Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study).

Yamada Y, Senda M, Naito Y, Tamura M, Watanabe D, Shuto Y, Urita Y

Diabetes, obesity & metabolism27 Apr 2017Cited by 6 (Europe PMC)

PMID28345162PMCIDPMC5573929DOI10.1111/dom.12945PepBankPUB-28345162

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Summary

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Text rights: CC BY-NC. 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 on insulin glargine, lixisenatide reduced postbreakfast glucose exposure more than sitagliptin at day 29.
In plain wordsLixisenatide reduced blood sugar exposure after breakfast more than sitagliptin in Japanese patients receiving background insulin glargine.
Peptide
Lixisenatide
Outcome
DecreasePostprandial glucose exposure change at day 29
Study
n = 136
Comparator
Sitagliptin 50 mg once daily
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 µg initially, increased weekly by 5 µg to 20 µg once daily · subcutaneousAs given in this study (human).
Measurements
LS mean PPG AUC change
−347.3 h·mg/dL
lixisenatide
LS mean PPG AUC change
−19.3 h·mmol/L
lixisenatide
LS mean PPG AUC change
−113.3 h·mg/dL
sitagliptin
LS mean PPG AUC change
−6.3 h·mmol/L
sitagliptin
LS mean between-group difference
−234 h·mg/dL
lixisenatide minus sitagliptin
LS mean between-group difference
−13 h·mmol/L
lixisenatide minus sitagliptin
95% CI lower
−285.02 h·mg/dL
between-group difference
95% CI upper
−183 h·mg/dL
between-group difference
3 more measurements in the study.
Source sentences
Summary
Lixisenatide reduced PPG exposure to a statistically significantly greater extent than sitagliptin: least squares (LS) mean change from baseline in PPG AUC₀_:00-4:00h was -347.3 h·mg/dL (-19.3 h·mmol/L) in the lixisenatide group and -113.3 h·mg/dL (-6.3 h·mmol/L) in the sitagliptin group
4 context sentences(design, population, supporting numbers)
Summary · context
(LS mean between-group difference -234.0 h·mg/dL [-13.0 h·mmol/L], 95% confidence interval -285.02 to -183.00 h·mg/dL [-15.8 to -10.2 h·mmol/L]; P < .0001).
Summary · context
The primary endpoint was the change in postprandial glucose (PPG) exposure 4 hours after a standardized breakfast (PPG area under the plasma glucose concentration-time curve [AUC₀_:00-4:00h ]) from baseline to day 29.
Summary · context
To evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100.
Summary · context
This multicentre, open-label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once-daily oral sitagliptin 50 mg.
Report a problemFND-2834516201
02HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes on insulin glargine, lixisenatide reduced maximum postprandial glucose excursion more than sitagliptin.
In plain wordsLixisenatide reduced the largest after-meal blood sugar rise more than sitagliptin in Japanese patients receiving background insulin glargine.
Peptide
Lixisenatide
Outcome
DecreaseMaximum postprandial glucose excursion
Study
n = 136
Comparator
Sitagliptin 50 mg once daily
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 µg initially, increased weekly by 5 µg to 20 µg once daily · subcutaneousAs given in this study (human).
Measurements
LS mean maximum PPG excursion change
−122.4 mg/dL
lixisenatide
LS mean maximum PPG excursion change
−46.6 mg/dL
sitagliptin
Reported converted change
−6.8 h·mmol/L
lixisenatide, unit as printed
Reported converted change
−2.6 h·mmol/L
sitagliptin, unit as printed
P value
< 0.0001
comparison
Source sentences
Summary
Lixisenatide led to significantly greater LS mean reductions in maximum PPG excursion than sitagliptin (-122.4 vs -46.6 mg/dL [-6.8 vs -2.6 h·mmol/L]; P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100.
Summary · context
This multicentre, open-label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once-daily oral sitagliptin 50 mg.
Report a problemFND-2834516202
03HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes on insulin glargine, lixisenatide reduced C-peptide exposure, fasting glycoalbumin, and gastric emptying rate more than sitagliptin.
In plain wordsWith background insulin glargine, lixisenatide reduced C-peptide exposure, fasting glycoalbumin, and stomach emptying rate more than sitagliptin.
Peptide
Lixisenatide
Outcome
