Pharmacodynamics of the glucagon-like peptide-1 receptor agonist lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus poorly controlled on sulphonylureas with/without metformin.

Seino Y, Takami A, Boka G, Niemoeller E, Raccah D

Diabetes, obesity & metabolism12 Mar 2014Cited by 23 (Europe PMC)

PMID24524806PMCIDPMC4312941DOI10.1111/dom.12276PepBankPUB-24524806

Read at source 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: CC BY-NC. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese and Caucasian patients with diabetes, once-daily lixisenatide reduced postprandial glucose AUC more than placebo (p < 0.0001).
In plain wordsIn Japanese and Caucasian patients with diabetes, once-daily lixisenatide reduced blood sugar after breakfast more than placebo.
Peptide
Lixisenatide
Outcome
DecreasePostprandial glucose AUC, once daily
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 to 30 µg once daily · 5 to 6 weeksAs given in this study (human).
Measurements
P
< 0.0001
all study populations
Source sentences
Summary
Change from baseline in PPG AUC[0:29-4:30 h] with lixisenatide QD and BID was significantly greater than placebo (p < 0.0001 for all study populations), with particularly prominent effects in Japanese patients.
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480601
02HumanRandomized controlled trialEfficacy outcome
In Japanese and Caucasian patients with diabetes, twice-daily lixisenatide reduced postprandial glucose AUC more than placebo (p < 0.0001).
In plain wordsIn Japanese and Caucasian patients with diabetes, twice-daily lixisenatide reduced blood sugar after breakfast more than placebo.
Peptide
Lixisenatide
Outcome
DecreasePostprandial glucose AUC, twice daily
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 to 30 µg twice daily · 5 to 6 weeksAs given in this study (human).
Measurements
P
< 0.0001
all study populations
Source sentences
Summary
Change from baseline in PPG AUC[0:29-4:30 h] with lixisenatide QD and BID was significantly greater than placebo (p < 0.0001 for all study populations), with particularly prominent effects in Japanese patients.
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480602
03HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, once-daily lixisenatide reduced postprandial glucose AUC more than twice-daily lixisenatide.
In plain wordsIn patients with diabetes, once-daily lixisenatide reduced blood sugar after breakfast more than twice-daily lixisenatide.
Peptide
Lixisenatide
Outcome
DecreasePostprandial glucose AUC, once versus twice daily
Study
n: not reported in source
Comparator
Twice-daily lixisenatide
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 to 30 µg once daily · 5 to 6 weeksAs given in this study (human).
Source sentences
Summary
Greater reductions in PPG AUC[0:29-4:30 h] were seen with lixisenatide QD versus BID, while the totality of evidence suggested that the lixisenatide 20 µg dose was optimal.
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480603
04HumanRandomized controlled trialEfficacy outcome
In the overall population of patients with diabetes, change from baseline in 2-h postprandial glucose with once-daily lixisenatide was significantly different from placebo (p < 0.01).
In plain wordsIn patients with diabetes, once-daily lixisenatide changed blood sugar two hours after a meal more than placebo did.
Peptide
Lixisenatide
Outcome
Direction not reportedTwo-hour postprandial glucose, once daily
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 to 30 µg once daily · 5 to 6 weeksAs given in this study (human).
Measurements
P
< 0.01
once daily versus placebo
Source sentences
Summary
In the overall population, changes from baseline for 2-h PPG, HbA1c and FPG were significant with lixisenatide QD and BID versus placebo (p < 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480604
05HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes in the overall population, the change from baseline in 2-hour postprandial glucose differed significantly between twice-daily lixisenatide and placebo (p < 0.01).
In plain wordsIn patients with diabetes, the change in blood sugar two hours after a meal differed significantly between twice-daily lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
Direction not reportedTwo-hour postprandial glucose, twice daily
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 to 30 µg twice daily · 5 to 6 weeksAs given in this study (human).
Measurements
P
< 0.01
twice daily versus placebo
Source sentences
Summary
In the overall population, changes from baseline for 2-h PPG, HbA1c and FPG were significant with lixisenatide QD and BID versus placebo (p < 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480605
06HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes in the overall population, the change from baseline in HbA1c differed significantly between once-daily lixisenatide and placebo (p < 0.01).
In plain wordsIn patients with diabetes, the change in HbA1c differed significantly between once-daily lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
Direction not reportedHbA1c, once daily
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 to 30 µg once daily · 5 to 6 weeksAs given in this study (human).
Measurements
P
< 0.01
once daily versus placebo
Source sentences
Summary
In the overall population, changes from baseline for 2-h PPG, HbA1c and FPG were significant with lixisenatide QD and BID versus placebo (p < 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480606
07HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes in the overall population, the change from baseline in HbA1c differed significantly between twice-daily lixisenatide and placebo (p < 0.01).
In plain wordsIn patients with diabetes, the change in HbA1c differed significantly between twice-daily lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
Direction not reportedHbA1c, twice daily
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 to 30 µg twice daily · 5 to 6 weeksAs given in this study (human).
Measurements
P
< 0.01
twice daily versus placebo
Source sentences
Summary
In the overall population, changes from baseline for 2-h PPG, HbA1c and FPG were significant with lixisenatide QD and BID versus placebo (p < 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480607
08HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes in the overall population, the change from baseline in fasting plasma glucose differed significantly between once-daily lixisenatide and placebo (p < 0.01).
In plain wordsIn patients with diabetes, the change in fasting blood sugar differed significantly between once-daily lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
Direction not reportedFasting plasma glucose, once daily
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 to 30 µg once daily · 5 to 6 weeksAs given in this study (human).
Measurements
P
< 0.01
once daily versus placebo
Source sentences
Summary
In the overall population, changes from baseline for 2-h PPG, HbA1c and FPG were significant with lixisenatide QD and BID versus placebo (p < 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480608
09HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes in the overall population, the change from baseline in fasting plasma glucose differed significantly between twice-daily lixisenatide and placebo (p < 0.01).
In plain wordsIn patients with diabetes, the change in fasting blood sugar differed significantly between twice-daily lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
Direction not reportedFasting plasma glucose, twice daily
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 to 30 µg twice daily · 5 to 6 weeksAs given in this study (human).
Measurements
P
< 0.01
twice daily versus placebo
Source sentences
Summary
In the overall population, changes from baseline for 2-h PPG, HbA1c and FPG were significant with lixisenatide QD and BID versus placebo (p < 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480609
10HumanNon-randomized trialSafety outcome
In Japanese and Caucasian patients with diabetes, lixisenatide was well tolerated.
In plain wordsIn Japanese and Caucasian patients with diabetes, lixisenatide was well tolerated.
Peptide
Lixisenatide
Outcome
Direction not reportedOverall tolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · 5 to 6 weeksAs given in this study (human).
Source sentences
Summary
Lixisenatide was well tolerated.
2 context sentences(design, population, supporting numbers)
Summary · context
The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.
Summary · context
This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID).
Report a problemFND-2452480610

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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

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

Pharmacodynamics of the glucagon-like peptide-1 receptor agonist lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus poorly controlled on sulphonylureas with/without metformin.

Summary

Results from this study10

Version history

Subjects

Publication types

MeSH terms

Keywords