Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L randomized clinical trial.

Kaneto H, Takami A, Spranger R, Amano A, Watanabe D, Niemoeller E

Diabetes, obesity & metabolism1 Sept 2020Cited by 32 (Europe PMC)

PMID32072742DOI10.1111/dom.14005PepBankPUB-32072742

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, adding lixisenatide to insulin glargine reduced HbA1c more than glargine alone with metformin.
In plain wordsIn Japanese adults with type 2 diabetes, adding lixisenatide to glargine reduced HbA1c more than glargine alone with metformin.
Peptide
Lixisenatide
Outcome
DecreaseHbA1c change at week 26
Study
n = 512
Comparator
Insulin glargine with metformin
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
HbA1c change
−1.27%
iGlarLixi
HbA1c change
−0.53%
iGlar
LS mean difference
−0.74%
between groups
P
< 0.0001
between groups
Source sentences
Summary
iGlarLixi (n = 255) demonstrated significantly greater reductions in HbA1c (-1.27%) than iGlar (n = 257, -0.53%) (LS mean difference: -0.74%, P < .0001) at week 26, confirming the superiority of iGlarLixi.
1 context sentence(design, population, supporting numbers)
Summary · context
This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs.
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02HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, HbA1c target attainment was greater with iGlarLixi than glargine (51.8% versus 16.0%).
In plain wordsIn Japanese adults with type 2 diabetes, adding lixisenatide to glargine increased HbA1c target attainment versus glargine.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c below 7% at week 26
Study
n = 512
Comparator
Insulin glargine with metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Target attainment
51.8%
iGlarLixi
Target attainment
16%
iGlar
Source sentences
Summary
Significantly, more iGlarLixi patients reached target HbA1c <7% at week 26 (51.8% vs 16.0% for iGlar).
1 context sentence(design, population, supporting numbers)
Summary · context
This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs.
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03HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, weight changed by -0.51 kg with iGlarLixi versus +0.55 kg with glargine.
In plain wordsIn Japanese adults with type 2 diabetes, adding lixisenatide to glargine reduced weight compared with glargine.
Peptide
Lixisenatide
Outcome
DecreaseBody weight change
Study
n = 512
Comparator
Insulin glargine with metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Weight change
−0.51 kg
iGlarLixi
Weight change
0.55 kg
iGlar
Source sentences
Summary
iGlarLixi patients lost weight in contrast to iGlar patients (-0.51 kg vs +0.55 kg).
1 context sentence(design, population, supporting numbers)
Summary · context
This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs.
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04HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, documented symptomatic hypoglycemia occurred in 18.8% with iGlarLixi versus 16.7% with glargine.
In plain wordsIn Japanese adults with type 2 diabetes, symptomatic low blood sugar occurred more often with iGlarLixi than glargine.
Peptide
Lixisenatide
Outcome
IncreaseDocumented symptomatic hypoglycemia
Study
n = 512
Comparator
Insulin glargine with metformin
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Documented symptomatic hypoglycemia
18.8%
iGlarLixi
Documented symptomatic hypoglycemia
16.7%
iGlar
Source sentences
Summary
Documented symptomatic hypoglycemia (plasma glucose ≤ 3.9 mmol/L) was observed in 18.8% of iGlarLixi patients vs 16.7% of iGlar patients.
1 context sentence(design, population, supporting numbers)
Summary · context
This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs.
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05HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, gastrointestinal adverse events occurred in 33.3% with iGlarLixi versus 8.6% with glargine.
In plain wordsIn Japanese adults with type 2 diabetes, digestive adverse events occurred more often with iGlarLixi than glargine.
Peptide
Lixisenatide
Outcome
IncreaseGastrointestinal adverse events
Study
n = 512
Comparator
Insulin glargine with metformin
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Gastrointestinal-related adverse events
33.3%
iGlarLixi
Gastrointestinal-related adverse events
8.6%
iGlar
Source sentences
Summary
iGlarLixi patients had more gastrointestinal-related adverse events than iGlar patients (33.3% vs 8.6%), primarily nausea (16.9% vs 0.8%).
1 context sentence(design, population, supporting numbers)
Summary · context
This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs.
Report a problemFND-3207274205
06HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, nausea occurred in 16.9% with iGlarLixi versus 0.8% with glargine.
In plain wordsIn Japanese adults with type 2 diabetes, nausea occurred more often with iGlarLixi than glargine.
Peptide
Lixisenatide
Outcome
IncreaseNausea
Study
n = 512
Comparator
Insulin glargine with metformin
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Nausea
16.9%
iGlarLixi
Nausea
0.8%
iGlar
Source sentences
Summary
iGlarLixi patients had more gastrointestinal-related adverse events than iGlar patients (33.3% vs 8.6%), primarily nausea (16.9% vs 0.8%).
1 context sentence(design, population, supporting numbers)
Summary · context
This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs.
Report a problemFND-3207274206

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 3NCT02752412

Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

Sanofin = 51317 May 2016 to 4 Oct 2018

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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