Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono).

Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE

Diabetes care19 Mar 2012Cited by 167 (Europe PMC)

PMID22432104PMCIDPMC3357248DOI10.2337/dc11-1935PepBankPUB-22432104

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-ND. Results still quote short attributed sentences.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, two-step lixisenatide reduced HbA1c versus placebo by 0.54% (P < 0.0001).
In plain wordsIn patients with diabetes, lixisenatide with two-step titration lowered HbA1c more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseHbA1c, two-step titration
Study
n: not reported in source
Comparator
Combined placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Measurements
LS mean HbA1c change vs placebo
−0.54%
lixisenatide 2-step vs combined placebo
Source sentences
Summary
Once-daily lixisenatide significantly improved HbA(1c) (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: -0.54% for 2-step, -0.66% for 1-step; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210401
02HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, one-step lixisenatide reduced HbA1c versus placebo by 0.66% (P < 0.0001).
In plain wordsIn patients with diabetes, lixisenatide with one-step titration lowered HbA1c more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseHbA1c, one-step titration
Study
n: not reported in source
Comparator
Combined placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Measurements
LS mean HbA1c change vs placebo
−0.66%
lixisenatide 1-step vs combined placebo
Source sentences
Summary
Once-daily lixisenatide significantly improved HbA(1c) (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: -0.54% for 2-step, -0.66% for 1-step; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210402
03HumanRandomized controlled trialSafety outcome
In patients with diabetes, nausea occurred in 23% with lixisenatide overall versus 4.1% with placebo.
In plain wordsIn patients with diabetes, nausea was more frequent with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseNausea
Study
n = 361
Comparator
Combined placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Nausea incidence
23%
lixisenatide, overall
Nausea incidence
4.1%
combined placebo
Source sentences
Summary
The most common adverse events were gastrointestinal-nausea was the most frequent (lixisenatide 23% overall, placebo 4.1%).
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210411
04HumanRandomized controlled trialSafety outcome
In patients with diabetes, symptomatic hypoglycemia occurred in 1.7% with lixisenatide versus 1.6% with placebo.
In plain wordsIn patients with diabetes, symptomatic low glucose was numerically more frequent with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseSymptomatic hypoglycemia
Study
n = 361
Comparator
Combined placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Symptomatic hypoglycemia incidence
1.7%
lixisenatide
Symptomatic hypoglycemia incidence
1.6%
placebo
Source sentences
Summary
Symptomatic hypoglycemia occurred in 1.7% of lixisenatide and 1.6% of placebo patients, with no severe episodes.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210412
05HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, HbA1c <7.0% occurred in 52.2% with two-step lixisenatide versus 26.8% with placebo (P < 0.01).
In plain wordsIn patients with diabetes, more patients reached the HbA1c target with two-step lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c below 7.0%, two-step
Study
n: not reported in source
Comparator
Combined placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Patients achieving HbA1c <7.0%
52.2%
lixisenatide 2-step
Patients achieving HbA1c <7.0%
26.8%
combined placebo
Source sentences
Summary
Significantly more lixisenatide patients achieved HbA(1c) <7.0% (52.2% 2-step, 46.5% 1-step) and ≤ 6.5% (31.9% 2-step, 25.4% 1-step) versus placebo (26.8% and 12.5%, respectively; P < 0.01).
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210403
06HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, HbA1c <7.0% occurred in 46.5% with one-step lixisenatide versus 26.8% with placebo (P < 0.01).
In plain wordsIn patients with diabetes, more patients reached the HbA1c target with one-step lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c below 7.0%, one-step
Study
n: not reported in source
Comparator
Combined placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Patients achieving HbA1c <7.0%
46.5%
lixisenatide 1-step
Patients achieving HbA1c <7.0%
26.8%
combined placebo
Source sentences
Summary
Significantly more lixisenatide patients achieved HbA(1c) <7.0% (52.2% 2-step, 46.5% 1-step) and ≤ 6.5% (31.9% 2-step, 25.4% 1-step) versus placebo (26.8% and 12.5%, respectively; P < 0.01).
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210404
07HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, HbA1c ≤6.5% occurred in 31.9% with two-step lixisenatide versus 12.5% with placebo (P < 0.01).
In plain wordsIn patients with diabetes, more patients reached the lower HbA1c target with two-step lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c at most 6.5%, two-step
Study
n: not reported in source
Comparator
Combined placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Patients achieving HbA1c ≤6.5%
31.9%
lixisenatide 2-step
Patients achieving HbA1c ≤6.5%
12.5%
combined placebo
Source sentences
Summary
Significantly more lixisenatide patients achieved HbA(1c) <7.0% (52.2% 2-step, 46.5% 1-step) and ≤ 6.5% (31.9% 2-step, 25.4% 1-step) versus placebo (26.8% and 12.5%, respectively; P < 0.01).
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210405
08HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, HbA1c ≤6.5% occurred in 25.4% with one-step lixisenatide versus 12.5% with placebo (P < 0.01).
In plain wordsIn patients with diabetes, more patients reached the lower HbA1c target with one-step lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c at most 6.5%, one-step
Study
n: not reported in source
Comparator
Combined placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Patients achieving HbA1c ≤6.5%
25.4%
lixisenatide 1-step
Patients achieving HbA1c ≤6.5%
12.5%
combined placebo
Source sentences
Summary
Significantly more lixisenatide patients achieved HbA(1c) <7.0% (52.2% 2-step, 46.5% 1-step) and ≤ 6.5% (31.9% 2-step, 25.4% 1-step) versus placebo (26.8% and 12.5%, respectively; P < 0.01).
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210406
09HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, two-step lixisenatide significantly reduced fasting glucose versus placebo.
In plain wordsIn patients with diabetes, two-step lixisenatide lowered fasting glucose more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseFasting glucose, two-step
Study
n: not reported in source
Comparator
Combined placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
A significant decrease in fasting plasma glucose was observed in both lixisenatide groups versus placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210409
10HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, one-step lixisenatide significantly reduced fasting glucose versus placebo.
In plain wordsIn patients with diabetes, one-step lixisenatide lowered fasting glucose more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseFasting glucose, one-step
Study
n: not reported in source
Comparator
Combined placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
A significant decrease in fasting plasma glucose was observed in both lixisenatide groups versus placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210410
11HumanRandomized controlled trialSafety outcome
In patients with diabetes, safety and tolerability were similar with two-step versus one-step lixisenatide titration.
In plain wordsIn patients with diabetes, safety and tolerability were similar with two-step versus one-step lixisenatide titration.
Peptide
Lixisenatide
Outcome
Direction not reportedSafety and tolerability by titration regimen
Study
n: not reported in source
Comparator
One-step lixisenatide titration
Outcome group
Adverse events · Whole body
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Safety/tolerability was similar for the two dose regimens.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210414
12HumanNon-randomized trialSafety outcome
In patients with diabetes, no severe hypoglycemia episodes occurred with lixisenatide.
In plain wordsIn patients with diabetes, no severe low glucose episodes occurred with lixisenatide.
Peptide
Lixisenatide
Outcome
Not applicableSevere hypoglycemia
Study
n = 239
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Symptomatic hypoglycemia occurred in 1.7% of lixisenatide and 1.6% of placebo patients, with no severe episodes.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210413
13HumanNon-randomized trialEfficacy outcome
In patients with diabetes, lixisenatide significantly improved 2-h postprandial glucose during a standardized breakfast test.
In plain wordsIn patients with diabetes, lixisenatide improved glucose levels after breakfast.
Peptide
Lixisenatide
Outcome
Direction not reportedPostprandial glucose
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Lixisenatide led to marked significant improvements of 2-h postprandial glucose levels and blood glucose excursions measured during a standardized breakfast test.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210407
14HumanNon-randomized trialEfficacy outcome
In patients with diabetes, lixisenatide improved breakfast-test glucose excursions, with a 75% reduction reported in the conclusion.
In plain wordsIn patients with diabetes, lixisenatide improved the glucose rise during a breakfast test; a 75% reduction is reported, with no comparison named.
Peptide
Lixisenatide
Outcome
DecreasePostprandial glucose excursion
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily after titration · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Reduction in glucose excursion
75%
lixisenatide monotherapy; reference not stated in source
Source sentences
Summary
Lixisenatide led to marked significant improvements of 2-h postprandial glucose levels and blood glucose excursions measured during a standardized breakfast test.
2 context sentences(design, population, supporting numbers)
Summary · context
Once-daily lixisenatide monotherapy significantly improved glycemic control with a pronounced postprandial effect (75% reduction in glucose excursion) and was safe and well tolerated in type 2 diabetes.
Summary · context
Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy
Report a problemFND-2243210408

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

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

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

Status unknownPhase 1/2NCT02308254

Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People

Royal Adelaide Hospitaln = 30Nov 2013 to est. Apr 2016

Diabetes Mellitus · Gastroparesis

Trial page ClinicalTrials.govUpdated 29 Oct 2015

CompletedPhase 3Results postedNCT00688701

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy

Sanofin = 361May 2008 to Dec 2009

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 12 Dec 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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