Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (<50 years) obese patients with type 2 diabetes mellitus.

Van Gaal L, Souhami E, Zhou T, Aronson R

Journal of clinical & translational endocrinology11 Apr 2014Cited by 19 (Europe PMC)

PMID29159080PMCIDPMC5685032DOI10.1016/j.jcte.2014.03.001PepBankPUB-29159080

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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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In obese patients aged <50 years with diabetes, HbA1c <7% plus ≥5% weight loss occurred in 12.0% versus 7.5% with lixisenatide versus sitagliptin (weighted difference 4.6%, p = 0.1696).
In plain wordsIn obese patients aged <50 years with diabetes, combined glucose and weight target attainment was numerically higher with lixisenatide than sitagliptin, without significance.
Peptide
Lixisenatide
Outcome
IncreaseCombined HbA1c and weight target
Study
n = 319
Comparator
Sitagliptin
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily · injection · 24 weeksAs given in this study (human).
Measurements
Patients achieving HbA1c =5% weight loss
12%
lixisenatide
Patients achieving HbA1c =5% weight loss
7.5%
sitagliptin
Weighted average of proportion difference
4.6%
lixisenatide versus sitagliptin
P
0.1696
lixisenatide versus sitagliptin
Source sentences
Summary
The proportion of patients that achieved the primary endpoint was 12.0% for lixisenatide versus 7.5% for sitagliptin; weighted average of proportion difference: 4.6%, p = 0.1696).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the proportion of patients with a glycated hemoglobin (HbA_1c) <7% and ≥5% weight loss at 24 weeks.
Summary · context
This was a 24-week, double-blind, randomized, parallel-group study.
Summary · context
Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161).
Report a problemFND-2915908001
02HumanRandomized controlled trialEfficacy outcome
In young obese patients with diabetes, HbA1c target attainment was 40.7% with lixisenatide versus 40.0% with sitagliptin.
In plain wordsIn young obese patients with diabetes, HbA1c target attainment was numerically higher with lixisenatide than sitagliptin.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c below 7%
Study
n = 319
Comparator
Sitagliptin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily · injection · 24 weeksAs given in this study (human).
Measurements
Patients achieving HbA1c <7%
40.7%
lixisenatide
Patients achieving HbA1c <7%
40%
sitagliptin
Source sentences
Summary
A total of 40.7% of patients achieved HbA_1c <7% with lixisenatide versus 40.0% with sitagliptin.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, double-blind, randomized, parallel-group study.
Summary · context
Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161).
Report a problemFND-2915908002
03HumanRandomized controlled trialEfficacy outcome
In young obese patients with diabetes, lixisenatide reduced weight more than sitagliptin (difference -1.3 kg, p = 0.0006).
In plain wordsIn young obese patients with diabetes, lixisenatide reduced weight more than sitagliptin.
Peptide
Lixisenatide
Outcome
DecreaseBody weight
Study
n = 319
Comparator
Sitagliptin
Outcome group
Body weight · Metabolic and weight
Studied dose
20 μg once daily · injection · 24 weeksAs given in this study (human).
Measurements
LS mean difference in body weight
−1.3 kg
lixisenatide versus sitagliptin
P
0.0006
body weight, lixisenatide versus sitagliptin
Source sentences
Summary
Lixisenatide produced greater reductions in body weight (LS mean difference: -1.3 kg, p = 0.0006) and postprandial plasma glucose after a standardized meal test (LS mean difference: -34.4 mg/dL [-1.9 mmol/L], p = 0.0001) versus sitagliptin.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, double-blind, randomized, parallel-group study.
Summary · context
Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161).
Report a problemFND-2915908003
04HumanRandomized controlled trialEfficacy outcome
In young obese patients with diabetes, lixisenatide reduced postprandial glucose more than sitagliptin (difference -34.4 mg/dL, p = 0.0001).
In plain wordsIn young obese patients with diabetes, lixisenatide reduced glucose after meals more than sitagliptin.
Peptide
Lixisenatide
Outcome
DecreasePostprandial glucose
Study
n = 319
Comparator
Sitagliptin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 μg once daily · injection · 24 weeksAs given in this study (human).
Measurements
LS mean difference in postprandial plasma glucose
−34.4 mg/dL
lixisenatide versus sitagliptin
LS mean difference in postprandial plasma glucose
−1.9 mmol/L
lixisenatide versus sitagliptin
P
0.0001
postprandial plasma glucose, lixisenatide versus sitagliptin
Source sentences
Summary
Lixisenatide produced greater reductions in body weight (LS mean difference: -1.3 kg, p = 0.0006) and postprandial plasma glucose after a standardized meal test (LS mean difference: -34.4 mg/dL [-1.9 mmol/L], p = 0.0001) versus sitagliptin.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, double-blind, randomized, parallel-group study.
