Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials.

Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M

The Journal of clinical endocrinology and metabolism30 Mar 2011Cited by 116 (Europe PMC)

PMID21450987DOI10.1210/jc.2010-2822PepBankPUB-21450987

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, 49 of 587 (8.3%) had low-level antibodies to liraglutide 1.8 mg after 26 weeks.
In plain wordsIn people with type 2 diabetes, 8.3% developed low levels of antibodies to liraglutide 1.8 mg after 26 weeks.
Peptide
Liraglutide
Outcome
Not applicableLow-level anti-liraglutide antibodies at 26 weeks, 1.8 mg
Study
n = 587
Outcome group
Immune response · Immune and inflammation
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
After 26 wk, 32 of 369 (8.7%) and 49 of 587 (8.3%) patients had low-level antibodies to liraglutide 1.2 and 1.8 mg, respectively
1 context sentence(design, population, supporting numbers)
Summary · context
Antibody data were collected during six Liraglutide Effect and Action in Diabetes (LEAD) trials (26-104 wk duration).
Report a problemFND-2145098702
02HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, 32 of 369 (8.7%) had low-level antibodies to liraglutide 1.2 mg after 26 weeks.
In plain wordsIn people with type 2 diabetes, 8.7% developed low levels of antibodies to liraglutide 1.2 mg after 26 weeks.
Peptide
Liraglutide
Outcome
Not applicableLow-level anti-liraglutide antibodies at 26 weeks, 1.2 mg
Study
n = 369
Outcome group
Immune response · Immune and inflammation
Studied dose
1.2 mg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
After 26 wk, 32 of 369 (8.7%) and 49 of 587 (8.3%) patients had low-level antibodies to liraglutide 1.2 and 1.8 mg, respectively
1 context sentence(design, population, supporting numbers)
Summary · context
Antibody data were collected during six Liraglutide Effect and Action in Diabetes (LEAD) trials (26-104 wk duration).
Report a problemFND-2145098701
03HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, low-level antibodies to liraglutide had a mean of 3.3% B/T (range 1.6-10.7%B/T).
In plain wordsIn people with type 2 diabetes, antibodies to liraglutide were present at low levels.
Peptide
Liraglutide
Outcome
Not applicableMagnitude of anti-liraglutide antibody levels
Study
n: not reported in source
Outcome group
Immune response · Immune and inflammation
Studied dose
1.2 and 1.8 mg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
mean 3.3% antibody-bound radioactivity out of total radioactivity (%B/T), range 1.6-10.7%B/T
1 context sentence(design, population, supporting numbers)
Summary · context
Antibody data were collected during six Liraglutide Effect and Action in Diabetes (LEAD) trials (26-104 wk duration).
Report a problemFND-2145098703
04HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, low-level anti-liraglutide antibodies did not attenuate glycemic efficacy (HbA1c reductions 1.1-1.3% in antibody-positive versus 1.2% in antibody-negative patients).
In plain wordsIn people with type 2 diabetes, low-level antibodies to liraglutide did not weaken its blood sugar lowering effect.
Peptide
Liraglutide
Outcome
No significant changeHbA1c reduction by antibody status
Study
n: not reported in source
Comparator
Antibody-negative patients
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 and 1.8 mg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
which did not attenuate glycemic efficacy (HbA(1c) reductions 1.1-1.3% in antibody-positive vs. 1.2% in antibody-negative patients).
1 context sentence(design, population, supporting numbers)
Summary · context
Antibody data were collected during six Liraglutide Effect and Action in Diabetes (LEAD) trials (26-104 wk duration).
Report a problemFND-2145098704
05HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes switched from exenatide to liraglutide, anti-exenatide antibodies did not compromise a further glycemic response (additional 0.4% HbA1c reduction).
In plain wordsIn people with type 2 diabetes who switched from exenatide to liraglutide, antibodies to exenatide did not stop HbA1c falling further.
Peptide
Liraglutide
Outcome
DecreaseFurther HbA1c response after switching from exenatide to liraglutide
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · extension phaseAs given in this study (human).
Source sentences
Summary
After switching from exenatide to liraglutide, anti-exenatide antibodies did not compromise a further glycemic response to liraglutide (additional 0.4% HbA(1c) reduction).
1 context sentence(design, population, supporting numbers)
Summary · context
Antibody data were collected during six Liraglutide Effect and Action in Diabetes (LEAD) trials (26-104 wk duration).
Report a problemFND-2145098705
06HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, low-level antibodies to liraglutide occurred in 8.3% to 8.7% at 26 weeks, whereas 61% of the LEAD-6 extension patients had anti-exenatide antibodies at wk 26.
In plain wordsIn people with type 2 diabetes, antibodies to liraglutide were much less frequent than antibodies to exenatide.
Peptide
Liraglutide
Outcome
DecreaseAntibody-positive proportion compared with exenatide
Study
n: not reported in source
Comparator
Exenatide
Outcome group
Immune response · Immune and inflammation
Studied dose
1.2 and 1.8 mg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
After 26 wk, 32 of 369 (8.7%) and 49 of 587 (8.3%) patients had low-level antibodies to liraglutide 1.2 and 1.8 mg, respectively
2 context sentences(design, population, supporting numbers)
Summary · context
In LEAD-6, 113 of 185 extension patients (61%) had anti-exenatide antibodies at wk 26 (range 2.4-60.2%B/T).
Summary · context
Antibody data were collected during six Liraglutide Effect and Action in Diabetes (LEAD) trials (26-104 wk duration).
Report a problemFND-2145098706

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Registered trials8

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

8 trials · 7 completed · 1 stopped early · 5 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00614120