Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia).

Seino Y, Min KW, Niemoeller E, Takami A

Diabetes, obesity & metabolism30 May 2012Cited by 222 (Europe PMC)

PMID22564709PMCIDPMC3466411DOI10.1111/j.1463-1326.2012.01618.xPepBankPUB-22564709

Summary

AimsTo assess the efficacy and safety of once-daily lixisenatide versus placebo in Asian patients with type 2 diabetes insufficiently controlled on basal insulin ± sulfonylurea.MethodsIn this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily. The primary endpoint was HbA(1c) change from baseline to week 24.ResultsOnce-daily lixisenatide significantly improved HbA(1c) versus placebo (LS mean difference vs. placebo = -0.88% [95%CI= -1.116, -0.650]; p < 0.0001), and allowed more patients to achieve HbA(1c) <7.0% (35.6 vs. 5.2%) and ≤ 6.5% (17.8 vs. 1.3%). Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose. Lixisenatide was well tolerated; 86% of patients on lixisenatide completed the study versus 92% on placebo. Ten (6.5%) lixisenatide and 9 (5.7%) placebo patients experienced serious adverse events. More lixisenatide patients [14 (9.1%)] discontinued for adverse events versus placebo [5 (3.2%)], mainly with gastrointestinal causes. Nausea and vomiting were reported in 39.6 and 18.2% of patients on lixisenatide versus 4.5 and 1.9% on placebo. Symptomatic hypoglycaemia was more frequent with lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas. No severe hypoglycaemia was reported.ConclusionsIn an Asian type 2 diabetes population insufficiently controlled by basal insulin ± sulfonylurea, once-daily lixisenatide significantly improved glycaemic control, with a pronounced postprandial effect, and was well tolerated.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study15