DecreaseC-peptide exposure, fasting glycoalbumin, and gastric emptying rate
Study
n = 136
Comparator
Sitagliptin 50 mg once daily
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 µg initially, increased weekly by 5 µg to 20 µg once daily · subcutaneousAs given in this study (human).
Source sentences
Summary
Change-from-baseline reductions in exposure to C-peptide, fasting glycoalbumin levels, and the gastric emptying rate were greater in the lixisenatide than in the sitagliptin group.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100.
Summary · context
This multicentre, open-label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once-daily oral sitagliptin 50 mg.
Report a problemFND-2834516203
04HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes on insulin glargine, treatment-emergent adverse events were more frequent with lixisenatide than sitagliptin.
In plain wordsSide effects during treatment were more frequent with lixisenatide than sitagliptin in Japanese patients receiving background insulin glargine.
Peptide
Lixisenatide
Outcome
IncreaseTreatment-emergent adverse events
Study
n = 136
Comparator
Sitagliptin 50 mg once daily
Outcome group
Adverse events · Whole body
Studied dose
10 µg initially, increased weekly by 5 µg to 20 µg once daily · subcutaneousAs given in this study (human).
Measurements
Treatment-emergent adverse-event incidence
60.9%
lixisenatide
Treatment-emergent adverse-event incidence
16.4%
sitagliptin
Source sentences
Summary
The incidence of treatment-emergent adverse events was higher with lixisenatide (60.9%) than with sitagliptin (16.4%), with no serious events or severe hypoglycaemia reported.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100.
Summary · context
This multicentre, open-label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once-daily oral sitagliptin 50 mg.
Report a problemFND-2834516204
05HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes on insulin glargine, no serious events were reported with lixisenatide or sitagliptin.
In plain wordsNo serious events were reported with lixisenatide or sitagliptin in Japanese patients receiving background insulin glargine.
Peptide
Lixisenatide
Outcome
No significant changeSerious adverse events
Study
n = 136
Comparator
Sitagliptin 50 mg once daily
Outcome group
Adverse events · Whole body
Studied dose
10 µg initially, increased weekly by 5 µg to 20 µg once daily · subcutaneousAs given in this study (human).
Source sentences
Summary
The incidence of treatment-emergent adverse events was higher with lixisenatide (60.9%) than with sitagliptin (16.4%), with no serious events or severe hypoglycaemia reported.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100.
Summary · context
This multicentre, open-label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once-daily oral sitagliptin 50 mg.
Report a problemFND-2834516205
06HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes on insulin glargine, no severe hypoglycaemia was reported with lixisenatide or sitagliptin.
In plain wordsNo severe low blood sugar was reported with lixisenatide or sitagliptin in Japanese patients receiving background insulin glargine.
Peptide
Lixisenatide
Outcome
No significant changeSevere hypoglycaemia
Study
n = 136
Comparator
Sitagliptin 50 mg once daily
Outcome group
Adverse events · Metabolic and weight
Studied dose
10 µg initially, increased weekly by 5 µg to 20 µg once daily · subcutaneousAs given in this study (human).
Source sentences
Summary
The incidence of treatment-emergent adverse events was higher with lixisenatide (60.9%) than with sitagliptin (16.4%), with no serious events or severe hypoglycaemia reported.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100.
Summary · context
This multicentre, open-label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once-daily oral sitagliptin 50 mg.
Report a problemFND-2834516206

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 4NCT02200991

Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

Sanofin = 136Aug 2014 to Nov 2015

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 5 Oct 2016

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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