Efficacy and safety of liraglutide for overweight adult patients with type 1 diabetes and insufficient glycaemic control (Lira-1): a randomised, double-blind, placebo-controlled trial.

Dejgaard TF, Frandsen CS, Hansen TS, Almdal T, Urhammer S, Pedersen-Bjergaard U, Jensen T, Jensen AK, Holst JJ, Tarnow L, Knop FK, Madsbad S, Andersen HU

The lancet. Diabetes & endocrinology3 Dec 2015Cited by 142 (Europe PMC)

PMID26656289DOI10.1016/s2213-8587(15)00436-2PepBankPUB-26656289

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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 study18

18 results from studies that gave the peptide. 18 results from people.

01HumanRandomized controlled trialEfficacy outcome
In overweight adults with type 1 diabetes, the change in HbA1c from baseline to week 24 did not differ between liraglutide and placebo given with insulin.
In plain wordsIn overweight adults with type 1 diabetes, adding liraglutide to insulin did not lower HbA1c more than adding placebo.
Peptide
Liraglutide
Outcome
No significant changeHbA1c change from baseline to week 24
Study
n = 100
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
At the end of treatment, change in HbA1c from baseline did not differ between groups (-0·5%, 95% CI -0·8 to -0·4 [-6·0 mmol/mol, 95% CI -8·7 to -4·4] with liraglutide vs -0·3%, -0·6 to -0·2 [-4·0 mmol/mol, -6·6 to -2·3] with placebo; between-group difference -0·2% [-0·5 to 0·1; 2·2 mmol/mol, -5·5 to 1·1], p=0·1833).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was change in HbA1c from baseline to week 24.
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
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02HumanRandomized controlled trialEfficacy outcome
In overweight adults with type 1 diabetes, the number of hypoglycaemic events was reduced with liraglutide, with an incident rate ratio of 0·82.
In plain wordsIn overweight adults with type 1 diabetes, liraglutide with insulin led to fewer low blood sugar events than placebo with insulin.
Peptide
Liraglutide
Outcome
DecreaseNumber of hypoglycaemic events
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
The number of hypoglycaemic events was reduced with liraglutide, with an incident rate ratio of 0·82 (95% CI 0·74 to 0·90).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
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03HumanRandomized controlled trialEfficacy outcome
In overweight adults with type 1 diabetes, glycaemic variability did not change with liraglutide compared with placebo.
In plain wordsIn overweight adults with type 1 diabetes, liraglutide did not change swings in blood sugar compared with placebo.
Peptide
Liraglutide
Outcome
No significant changeGlycaemic variability
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
However, we detected no changes in glycaemic variability (continuous overall net glycaemic action per 60 min from 10·3 [95% CI 9·8 to 10·8] to 9·9 [9·2 to 10·6] in the liraglutide treated patients vs 10·2 [9·7 to 10·7] to 9·7 [9·1 to 10·3] in the placebo treated patients).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
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04HumanRandomized controlled trialEfficacy outcome
In overweight adults with type 1 diabetes, bolus insulin dose decreased with liraglutide compared with placebo (difference -5·8 IU).
In plain wordsIn overweight adults with type 1 diabetes, liraglutide with insulin needed a lower mealtime insulin dose than placebo with insulin.
Peptide
Liraglutide
Outcome
DecreaseBolus insulin dose
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Difference in bolus insulin
−5.8 IU
liraglutide vs placebo
Source sentences
Summary
Both bolus insulin (difference -5·8 IU, 95% CI -10·7 to -0·8, p=0·0227) and bodyweight (difference -6·8 kg, 95% CI -12·2 to -1·4, p=0·0145) decreased with liraglutide treatment compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
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05HumanRandomized controlled trialEfficacy outcome
In overweight adults with type 1 diabetes, bodyweight decreased with liraglutide compared with placebo (difference -6·8 kg).
In plain wordsIn overweight adults with type 1 diabetes, liraglutide with insulin led to more weight loss than placebo with insulin.
Peptide
Liraglutide
Outcome
DecreaseBodyweight
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Difference in bodyweight
−6.8 kg
liraglutide vs placebo
Source sentences
Summary
Both bolus insulin (difference -5·8 IU, 95% CI -10·7 to -0·8, p=0·0227) and bodyweight (difference -6·8 kg, 95% CI -12·2 to -1·4, p=0·0145) decreased with liraglutide treatment compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628905
06HumanRandomized controlled trialSafety outcome
In overweight adults with type 1 diabetes, heart rate increased with liraglutide compared with placebo (difference 7·5 bpm).
In plain wordsIn overweight adults with type 1 diabetes, liraglutide raised heart rate more than placebo.
