Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks.

Kuhadiya ND, Dhindsa S, Ghanim H, Mehta A, Makdissi A, Batra M, Sandhu S, Hejna J, Green K, Bellini N, Yang M, Chaudhuri A, Dandona P

Diabetes care5 Apr 2016Cited by 84 (Europe PMC)

PMID27208343PMCIDPMC5864130DOI10.2337/dc15-1136PepBankPUB-27208343

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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 study16

16 results from studies that gave the peptide. 16 results from people.

01HumanRandomized controlled trialSafety outcome
In adults with type 1 diabetes on insulin, liraglutide led to more gastrointestinal adverse events than placebo.
In plain wordsIn adults with type 1 diabetes using insulin, liraglutide caused more stomach and bowel side effects than placebo.
Peptide
Liraglutide
Outcome
IncreaseGastrointestinal adverse events
Study
n = 72
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.6, 1.2 and 1.8 mg daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Liraglutide led to higher gastrointestinal adverse events (P < 0.05)
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834315
02HumanRandomized controlled trialSafety outcome
In adults with type 1 diabetes on insulin, liraglutide produced increases of 1% or less in time in hypoglycemia that were not significant.
In plain wordsIn adults with type 1 diabetes using insulin, time with low blood sugar rose by 1% or less with liraglutide, not significantly.
Peptide
Liraglutide
Outcome
No significant changeTime spent in hypoglycemia
Study
n = 72
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.6, 1.2 and 1.8 mg daily · 12 weeksAs given in this study (human).
Source sentences
Summary
and ≤1% increases (not significant) in percent time spent in hypoglycemia (<55 mg/dL, 3.05 mmol/L).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834316
03HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on insulin, liraglutide 1.2 mg lowered mean weekly average blood glucose versus placebo.
In plain wordsIn adults with type 1 diabetes using insulin, liraglutide 1.2 mg lowered average blood glucose compared with placebo.
Peptide
Liraglutide
Outcome
DecreaseWeekly reduction in average blood glucose, 1.2 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 mg daily · 12 weeksAs given in this study (human).
Measurements
Mean weekly reduction in average blood glucose
−0.55 mmol/L
1.2 mg
Source sentences
Summary
In the 1.2-mg and 1.8-mg groups, the mean weekly reduction in average blood glucose was -0.55 ± 0.11 mmol/L (10 ± 2 mg/dL) and -0.55 ± 0.05 mmol/L (10 ± 1 mg/dL), respectively (P < 0.0001), while it remained unchanged in the 0.6-mg and placebo groups.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834301
04HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on insulin, liraglutide 1.8 mg lowered mean weekly average blood glucose versus placebo.
In plain wordsIn adults with type 1 diabetes using insulin, liraglutide 1.8 mg lowered average blood glucose compared with placebo.
Peptide
Liraglutide
Outcome
DecreaseWeekly reduction in average blood glucose, 1.8 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg daily · 12 weeksAs given in this study (human).
Measurements
Mean weekly reduction in average blood glucose
−0.55 mmol/L
1.8 mg
Source sentences
Summary
In the 1.2-mg and 1.8-mg groups, the mean weekly reduction in average blood glucose was -0.55 ± 0.11 mmol/L (10 ± 2 mg/dL) and -0.55 ± 0.05 mmol/L (10 ± 1 mg/dL), respectively (P < 0.0001), while it remained unchanged in the 0.6-mg and placebo groups.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834302
05HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on insulin, average blood glucose stayed unchanged with liraglutide 0.6 mg.
In plain wordsIn adults with type 1 diabetes using insulin, liraglutide 0.6 mg did not change average blood glucose.
Peptide
Liraglutide
Outcome
No significant changeWeekly reduction in average blood glucose, 0.6 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg daily · 12 weeksAs given in this study (human).
Source sentences
Summary
