Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicentre study: The LixiLan JP-O2 randomized clinical trial.

Terauchi Y, Nakama T, Spranger R, Amano A, Inoue T, Niemoeller E

Diabetes, obesity & metabolism1 Sept 2020Cited by 36 (Europe PMC)

PMID32291880DOI10.1111/dom.14036PepBankPUB-32291880

Publisher page PubMedAsk about this study

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 study6

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

01HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, HbA1c reduction was greater with iGlarLixi (-1.40%, -15.3 mmol/mol) than glargine (-0.76%, -8.3 mmol/mol).
In plain wordsIn Japanese patients with type 2 diabetes, adding lixisenatide to glargine reduced HbA1c more than glargine.
Peptide
Lixisenatide
Outcome
DecreaseHbA1c change
Study
n = 521
Comparator
Insulin glargine
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
HbA1c change
−1.4%
iGlarLixi, week 26
HbA1c change
−15.3 mmol/mol
iGlarLixi, week 26
HbA1c change
−0.76%
iGlar, week 26
HbA1c change
−8.3 mmol/mol
iGlar, week 26
Source sentences
Summary
HbA1c reduction was significantly greater with iGlarLixi (-1.40% [-15.3 mmol/mol]) than with iGlar (-0.76% [-8.3 mmol/mol]).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, multicentre, open-label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL).
Report a problemFND-3229188001
02HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, HbA1c target attainment was 71.5% with iGlarLixi versus 38.5% with glargine (P < .0001).
In plain wordsIn Japanese patients 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 = 521
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Patients reaching HbA1c <7%
71.5%
iGlarLixi, week 26
Patients reaching HbA1c <7%
38.5%
iGlar, week 26
P
< 0.0001
between groups
Source sentences
Summary
Significantly more iGlarLixi patients reached HbA1c <7% at week 26 (71.5% vs 38.5%, P < .0001), with significantly lower weight gain (LS mean difference -1.06 kg, P < .0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, multicentre, open-label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL).
Report a problemFND-3229188002
03HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, weight gain was lower with iGlarLixi than glargine (LS mean difference -1.06 kg, P < .0001).
In plain wordsIn Japanese patients with type 2 diabetes, adding lixisenatide to glargine reduced weight gain versus glargine.
Peptide
Lixisenatide
Outcome
DecreaseWeight gain
Study
n = 521
Comparator
Insulin glargine
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
LS mean difference in weight gain
−1.06 kg
iGlarLixi minus iGlar
P
< 0.0001
between groups
Source sentences
Summary
Significantly more iGlarLixi patients reached HbA1c <7% at week 26 (71.5% vs 38.5%, P < .0001), with significantly lower weight gain (LS mean difference -1.06 kg, P < .0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, multicentre, open-label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL).
Report a problemFND-3229188003
04HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, documented symptomatic hypoglycemia occurred in 14.2% with iGlarLixi versus 12.3% with glargine.
In plain wordsIn Japanese patients with type 2 diabetes, symptomatic low blood sugar was recorded in 14.2% with iGlarLixi and 12.3% with glargine.
Peptide
Lixisenatide
Outcome
IncreaseDocumented symptomatic hypoglycemia
Study
n = 521
Comparator
Insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Documented symptomatic hypoglycemia
14.2%
iGlarLixi
Documented symptomatic hypoglycemia
12.3%
iGlar
Source sentences
Summary
Documented symptomatic hypoglycemia (plasma glucose ≤3.9 mmol/L [70 mg/dL]) was recorded in 14.2% of patients with iGlarLixi and 12.3% with iGlar.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, multicentre, open-label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL).
Report a problemFND-3229188004
05HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, no severe hypoglycemia was reported in either the iGlarLixi or glargine group.
In plain wordsIn Japanese patients with type 2 diabetes, no severe low blood sugar was reported with iGlarLixi or glargine.
Peptide
Lixisenatide
Outcome
Not applicableSevere hypoglycemia
Study
n = 521
Comparator
Insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycemia was reported in either group.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, multicentre, open-label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL).
Report a problemFND-3229188005
06HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, investigators found no major TEAE incidence difference between iGlarLixi and glargine, except expected gastrointestinal issues.
In plain wordsIn Japanese patients with type 2 diabetes, overall adverse event incidence showed no major difference between iGlarLixi and glargine, except digestive issues.
Peptide
Lixisenatide
Outcome
Direction not reportedTreatment-emergent adverse events
Study
n = 521
Comparator
Insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Source sentences
Summary
Other than the expected gastrointestinal issues associated with glucagon-like peptide 1 receptor agonists, we found no major difference in the incidence of TEAEs.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, multicentre, open-label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL).
Report a problemFND-3229188006

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 3NCT02752828

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

Sanofin = 52123 May 2016 to 12 Mar 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.

PepBank is a research reference. Talk to a doctor before you use any peptide.