargine
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 μg/day · 12 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −0.6%
    lixisenatide
    SD
    0.7%
    lixisenatide
    HbA1c change
    −0.6%
    vildagliptin
    SD
    1.2%
    vildagliptin
    P value
    0.92
    between groups

    Source sentences

    Summary
    The change in HbA1c level from baseline to 12 weeks did not differ significantly between the lixisenatide and vildagliptin groups (- 0.6 ± 0.7% and - 0.6 ± 1.2%, respectively, P = 0.920).
    1 context sentence
    Summary · context
    In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes on insulin glargine, HbA1c target attainment did not differ between lixisenatide and vildagliptin.

    In plain wordsWith background insulin glargine, similar proportions reached the blood sugar target with lixisenatide and vildagliptin.

    Peptide
    Lixisenatide
    Outcome
    No significant changeHbA1c below target proportion
    Study

    n = 38

    Comparator
    Vildagliptin on background insulin glargine
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 μg/day · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Neither the proportion of patients achieving an HbA1c level below 7.0% nor the postprandial increase in glucose concentration was different between two groups.
    1 context sentence
    Summary · context
    In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes on insulin glargine, postprandial glucose increases did not differ between lixisenatide and vildagliptin.

    In plain wordsAfter-meal blood sugar rises were similar with lixisenatide and vildagliptin on background insulin glargine.

    Peptide
    Lixisenatide
    Outcome
    No significant changePostprandial glucose increase
    Study

    n = 38

    Comparator
    Vildagliptin on background insulin glargine
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 μg/day · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Neither the proportion of patients achieving an HbA1c level below 7.0% nor the postprandial increase in glucose concentration was different between two groups.
    1 context sentence
    Summary · context
    In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with…
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes on insulin glargine, treatment satisfaction did not differ between lixisenatide and vildagliptin.

    In plain wordsTreatment satisfaction was similar with lixisenatide and vildagliptin in Japanese patients receiving background insulin glargine.

    Peptide
    Lixisenatide
    Outcome
    No significant changeTreatment satisfaction
    Study

    n = 38

    Comparator
    Vildagliptin on background insulin glargine
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    20 μg/day · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment satisfaction as assessed with the Diabetes Treatment Satisfaction Questionnaire did not differ significantly between the two groups.
    1 context sentence
    Summary · context
    In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with…
  5. 05HumanNon-randomized trialEfficacy outcome

    In Japanese patients with type 2 diabetes on insulin glargine, body weight decreased significantly within the lixisenatide group.

    In plain wordsBody weight decreased from baseline in Japanese patients receiving lixisenatide with background insulin glargine.

    Peptide
    Lixisenatide
    Outcome
    DecreaseBody weight
    Study

    n = 18

    Comparator
    Baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    20 μg/day · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Body weight and serum low density lipoprotein (LDL) cholesterol level decreased significantly in the lixisenatide and vildagliptin groups, respectively.
    1 context sentence
    Summary · context
    In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with…
  6. 06HumanNon-randomized trialSafety outcome

    In Japanese patients with type 2 diabetes on insulin glargine, lixisenatide was associated with mild gastrointestinal symptoms.

    In plain wordsPatients receiving lixisenatide with background insulin glargine experienced mild stomach or bowel symptoms.

    Peptide
    Lixisenatide
    Outcome
    Not applicableMild gastrointestinal symptoms
    Study

    n = 18

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    20 μg/day · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Both drugs were associated with mild gastrointestinal symptoms but not with severe hypoglycemia.
    1 context sentence
    Summary · context
    In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with…
  7. 07HumanNon-randomized trialSafety outcome

    In Japanese patients with type 2 diabetes on insulin glargine, lixisenatide was not associated with severe hypoglycemia.

    In plain wordsThe study reported no association with severe low blood sugar for lixisenatide on background insulin glargine.

    Peptide
    Lixisenatide
    Outcome
    Not applicableSevere hypoglycemia
    Study

    n = 18

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    20 μg/day · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Both drugs were associated with mild gastrointestinal symptoms but not with severe hypoglycemia.
    1 context sentence
    Summary · context
    In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with…

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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

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