Evaluation of the efficacy and safety of lixisenatide add-on treatment to basal insulin therapy among T2DM patients with different body mass indices from GetGoal trials.

Eto K, Naito Y, Seino Y

Diabetology & metabolic syndrome21 Nov 2015Cited by 9 (Europe PMC)

PMID26594250PMCIDPMC4654794DOI10.1186/s13098-015-0104-6PepBankPUB-26594250

Summary

BackgroundUsing patient data from the GetGoal-Duo1, -L, and L-Asia trials, the objectives of this study were to evaluate and compare the impact of lixisenatide once-daily add-on treatment to basal insulin therapy ±oral antidiabetic drugs (OADs) among type 2 diabetes (T2DM) patients subdivided into groups, based on their baseline body mass indices (BMI).MethodsData of patients treated with lixisenatide were extracted from the modified intent-to-treat populations of the trials. Patients were subdivided into 4 groups based on baseline BMI category (BMIs <25, 25-<30, 30-<35, and ≥35 kg/m(2)). At the unadjusted data level, efficacy and safety endpoints were evaluated and compared among study cohorts. Additionally, multivariable regression analyses were used to specify key patient characteristics and then assess the adjusted outcomes.ResultsOf the 662 T2DM patients, the mean changes in HbA1c (-0.63 to -0.73 %, p = 0.88) and FPG levels (-3.9 to 3.2 mg/dL, p = 0.60) were not significantly different among the different BMI groups. The proportions of T2DM patients that achieved HbA1c <7 % ranged between 34.7 and 46.8 %. After adjusted for patient characteristics, T2DM patients in the lowest BMI group relative to those in the highest BMI group had a smaller reduction in HbA1c during the trial periods (difference: 0.32 %, confidence interval: 0.10, 0.53, p = 0.005) and were less likely to achieve HbA1c <7 %.ConclusionsThe findings of this analysis of the GetGoal clinical trials suggest that lixisenatide may be a good treatment option for optimizing glycemic control in patients unable to achieve their HbA1c target on basal insulin therapy ±OADs, regardless of BMI category.