Peptide
Liraglutide
Outcome
IncreaseHeart rate
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Heart function · Cardiovascular
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Difference in heart rate
7.5 bpm
liraglutide vs placebo
Source sentences
Summary
Heart rate increased with liraglutide, with a difference between groups of 7·5 bpm (95% CI 2·8-12·2, p=0·0019).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
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07HumanRandomized controlled trialMechanism
In overweight adults with type 1 diabetes, postprandial plasma glucagon concentrations did not differ between liraglutide and placebo.
In plain wordsIn overweight adults with type 1 diabetes, liraglutide did not change blood glucagon after meals compared with placebo.
Peptide
Liraglutide
Outcome
No significant changePostprandial plasma glucagon
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Postprandial plasma glucagon and GLP-1 concentrations did not differ between groups (difference between groups at end of treatment: -408 mmol/L per 240 min [95% CI -941 to 125, p=0·1309] for glucagon and -266 mmol/L per 240 min [-1034 to 501, p=0·4899] for GLP-1).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628907
08HumanRandomized controlled trialMechanism
In overweight adults with type 1 diabetes, postprandial plasma GLP-1 concentrations did not differ between liraglutide and placebo.
In plain wordsIn overweight adults with type 1 diabetes, liraglutide did not change blood GLP-1 after meals compared with placebo.
Peptide
Liraglutide
Outcome
No significant changePostprandial plasma GLP-1
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Postprandial plasma glucagon and GLP-1 concentrations did not differ between groups (difference between groups at end of treatment: -408 mmol/L per 240 min [95% CI -941 to 125, p=0·1309] for glucagon and -266 mmol/L per 240 min [-1034 to 501, p=0·4899] for GLP-1).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
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09HumanRandomized controlled trialMechanism
In overweight adults with type 1 diabetes, gastric emptying was delayed after 3 weeks of liraglutide compared with placebo.
In plain wordsIn overweight adults with type 1 diabetes, the stomach emptied more slowly after 3 weeks of liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseGastric emptying after 3 weeks
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal motility · Gastrointestinal
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 3 weeksAs given in this study (human).
Measurements
Delay in gastric emptying
19.9 min
3 weeks
Source sentences
Summary
Gastric emptying was delayed after 3 weeks of treatment with liraglutide (19·9 min, 95% CI 0·8 to 39·0, p=0·0412)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628909
10HumanRandomized controlled trialMechanism
In overweight adults with type 1 diabetes, gastric emptying did not differ between liraglutide and placebo after 24 weeks.
In plain wordsIn overweight adults with type 1 diabetes, stomach emptying was no different from placebo after 24 weeks of liraglutide.
Peptide
Liraglutide
Outcome
No significant changeGastric emptying after 24 weeks
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal motility · Gastrointestinal
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Difference in gastric emptying
−1.5 min
24 weeks
Source sentences
Summary
but we detected no difference after 24 weeks of treatment (-1·5 min, -20·5 to 17·6, p=0·8793).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628910
11HumanRandomized controlled trialEfficacy outcome
In overweight adults with type 1 diabetes, perceived frequency of hypoglycaemia was higher with placebo than with liraglutide.
In plain wordsIn overweight adults with type 1 diabetes, patients on liraglutide felt they had fewer low blood sugar events than patients on placebo.
Peptide
Liraglutide
Outcome
DecreasePerceived frequency of hypoglycaemia
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Patient-reported outcome measures differed between groups only with respect to perceived frequency of hypoglycaemia, which was higher with placebo, with a difference between groups of -0·6 (95% CI -1·1 to -0·07, p=0·0257).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
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12HumanRandomized controlled trialEfficacy outcome
In overweight adults with type 1 diabetes, patient-reported outcome measures other than perceived hypoglycaemia frequency did not differ between liraglutide and placebo.
In plain wordsIn overweight adults with type 1 diabetes, apart from perceived low blood sugar, patient-reported outcomes were no different with liraglutide than placebo.
Peptide
Liraglutide
Outcome
No significant changeOther patient-reported outcome measures
Study
n = 100
Comparator
Placebo
Analysis