In the 1.2-mg and 1.8-mg groups, the mean weekly reduction in average blood glucose was -0.55 ± 0.11 mmol/L (10 ± 2 mg/dL) and -0.55 ± 0.05 mmol/L (10 ± 1 mg/dL), respectively (P < 0.0001), while it remained unchanged in the 0.6-mg and placebo groups.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834303
06HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on insulin, HbA1c fell significantly with liraglutide 1.2 mg (-0.78%), and it also fell by 0.3% in the placebo group.
In plain wordsIn adults with type 1 diabetes using insulin, HbA1c fell with liraglutide 1.2 mg, and it also fell a little in the placebo group.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change, 1.2 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 mg daily · 12 weeksAs given in this study (human).
Measurements
HbA1c change
−0.78%
1.2 mg
Source sentences
Summary
In the 1.2-mg group, HbA1c fell significantly (-0.78 ± 15%, -8.5 ± 1.6 mmol/mol, P < 0.01), while it did not in the 1.8-mg group (-0.42 ± 0.15%, -4.6 ± 1.6 mmol/mol, P = 0.39) and 0.6-mg group (-0.26 ± 0.17%, -2.8 ± 1.9 mmol/mol, P = 0.81) vs. the placebo group (-0.3 ± 0.15%, -3.3 ± 1.6 mmol/mol).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834304
07HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on insulin, HbA1c did not fall significantly with liraglutide 1.8 mg versus placebo.
In plain wordsIn adults with type 1 diabetes using insulin, liraglutide 1.8 mg did not lower HbA1c significantly compared with placebo.
Peptide
Liraglutide
Outcome
No significant changeHbA1c change, 1.8 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg daily · 12 weeksAs given in this study (human).
Measurements
HbA1c change
−0.42%
1.8 mg
Source sentences
Summary
In the 1.2-mg group, HbA1c fell significantly (-0.78 ± 15%, -8.5 ± 1.6 mmol/mol, P < 0.01), while it did not in the 1.8-mg group (-0.42 ± 0.15%, -4.6 ± 1.6 mmol/mol, P = 0.39) and 0.6-mg group (-0.26 ± 0.17%, -2.8 ± 1.9 mmol/mol, P = 0.81) vs. the placebo group (-0.3 ± 0.15%, -3.3 ± 1.6 mmol/mol).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834305
08HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on insulin, HbA1c did not fall significantly with liraglutide 0.6 mg versus placebo.
In plain wordsIn adults with type 1 diabetes using insulin, liraglutide 0.6 mg did not lower HbA1c significantly compared with placebo.
Peptide
Liraglutide
Outcome
No significant changeHbA1c change, 0.6 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg daily · 12 weeksAs given in this study (human).
Measurements
HbA1c change
−0.26%
0.6 mg
Source sentences
Summary
In the 1.2-mg group, HbA1c fell significantly (-0.78 ± 15%, -8.5 ± 1.6 mmol/mol, P < 0.01), while it did not in the 1.8-mg group (-0.42 ± 0.15%, -4.6 ± 1.6 mmol/mol, P = 0.39) and 0.6-mg group (-0.26 ± 0.17%, -2.8 ± 1.9 mmol/mol, P = 0.81) vs. the placebo group (-0.3 ± 0.15%, -3.3 ± 1.6 mmol/mol).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834306
09HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on insulin, liraglutide 1.2 mg reduced glycemic variability.
In plain wordsIn adults with type 1 diabetes using insulin, liraglutide 1.2 mg made glucose swings smaller.
Peptide
Liraglutide
Outcome
DecreaseGlycemic variability, 1.2 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 mg daily · 12 weeksAs given in this study (human).
Measurements
Reduction in glycemic variability
5%
1.2 mg
Source sentences
Summary
Glycemic variability was reduced by 5 ± 1% (P < 0.01) in the 1.2-mg group only.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834307
10HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes on insulin, glycemic variability was reduced only in the 1.2 mg group, not with 0.6 mg or 1.8 mg.
In plain wordsIn adults with type 1 diabetes using insulin, liraglutide 0.6 mg and 1.8 mg did not reduce glucose swings.
Peptide
Liraglutide
Outcome
No significant changeGlycemic variability, 0.6 mg and 1.8 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg and 1.8 mg daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Glycemic variability was reduced by 5 ± 1% (P < 0.01) in the 1.2-mg group only.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834308
11HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, total daily insulin dose fell significantly with liraglutide 1.2 mg and 1.8 mg.