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

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanObservational studyEfficacy outcome
In lixisenatide-treated patients with diabetes, HbA1c changes ranged from -0.63 to -0.73%, without significant differences across BMI groups (p=0.88).
In plain wordsIn lixisenatide-treated patients with diabetes, HbA1c changes did not differ significantly across baseline BMI groups.
Peptide
Lixisenatide
Outcome
No significant changeUnadjusted HbA1c change across BMI groups
Study
n = 662
Comparator
Other baseline BMI groups
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Measurements
Mean HbA1c change
−0.73 to −0.63%
BMI groups
P
0.88
across BMI groups
Source sentences
Summary
Of the 662 T2DM patients, the mean changes in HbA1c (-0.63 to -0.73 %, p = 0.88) and FPG levels (-3.9 to 3.2 mg/dL, p = 0.60) were not significantly different among the different BMI groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Data of patients treated with lixisenatide were extracted from the modified intent-to-treat populations of the trials.
Summary · context
Patients were subdivided into 4 groups based on baseline BMI category (BMIs <25, 25-<30, 30-<35, and ≥35 kg/m(2)).
Show in the study text Report a problemFND-2659425001
02HumanObservational studyEfficacy outcome
In lixisenatide-treated patients with diabetes, fasting glucose changes ranged from -3.9 to 3.2 mg/dL, without significant BMI-group differences (p=0.60).
In plain wordsIn lixisenatide-treated patients with diabetes, fasting blood sugar changes did not differ significantly across baseline BMI groups.
Peptide
Lixisenatide
Outcome
No significant changeUnadjusted fasting plasma glucose change across BMI groups
Study
n = 662
Comparator
Other baseline BMI groups
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Measurements
Mean FPG change
−3.9 to 3.2 mg/dL
BMI groups
P
0.6
across BMI groups
Source sentences
Summary
Of the 662 T2DM patients, the mean changes in HbA1c (-0.63 to -0.73 %, p = 0.88) and FPG levels (-3.9 to 3.2 mg/dL, p = 0.60) were not significantly different among the different BMI groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Data of patients treated with lixisenatide were extracted from the modified intent-to-treat populations of the trials.
Summary · context
Patients were subdivided into 4 groups based on baseline BMI category (BMIs <25, 25-<30, 30-<35, and ≥35 kg/m(2)).
Show in the study text Report a problemFND-2659425002
03HumanObservational studyEfficacy outcome
In lixisenatide-treated patients with diabetes, the proportion reaching HbA1c <7% ranged from 34.7 to 46.8% across BMI groups.
In plain wordsIn lixisenatide-treated patients with diabetes, 34.7 to 46.8% reached HbA1c <7% across BMI groups.
Peptide
Lixisenatide
Outcome
Direction not reportedHbA1c below 7% across BMI groups
Study
n = 662
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Measurements
Responder proportion
34.7 to 46.8%
BMI groups
Source sentences
Summary
The proportions of T2DM patients that achieved HbA1c <7 % ranged between 34.7 and 46.8 %.
2 context sentences(design, population, supporting numbers)
Summary · context
Data of patients treated with lixisenatide were extracted from the modified intent-to-treat populations of the trials.
Summary · context
Patients were subdivided into 4 groups based on baseline BMI category (BMIs <25, 25-<30, 30-<35, and ≥35 kg/m(2)).
Show in the study text Report a problemFND-2659425003
04HumanObservational studyEfficacy outcome
In lixisenatide-treated patients with diabetes, lowest BMI was linked to a smaller HbA1c reduction than highest BMI, adjusted difference 0.32% (p=0.005).
In plain wordsIn lixisenatide-treated patients with diabetes, lowest BMI was linked to a smaller HbA1c reduction than highest BMI after adjustment.
Peptide
Lixisenatide
Outcome
IncreaseAdjusted HbA1c change in lowest versus highest BMI group
Study
n: not reported in source
Comparator
Highest baseline BMI group
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Measurements
Adjusted difference
0.32%
lowest versus highest BMI
Confidence interval lower
0.1%
adjusted difference
Confidence interval upper
0.53%
adjusted difference
P
0.005
adjusted difference
Source sentences
Summary
After adjusted for patient characteristics, T2DM patients in the lowest BMI group relative to those in the highest BMI group had a smaller reduction in HbA1c during the trial periods (difference: 0.32 %, confidence interval: 0.10, 0.53, p = 0.005) and were less likely to achieve HbA1c <7 %.
2 context sentences(design, population, supporting numbers)
Summary · context
Data of patients treated with lixisenatide were extracted from the modified intent-to-treat populations of the trials.
Summary · context
Patients were subdivided into 4 groups based on baseline BMI category (BMIs <25, 25-<30, 30-<35, and ≥35 kg/m(2)).
Show in the study text Report a problemFND-2659425004
05HumanObservational studyEfficacy outcome
In lixisenatide-treated patients with diabetes, lowest BMI was linked to lower likelihood of HbA1c <7% than highest BMI after adjustment.
In plain wordsIn lixisenatide-treated patients with diabetes, lowest BMI was linked to lower likelihood of HbA1c <7% than highest BMI after adjustment.
Peptide
Lixisenatide
Outcome
DecreaseAdjusted HbA1c target attainment in lowest versus highest BMI group
Study
n: not reported in source
Comparator
Highest baseline BMI group
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
After adjusted for patient characteristics, T2DM patients in the lowest BMI group relative to those in the highest BMI group had a smaller reduction in HbA1c during the trial periods (difference: 0.32 %, confidence interval: 0.10, 0.53, p = 0.005) and were less likely to achieve HbA1c <7 %.
2 context sentences(design, population, supporting numbers)
Summary · context
Data of patients treated with lixisenatide were extracted from the modified intent-to-treat populations of the trials.
Summary · context
Patients were subdivided into 4 groups based on baseline BMI category (BMIs <25, 25-<30, 30-<35, and ≥35 kg/m(2)).
Show in the study text Report a problemFND-2659425005

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

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