Study · Randomized controlled trial · n = 154 · 2021

10 results

Anti-interleukin-21 antibody and liraglutide for the preservation of β-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial.

von Herrath M, Bain SC, Bode B, Clausen JO, Coppieters K, Gaysina L, Gumprecht J, Hansen TK, Mathieu C, Morales C, Mosenzon O, Segel S, Tsoukas G, Pieber TR

The lancet. Diabetes & endocrinology1 Mar 2021Cited by 153 (Europe PMC)

PMID33662334DOI10.1016/s2213-8587(21)00019-xPepBankPUB-33662334

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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

2 results from studies that gave the peptide. 2 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with recent-onset type 1 diabetes, liraglutide alone did not significantly change the fall in stimulated C-peptide at week 54 versus placebo.
In plain wordsIn adults with recent-onset type 1 diabetes, liraglutide alone did not keep insulin-making function better than placebo after 54 weeks.
Peptide
Liraglutide
Outcome
No significant changeMMTT-stimulated C-peptide change at week 54, liraglutide alone
Study
n = 154
Comparator
Placebo
Analysis
Primary
Outcome group
Islet protection · Endocrine and hormones
Studied dose
Dose not stated · 54 weeksAs given in this study (human).
Source sentences
Summary
Compared with placebo (ratio to baseline 0·61, 39% decrease), the decrease in MMTT-stimulated C-peptide concentration from baseline to week 54 was significantly smaller with combination treatment (0·90, 10% decrease; estimated treatment ratio 1·48, 95% CI 1·16-1·89; p=0·0017), but not with anti-IL-2…
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
Report a problemFND-3366233402
02HumanRandomized controlled trialSafety outcome
In adults with recent-onset type 1 diabetes, the rate of hypoglycaemic events was lower with liraglutide alone than with placebo during the treatment period.
In plain wordsIn adults with recent-onset type 1 diabetes, low blood sugar events were less frequent with liraglutide alone than with placebo during treatment.
Peptide
Liraglutide
Outcome
DecreaseHypoglycaemic event rate, liraglutide alone
Study
n = 154
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 54 weeksAs given in this study (human).
Source sentences
Summary
The rate of hypoglycaemic events did not differ significantly between active treatment groups and placebo, with an exception of a lower rate in the liraglutide group than in the placebo group during the treatment period.
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
Report a problemFND-3366233407

Studies that did not test the peptide alone8

In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Liraglutide.

03HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with recent-onset type 1 diabetes, the combination of anti-IL-21 and liraglutide gave a smaller fall in stimulated C-peptide at week 54 than placebo (estimated treatment ratio 1.48).
In plain wordsIn adults with recent-onset type 1 diabetes, an anti-IL-21 antibody plus liraglutide kept more insulin-making function than placebo after 54 weeks.
Peptide
Liraglutide
Outcome
IncreaseMMTT-stimulated C-peptide change at week 54, anti-IL-21 plus liraglutide
Study
n = 154
Comparator
Placebo
Analysis
Primary
Outcome group
Islet protection · Endocrine and hormones
Measurements
estimated treatment ratio
1.48 ratio
combination vs placebo, week 54
Source sentences
Summary
Compared with placebo (ratio to baseline 0·61, 39% decrease), the decrease in MMTT-stimulated C-peptide concentration from baseline to week 54 was significantly smaller with combination treatment (0·90, 10% decrease; estimated treatment ratio 1·48, 95% CI 1·16-1·89; p=0·0017), but not with anti-IL-2…
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3366233401
04HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with recent-onset type 1 diabetes, HbA1c fell by 0.50 percentage points with all active treatments pooled and 0.10 with placebo; the differences were not significant.
In plain wordsIn adults with recent-onset type 1 diabetes, HbA1c fell a little more with the active treatments than with placebo, but not by a significant amount.
Peptide
Liraglutide
Outcome
No significant changeHbA1c change at week 54, all active treatments pooled
Study
n = 308
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c change
−0.5 percentage points
all active treatments
HbA1c change
−0.1 percentage points
placebo
Source sentences
Summary
Despite greater insulin use in the placebo group, the decrease in HbA_1c (a key secondary outcome) at week 54 was greater with all active treatments (-0·50 percentage points) than with placebo (-0·10 percentage points), although the differences versus placebo were not significant.
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3366233403
05HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with recent-onset type 1 diabetes, the effects of the active treatments diminished after treatment cessation.
In plain wordsIn adults with recent-onset type 1 diabetes, the effects of the treatments faded after treatment stopped.
Peptide
Liraglutide
Outcome
DecreasePersistence of effects after treatment cessation
Study
n = 308
Comparator
Placebo
Outcome group
Islet protection · Endocrine and hormones
Source sentences
Summary
The effects diminished upon treatment cessation.
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3366233404
06HumanNot a test of Liraglutide aloneRandomized controlled trialMechanism
In adults with recent-onset type 1 diabetes, changes in immune cell subsets across groups were transient and mild (less than 10% change over time).
In plain wordsIn adults with recent-onset type 1 diabetes, immune cell changes across all groups were brief and small.
Peptide
Liraglutide
Outcome
No significant changeImmune cell subset changes
Study
n = 308
Comparator
Placebo
Outcome group
Immune response · Immune and inflammation
Source sentences
Summary
Changes in immune cell subsets across groups were transient and mild (<10% change over time).
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3366233405
07HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with recent-onset type 1 diabetes, the most frequently reported adverse events included gastrointestinal disorders.
In plain wordsIn adults with recent-onset type 1 diabetes, stomach and bowel problems were among the most common side effects across the treatment groups.
Peptide
Liraglutide
Outcome
Not applicableMost frequent adverse events
Study
n = 308
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Source sentences
Summary
The most frequently reported adverse events included gastrointestinal disorders, in keeping with the known side-effect profile of liraglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3366233406
08HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with recent-onset type 1 diabetes, no events of diabetic ketoacidosis were observed.
In plain wordsIn adults with recent-onset type 1 diabetes, no diabetic ketoacidosis occurred in the trial.
Peptide
Liraglutide
Outcome
No significant changeDiabetic ketoacidosis events
Study
n = 308
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
No events of diabetic ketoacidosis were observed.
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3366233409
09HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with recent-onset type 1 diabetes, the hypoglycaemic event rate did not differ significantly between the other active treatment groups and placebo.
In plain wordsIn adults with recent-onset type 1 diabetes, low blood sugar events were not significantly different in the other treatment groups than with placebo.
Peptide
Liraglutide
Outcome
No significant changeHypoglycaemic event rate, other active treatment groups
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
The rate of hypoglycaemic events did not differ significantly between active treatment groups and placebo, with an exception of a lower rate in the liraglutide group than in the placebo group during the treatment period.
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3366233408
10HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with recent-onset type 1 diabetes, one participant died while on liraglutide, with the death considered unlikely to be related to trial treatment.
In plain wordsIn adults with recent-onset type 1 diabetes, one participant on liraglutide died; the trial team judged the death unlikely to be related to treatment.
Peptide
Liraglutide
Outcome
Not applicableDeath in a liraglutide-containing group
Study
n: not reported in source
Outcome group
Mortality · Whole body
Source sentences
Summary
One participant died while on liraglutide (considered unlikely to be related to trial treatment) in connection with three reported adverse events (hypoglycaemic coma, pneumonia, and brain oedema).
2 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.
Summary · context
Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-3366233410

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 not yet recruiting · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase 2NCT07430332

GLP-1 RA for Stage 1 Type 1 Diabetes

Children's Hospital Medical Center, Cincinnatin = 15est. 1 Sept 2027 to est. 1 Jan 2030

Stage 1 Diabetes Mellitus, Type 1

Trial page ClinicalTrials.govUpdated 24 Feb 2026

CompletedPhase 2Results postedNCT02443155

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Novo Nordisk A/Sn = 30810 Nov 2015 to 27 Feb 2019

Diabetes · Diabetes Mellitus, Type 1

Trial page ClinicalTrials.govUpdated 9 Apr 2021

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
12 Oct 2026, 11:11 UTC
Study results updated
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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