Secondary
Outcome group
Patient-reported outcomes · Whole body
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Patient-reported outcome measures differed between groups only with respect to perceived frequency of hypoglycaemia, which was higher with placebo, with a difference between groups of -0·6 (95% CI -1·1 to -0·07, p=0·0257).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628912
13HumanRandomized controlled trialSafety outcome
In overweight adults with type 1 diabetes, nausea was more frequent with liraglutide (58%) than with placebo (10%).
In plain wordsIn overweight adults with type 1 diabetes, nausea was more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseNausea
Study
n = 100
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Nausea
58%
liraglutide
Nausea
10%
placebo
Source sentences
Summary
nausea (29 [58%] patients with liraglutide vs five [10%] with placebo)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628913
14HumanRandomized controlled trialSafety outcome
In overweight adults with type 1 diabetes, dyspepsia was more frequent with liraglutide (22%) than with placebo (2%).
In plain wordsIn overweight adults with type 1 diabetes, indigestion was more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseDyspepsia
Study
n = 100
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Dyspepsia
22%
liraglutide
Dyspepsia
2%
placebo
Source sentences
Summary
dyspepsia (11 [22%] patients with liraglutide vs one [2%] with placebo)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628914
15HumanRandomized controlled trialSafety outcome
In overweight adults with type 1 diabetes, diarrhoea was more frequent with liraglutide (20%) than with placebo (2%).
In plain wordsIn overweight adults with type 1 diabetes, diarrhoea was more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseDiarrhoea
Study
n = 100
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Diarrhoea
20%
liraglutide
Diarrhoea
2%
placebo
Source sentences
Summary
diarrhoea (ten [20%] patients with liraglutide vs one [2%] with placebo)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628915
16HumanRandomized controlled trialSafety outcome
In overweight adults with type 1 diabetes, decreased appetite occurred in 14% of patients with liraglutide and in none with placebo.
In plain wordsIn overweight adults with type 1 diabetes, decreased appetite occurred with liraglutide but not with placebo.
Peptide
Liraglutide
Outcome
IncreaseDecreased appetite
Study
n = 100
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Decreased appetite
14%
liraglutide
Source sentences
Summary
decreased appetite (seven patients [14%] with liraglutide vs none with placebo)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628916
17HumanRandomized controlled trialSafety outcome
In overweight adults with type 1 diabetes, vomiting was more frequent with liraglutide (14%) than with placebo (2%).
In plain wordsIn overweight adults with type 1 diabetes, vomiting was more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseVomiting
Study
n = 100
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Vomiting
14%
liraglutide
Vomiting
2%
placebo
Source sentences
Summary
vomiting (seven [14%] patients with liraglutide vs one [2%] with placebo)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628917
18HumanRandomized controlled trialSafety outcome
In overweight adults with type 1 diabetes, four patients on liraglutide and six on placebo discontinued treatment before 24 weeks.
In plain wordsIn overweight adults with type 1 diabetes, four patients on liraglutide and six on placebo stopped treatment before 24 weeks.
Peptide
Liraglutide
Outcome
Not applicableTreatment discontinuation before 24 weeks
Study
n = 100
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
0·6 mg per day escalated to 1·8 mg per day · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Four patients from the liraglutide group and six patients from the placebo group discontinued treatment before 24 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 18 years or older with type 1 diabetes, insufficient glycaemic control (HbA1c >8% [64 mmol/mol]), and overweight (BMI >25 kg/m(2)) were randomly assigned (1:1) to receive insulin treatment plus either liraglutide or placebo (saline solution) by subcutaneous injection once per day.
Report a problemFND-2665628918

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

Registered trials1

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

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT01612468

Liraglutide in Type 1 Diabetes

Steno Diabetes Center Copenhagenn = 100Jun 2012 to Feb 2015

Diabetes Mellitus, Type 1 · Overweight

Trial page ClinicalTrials.govUpdated 27 Jan 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
12 Oct 2026, 12:10 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.

Publication types

MeSH terms

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