In plain wordsIn adults with type 1 diabetes, people on liraglutide 1.2 mg or 1.8 mg needed less insulin per day.
Peptide
Liraglutide
Outcome
DecreaseTotal daily insulin dose, 1.2 mg and 1.8 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 mg and 1.8 mg daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Total daily insulin dose fell significantly only in the 1.2-mg and 1.8-mg groups (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834309
12HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, total daily insulin dose did not fall significantly with liraglutide 0.6 mg.
In plain wordsIn adults with type 1 diabetes, liraglutide 0.6 mg did not reduce the daily insulin dose significantly.
Peptide
Liraglutide
Outcome
No significant changeTotal daily insulin dose, 0.6 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Total daily insulin dose fell significantly only in the 1.2-mg and 1.8-mg groups (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834310
13HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, liraglutide 1.2 mg and 1.8 mg led to weight loss, with none in the placebo group.
In plain wordsIn adults with type 1 diabetes, people on liraglutide 1.2 mg or 1.8 mg lost weight, while people on placebo did not.
Peptide
Liraglutide
Outcome
DecreaseBody weight loss, 1.2 mg and 1.8 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg and 1.8 mg daily · 12 weeksAs given in this study (human).
Measurements
Weight loss
5 kg
1.2 mg and 1.8 mg
Source sentences
Summary
There was a 5 ± 1 kg weight loss in the two higher-dose groups (P < 0.05) and by 2.7 ± 0.6 kg (P < 0.01) in the 0.6-mg group vs. none in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834311
14HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, liraglutide 0.6 mg led to weight loss, with none in the placebo group.
In plain wordsIn adults with type 1 diabetes, people on liraglutide 0.6 mg lost weight, while people on placebo did not.
Peptide
Liraglutide
Outcome
DecreaseBody weight loss, 0.6 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
0.6 mg daily · 12 weeksAs given in this study (human).
Measurements
Weight loss
2.7 kg
0.6 mg
Source sentences
Summary
There was a 5 ± 1 kg weight loss in the two higher-dose groups (P < 0.05) and by 2.7 ± 0.6 kg (P < 0.01) in the 0.6-mg group vs. none in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834312
15HumanRandomized controlled trialMechanism
In adults with type 1 diabetes on insulin, postprandial plasma glucagon fell with liraglutide 1.2 mg.
In plain wordsIn adults with type 1 diabetes using insulin, glucagon after meals fell with liraglutide 1.2 mg.
Peptide
Liraglutide
Outcome
DecreasePostprandial plasma glucagon, 1.2 mg
Study
n: not reported in source
Outcome group
Hormone levels · Endocrine and hormones
Studied dose
1.2 mg daily · 12 weeksAs given in this study (human).
Measurements
Fall in postprandial plasma glucagon
72%
1.2 mg
Source sentences
Summary
In the 1.2- and 1.8-mg groups, postprandial plasma glucagon concentration fell by 72 ± 12% and 47 ± 12%, respectively (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834313
16HumanRandomized controlled trialMechanism
In adults with type 1 diabetes on insulin, postprandial plasma glucagon fell with liraglutide 1.8 mg.
In plain wordsIn adults with type 1 diabetes using insulin, glucagon after meals fell with liraglutide 1.8 mg.
Peptide
Liraglutide
Outcome
DecreasePostprandial plasma glucagon, 1.8 mg
Study
n: not reported in source
Outcome group
Hormone levels · Endocrine and hormones
Studied dose
1.8 mg daily · 12 weeksAs given in this study (human).
Measurements
Fall in postprandial plasma glucagon
47%
1.8 mg
Source sentences
Summary
In the 1.2- and 1.8-mg groups, postprandial plasma glucagon concentration fell by 72 ± 12% and 47 ± 12%, respectively (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.
Report a problemFND-2720834314

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01722266

Liraglutide in the Treatment of Type 1 Diabetes Mellitus

University at Buffalon = 721 Nov 2012 to 1 Dec 2014

Type 1 Diabetes

Trial page ClinicalTrials.govUpdated 5 Jan 2024

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.

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