15 results from studies that gave the peptide. 15 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Asian patients with type 2 diabetes, lixisenatide reduced HbA1c versus placebo by 0.88% (95% CI -1.116 to -0.650, p < 0.0001).
In plain wordsIn Asian patients with diabetes, lixisenatide reduced HbA1c more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
LS mean HbA1c difference vs placebo
−0.88%
lixisenatide vs placebo, 24 weeks
95% CI of LS mean HbA1c difference
−1.116 to −0.65%
lower to upper bound
Source sentences
Summary
Once-daily lixisenatide significantly improved HbA(1c) versus placebo (LS mean difference vs. placebo = -0.88% [95%CI= -1.116, -0.650]; p < 0.0001), and allowed more patients to achieve HbA(1c) <7.0% (35.6 vs. 5.2%) and ≤ 6.5% (17.8 vs. 1.3%).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470901
02HumanRandomized controlled trialEfficacy outcome
In Asian patients with diabetes, 35.6% achieved HbA1c <7.0% with lixisenatide versus 5.2% with placebo.
In plain wordsMore patients reached HbA1c below 7.0% with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c below 7.0%
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
Patients achieving HbA1c <7.0%
35.6%
lixisenatide
Patients achieving HbA1c <7.0%
5.2%
placebo
Source sentences
Summary
Once-daily lixisenatide significantly improved HbA(1c) versus placebo (LS mean difference vs. placebo = -0.88% [95%CI= -1.116, -0.650]; p < 0.0001), and allowed more patients to achieve HbA(1c) <7.0% (35.6 vs. 5.2%) and ≤ 6.5% (17.8 vs. 1.3%).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470902
03HumanRandomized controlled trialEfficacy outcome
In Asian patients with diabetes, 17.8% achieved HbA1c ≤6.5% with lixisenatide versus 1.3% with placebo.
In plain wordsMore patients reached HbA1c at most 6.5% with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c at most 6.5%
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
Patients achieving HbA1c ≤6.5%
17.8%
lixisenatide
Patients achieving HbA1c ≤6.5%
1.3%
placebo
Source sentences
Summary
Once-daily lixisenatide significantly improved HbA(1c) versus placebo (LS mean difference vs. placebo = -0.88% [95%CI= -1.116, -0.650]; p < 0.0001), and allowed more patients to achieve HbA(1c) <7.0% (35.6 vs. 5.2%) and ≤ 6.5% (17.8 vs. 1.3%).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470903
04HumanRandomized controlled trialEfficacy outcome
In Asian patients with diabetes, lixisenatide significantly improved 2-h postprandial plasma glucose versus placebo.
In plain wordsLixisenatide improved glucose after meals compared with placebo in Asian patients with diabetes.
Peptide
Lixisenatide
Outcome
Direction not reportedPostprandial plasma glucose
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Source sentences
Summary
Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470904
05HumanRandomized controlled trialEfficacy outcome
In Asian patients with diabetes, lixisenatide significantly improved glucose excursion versus placebo.
In plain wordsLixisenatide improved glucose excursions compared with placebo in Asian patients with diabetes.
Peptide
Lixisenatide
Outcome
Direction not reportedGlucose excursion
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Source sentences
Summary
Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470905
06HumanRandomized controlled trialEfficacy outcome
In Asian patients with diabetes, lixisenatide significantly improved average 7-point self-monitored blood glucose versus placebo.
In plain wordsLixisenatide improved average self-measured glucose compared with placebo in Asian patients with diabetes.
Peptide
Lixisenatide
Outcome
Direction not reportedAverage seven-point blood glucose
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Source sentences
Summary
Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470906
07HumanRandomized controlled trialEfficacy outcome
In Asian patients with diabetes, lixisenatide significantly improved fasting plasma glucose versus placebo.
In plain wordsLixisenatide improved fasting glucose compared with placebo in Asian patients with diabetes.
Peptide
Lixisenatide
Outcome
Direction not reportedFasting plasma glucose
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Source sentences
Summary
Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470907
08HumanRandomized controlled trialOther
In Asian patients with diabetes, 86% of patients on lixisenatide completed the study versus 92% on placebo.
In plain wordsFewer patients completed the study with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
DecreaseStudy completion
Study
n: not reported in source
Comparator
Placebo
Outcome group
Treatment adherence and retention · Whole body
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
Study completion
86%
lixisenatide
Study completion
92%
placebo
Source sentences
Summary
Lixisenatide was well tolerated; 86% of patients on lixisenatide completed the study versus 92% on placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470908
09HumanRandomized controlled trialSafety outcome
In Asian patients with diabetes, serious adverse events occurred in 10 (6.5%) lixisenatide patients versus 9 (5.7%) placebo patients.
In plain wordsSerious adverse events occurred in 6.5% with lixisenatide versus 5.7% with placebo.
Peptide
Lixisenatide
Outcome
IncreaseSerious adverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
Serious adverse events
10 patients
lixisenatide
Serious adverse events incidence
6.5%
lixisenatide
Serious adverse events
9 patients
placebo
Serious adverse events incidence
5.7%
placebo
Source sentences
Summary
Ten (6.5%) lixisenatide and 9 (5.7%) placebo patients experienced serious adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470909
10HumanRandomized controlled trialSafety outcome
In Asian patients with diabetes, 14 (9.1%) discontinued lixisenatide for adverse events versus 5 (3.2%) with placebo, mainly for gastrointestinal causes.
In plain wordsMore patients stopped lixisenatide for adverse events than placebo, mainly for gastrointestinal problems.
Peptide
Lixisenatide
Outcome
IncreaseDiscontinuation for adverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
Discontinuation for adverse events
14 patients
lixisenatide
Discontinuation for adverse events incidence
9.1%
lixisenatide
Discontinuation for adverse events
5 patients
placebo
Discontinuation for adverse events incidence
3.2%
placebo
Source sentences
Summary
More lixisenatide patients [14 (9.1%)] discontinued for adverse events versus placebo [5 (3.2%)], mainly with gastrointestinal causes.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470910
11HumanRandomized controlled trialSafety outcome
In Asian patients with diabetes, nausea occurred in 39.6% with lixisenatide versus 4.5% with placebo.
In plain wordsNausea occurred more often with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseNausea
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
Nausea incidence
39.6%
lixisenatide
Nausea incidence
4.5%
placebo
Source sentences
Summary
Nausea and vomiting were reported in 39.6 and 18.2% of patients on lixisenatide versus 4.5 and 1.9% on placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470911
12HumanRandomized controlled trialSafety outcome
In Asian patients with diabetes, vomiting occurred in 18.2% with lixisenatide versus 1.9% with placebo.
In plain wordsVomiting occurred more often with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseVomiting
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
Vomiting incidence
18.2%
lixisenatide
Vomiting incidence
1.9%
placebo
Source sentences
Summary
Nausea and vomiting were reported in 39.6 and 18.2% of patients on lixisenatide versus 4.5 and 1.9% on placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470912
13HumanRandomized controlled trialSafety outcome
In Asian patients with diabetes, symptomatic hypoglycaemia occurred in 42.9% with lixisenatide versus 23.6% with placebo.
In plain wordsSymptomatic low blood glucose occurred more often with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseSymptomatic hypoglycaemia
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
Symptomatic hypoglycaemia incidence
42.9%
lixisenatide, all patients
Symptomatic hypoglycaemia incidence
23.6%
placebo, all patients
Source sentences
Summary
Symptomatic hypoglycaemia was more frequent with lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470913
14HumanNon-randomized trialSafety outcome
No severe hypoglycaemia was reported in Asian patients receiving lixisenatide.
In plain wordsNo severe low blood glucose was reported with lixisenatide.
Peptide
Lixisenatide
Outcome
Not applicableSevere hypoglycaemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycaemia was reported.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470915
15HumanObservational studySafety outcome
Among patients without sulfonylureas, symptomatic hypoglycaemia was similar with lixisenatide and placebo (32.6% versus 28.3%).
In plain wordsWithout sulfonylureas, low blood glucose rates were similar with lixisenatide and placebo.
Peptide
Lixisenatide
Outcome
IncreaseSymptomatic hypoglycaemia without sulfonylureas
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 µg once daily · 24 weeksAs given in this study (human).
Measurements
Symptomatic hypoglycaemia incidence
32.6%
lixisenatide, patients not receiving sulfonylureas
Symptomatic hypoglycaemia incidence
28.3%
placebo, patients not receiving sulfonylureas
Source sentences
Summary
Symptomatic hypoglycaemia was more frequent with lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily.
Show in the study text Report a problemFND-2256470914

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00866658

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea (GETGOAL-L-ASIA)

Sanofin = 311Mar 2009 to Jun 2010

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 11 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

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