Twelve-Week Treatment With Liraglutide as Add-on to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes: A Randomized, Placebo-Controlled, Double-Blind Parallel Study.

Frandsen CS, Dejgaard TF, Holst JJ, Andersen HU, Thorsteinsson B, Madsbad S

Diabetes care20 Oct 2015Cited by 83 (Europe PMC)

PMID26486191DOI10.2337/dc15-1037PepBankPUB-26486191

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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In normal-weight adults with poorly controlled type 1 diabetes on insulin, the HbA1c change with liraglutide did not differ from placebo.
In plain wordsIn normal-weight adults with poorly controlled type 1 diabetes, HbA1c fell by a similar amount with liraglutide and with placebo.
Peptide
Liraglutide
Outcome
No significant changeHbA1c change from baseline
Study
n = 40
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 mg once daily · 12 weeksAs given in this study (human).
Measurements
HbA1c change
−0.6%
liraglutide
HbA1c change
−0.5%
placebo
Source sentences
Summary
Change in HbA1c from baseline was -0.6 ± 0.2% (-6.22 ± 1.71 mmol/mol) with liraglutide and -0.5 ± 0.2% (-5.56 ± 1.67 mmol/mol) with placebo (P = 0.62).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary end point was change in HbA1c.
Summary · context
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks.
Report a problemFND-2648619101
02HumanRandomized controlled trialEfficacy outcome
In normal-weight adults with poorly controlled type 1 diabetes on insulin, variation in glycemic excursions did not change in either the liraglutide or the placebo group.
In plain wordsIn normal-weight adults with poorly controlled type 1 diabetes, blood sugar swings did not change with liraglutide or with placebo.
Peptide
Liraglutide
Outcome
No significant changeGlycemic excursions
Study
n = 40
Comparator
Baseline
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 mg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Variation in glycemic excursions did not change in either group.
1 context sentence(design, population, supporting numbers)
Summary · context
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks.
Report a problemFND-2648619102
03HumanRandomized controlled trialEfficacy outcome
In normal-weight adults with poorly controlled type 1 diabetes on insulin, liraglutide reduced body weight whereas weight rose with placebo.
In plain wordsIn normal-weight adults with poorly controlled type 1 diabetes, liraglutide lowered body weight while placebo was linked to weight gain.
Peptide
Liraglutide
Outcome
DecreaseBody weight change
Study
n = 40
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg once daily · 12 weeksAs given in this study (human).
Measurements
Body weight change
−3.13 kg
liraglutide
Body weight change
1.12 kg
placebo
Source sentences
Summary
Change in body weight was -3.13 ± 0.58 and +1.12 ± 0.42 kg (P < 0.0001) with liraglutide and placebo, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks.
Report a problemFND-2648619103
04HumanRandomized controlled trialEfficacy outcome
In normal-weight adults with poorly controlled type 1 diabetes on insulin, the bolus insulin dose decreased with liraglutide and did not change with placebo.
In plain wordsIn normal-weight adults with poorly controlled type 1 diabetes, people on liraglutide needed less mealtime insulin, but people on placebo did not.
Peptide
Liraglutide
Outcome
DecreaseBolus insulin dose
Study
n = 40
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 mg once daily · 12 weeksAs given in this study (human).
Measurements
Bolus insulin dose decrease
4 IU
liraglutide
Bolus insulin dose change
0 IU
placebo
Source sentences
Summary
The bolus insulin dose decreased in liraglutide-treated patients and did not change with placebo treatment (4.0 ± 1.3 vs. 0.0 ± 1.0 IU, P = 0.02).
1 context sentence(design, population, supporting numbers)
Summary · context
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks.
Report a problemFND-2648619104
05HumanRandomized controlled trialEfficacy outcome
In normal-weight adults with poorly controlled type 1 diabetes on insulin, heart rate increased within the liraglutide group.
In plain wordsIn normal-weight adults with poorly controlled type 1 diabetes, heart rate rose over time in people taking liraglutide.
Peptide
Liraglutide
Outcome
IncreaseHeart rate within the liraglutide group
Study
n = 40
Comparator
Baseline
Analysis
Secondary
Outcome group
Heart function · Cardiovascular
Studied dose
1.2 mg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Heart rate increased within the liraglutide group (P = 0.04)
1 context sentence(design, population, supporting numbers)
Summary · context
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks.
Report a problemFND-2648619105
06HumanRandomized controlled trialEfficacy outcome
In normal-weight adults with poorly controlled type 1 diabetes on insulin, the heart rate increase with liraglutide was not significant compared with placebo.
In plain wordsIn normal-weight adults with poorly controlled type 1 diabetes, the rise in heart rate with liraglutide was not significant compared with placebo.
Peptide
Liraglutide
Outcome
No significant changeHeart rate versus placebo
Study
n = 40
Comparator
Placebo
Analysis
Secondary
Outcome group
Heart function · Cardiovascular
Studied dose
1.2 mg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Heart rate increased within the liraglutide group (P = 0.04) but not compared with placebo
1 context sentence(design, population, supporting numbers)
Summary · context
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks.
Report a problemFND-2648619106
07HumanRandomized controlled trialEfficacy outcome
In normal-weight adults with poorly controlled type 1 diabetes on insulin, mean systolic blood pressure decreased with liraglutide compared with placebo.
In plain wordsIn normal-weight adults with poorly controlled type 1 diabetes, systolic blood pressure fell more with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
DecreaseMean systolic blood pressure
Study
n = 40
Comparator
Placebo
Analysis
Secondary
Outcome group
Blood pressure · Cardiovascular
Studied dose
1.2 mg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
mean systolic blood pressure decreased compared with placebo (between-group difference 3.21 mmHg [95% CI -8.31 to 1.90], P = 0.04).
1 context sentence(design, population, supporting numbers)
Summary · context
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks.
Report a problemFND-2648619107
08HumanRandomized controlled trialSafety outcome
In normal-weight adults with poorly controlled type 1 diabetes on insulin, gastrointestinal adverse effects were more frequent with liraglutide than with placebo.
In plain wordsIn normal-weight adults with poorly controlled type 1 diabetes, liraglutide caused more stomach and gut side effects than placebo.
Peptide
Liraglutide
Outcome
IncreaseGastrointestinal adverse effects
Study
n = 40
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.2 mg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Liraglutide was more frequently associated with gastrointestinal adverse effects.
1 context sentence(design, population, supporting numbers)
Summary · context
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks.
Report a problemFND-2648619108
09HumanRandomized controlled trialSafety outcome
In normal-weight adults with poorly controlled type 1 diabetes on insulin, the incidence of hypoglycemia did not differ between liraglutide and placebo.
In plain wordsIn normal-weight adults with poorly controlled type 1 diabetes, low blood sugar episodes were equally common with liraglutide and with placebo.
Peptide
Liraglutide
Outcome
No significant changeIncidence of hypoglycemia
Study
n = 40
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.2 mg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
The incidence of hypoglycemia did not differ between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks.
Report a problemFND-2648619109

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 3NCT02092896

Liraglutide as add-on to Insulin in Type 1 Diabetes

Hvidovre University Hospitaln = 40Mar 2013 to Oct 2014

Diabetes · Diabetes Mellitus, Type 1

Trial page ClinicalTrials.govUpdated 1 Apr 2015

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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