Summary · context
Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161).
Report a problemFND-2915908004
05HumanRandomized controlled trialSafety outcome
In young obese patients with diabetes, adverse events occurred in 63.9% with lixisenatide versus 60.9% with sitagliptin, with similar incidence.
In plain wordsIn young obese patients with diabetes, adverse events were numerically higher with lixisenatide than sitagliptin, with similar incidence.
Peptide
Lixisenatide
Outcome
IncreaseTreatment-emergent adverse events
Study
n = 319
Comparator
Sitagliptin
Outcome group
Adverse events · Whole body
Studied dose
20 μg once daily · injection · 24 weeksAs given in this study (human).
Measurements
Treatment-emergent adverse events
63.9%
lixisenatide
Treatment-emergent adverse events
60.9%
sitagliptin
Source sentences
Summary
There was a similar incidence of treatment-emergent adverse events (63.9% vs. 60.9%) and serious treatment-emergent adverse events (1.9% vs. 1.9%), with low rates of symptomatic hypoglycemia (0.6% vs. 1.9%) for lixisenatide and sitagliptin, respectively, and no cases of severe hypoglycemia.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, double-blind, randomized, parallel-group study.
Summary · context
Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161).
Report a problemFND-2915908005
06HumanRandomized controlled trialSafety outcome
In young obese patients with diabetes, serious adverse events occurred in 1.9% with both lixisenatide and sitagliptin.
In plain wordsIn young obese patients with diabetes, serious adverse event rates were equal with lixisenatide and sitagliptin.
Peptide
Lixisenatide
Outcome
Direction not reportedSerious adverse events
Study
n = 319
Comparator
Sitagliptin
Outcome group
Adverse events · Whole body
Studied dose
20 μg once daily · injection · 24 weeksAs given in this study (human).
Measurements
Serious treatment-emergent adverse events
1.9%
lixisenatide
Serious treatment-emergent adverse events
1.9%
sitagliptin
Source sentences
Summary
There was a similar incidence of treatment-emergent adverse events (63.9% vs. 60.9%) and serious treatment-emergent adverse events (1.9% vs. 1.9%), with low rates of symptomatic hypoglycemia (0.6% vs. 1.9%) for lixisenatide and sitagliptin, respectively, and no cases of severe hypoglycemia.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, double-blind, randomized, parallel-group study.
Summary · context
Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161).
Report a problemFND-2915908006
07HumanRandomized controlled trialSafety outcome
In young obese patients with diabetes, symptomatic hypoglycemia occurred in 0.6% with lixisenatide versus 1.9% with sitagliptin.
In plain wordsIn young obese patients with diabetes, symptomatic low glucose was numerically less frequent with lixisenatide than sitagliptin.
Peptide
Lixisenatide
Outcome
DecreaseSymptomatic hypoglycemia
Study
n = 319
Comparator
Sitagliptin
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 μg once daily · injection · 24 weeksAs given in this study (human).
Measurements
Symptomatic hypoglycemia
0.6%
lixisenatide
Symptomatic hypoglycemia
1.9%
sitagliptin
Source sentences
Summary
There was a similar incidence of treatment-emergent adverse events (63.9% vs. 60.9%) and serious treatment-emergent adverse events (1.9% vs. 1.9%), with low rates of symptomatic hypoglycemia (0.6% vs. 1.9%) for lixisenatide and sitagliptin, respectively, and no cases of severe hypoglycemia.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, double-blind, randomized, parallel-group study.
Summary · context
Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161).
Report a problemFND-2915908007
08HumanNon-randomized trialSafety outcome
In young obese patients with diabetes, no severe hypoglycemia occurred with lixisenatide.
In plain wordsIn young obese patients with diabetes, no severe low glucose occurred with lixisenatide.
Peptide
Lixisenatide
Outcome
Not applicableSevere hypoglycemia
Study
n = 158
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 μg once daily · injection · 24 weeksAs given in this study (human).
Source sentences
Summary
There was a similar incidence of treatment-emergent adverse events (63.9% vs. 60.9%) and serious treatment-emergent adverse events (1.9% vs. 1.9%), with low rates of symptomatic hypoglycemia (0.6% vs. 1.9%) for lixisenatide and sitagliptin, respectively, and no cases of severe hypoglycemia.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, double-blind, randomized, parallel-group study.
Summary · context
Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161).
Report a problemFND-2915908008

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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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Keywords

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