Effect of Adding Liraglutide vs Placebo to a High-Dose lnsulin Regimen in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Vanderheiden A, Harrison L, Warshauer J, Li X, Adams-Huet B, Lingvay I

JAMA internal medicine1 Jul 2016Cited by 33 (Europe PMC)

PMID27273731DOI10.1001/jamainternmed.2016.1540PepBankPUB-27273731

Publisher page PubMedAsk about this study

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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with uncontrolled type 2 diabetes on high-dose insulin, adding liraglutide lowered HbA1c versus placebo.
In plain wordsIn adults with uncontrolled type 2 diabetes on high-dose insulin, adding liraglutide lowered HbA1c more than placebo.
Peptide
Liraglutide
Outcome
DecreaseChange in glycated hemoglobin
Study
n = 71
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg/d · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Estimated treatment difference in HbA1c
0.9%
95% CI -1.5 to -0.4
Source sentences
Summary
The glycated hemoglobin level improved from a mean (SD) of 9.0% (1.2%) to 7.9% (1.1%) in the liraglutide group (P < .001) and remained unchanged (8.9%) in the placebo group, with an estimated treatment difference of 0.9% (95% CI, -1.5 to -0.4) (P = .002).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome was the change in glycated hemoglobin level.
Summary · context
Participants were 71 patients with uncontrolled type 2 diabetes (glycated hemoglobin level, 7.5%-11.0%) using more than 1.5 U/kg/d of insulin.
Summary · context
Subcutaneous injection of liraglutide (1.8 mg/d) or matching placebo for 6 months.
Report a problemFND-2727373101
02HumanRandomized controlled trialEfficacy outcome
In adults with uncontrolled type 2 diabetes on high-dose insulin, weight decreased with liraglutide while it rose with placebo.
In plain wordsIn adults with uncontrolled type 2 diabetes on high-dose insulin, liraglutide lowered weight while placebo led to weight gain.
Peptide
Liraglutide
Outcome
DecreaseChange in body weight
Study
n = 71
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.8 mg/d · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Treatment difference in weight
−2.3 kg
95% CI -4.3 to -0.4
Source sentences
Summary
Weight decreased from a mean (SD) of 114.6 (21.4) kg to 113.6 (20.8) kg in the liraglutide group vs a mean (SD) increase from 116.1 (26.6) kg to 117.2 (27.2) kg in the placebo group, with a treatment difference of -2.3 kg (95% CI, -4.3 to -0.4 kg) (P = .02).
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes were changes in weight, hypoglycemia rate, insulin dosage, and quality-of-life measures.
Summary · context
Participants were 71 patients with uncontrolled type 2 diabetes (glycated hemoglobin level, 7.5%-11.0%) using more than 1.5 U/kg/d of insulin.
Summary · context
Subcutaneous injection of liraglutide (1.8 mg/d) or matching placebo for 6 months.
Report a problemFND-2727373102
03HumanRandomized controlled trialEfficacy outcome
In adults with uncontrolled type 2 diabetes on high-dose insulin, the total daily insulin dose decreased 11.5% with liraglutide, a change that was not significant (P = .20).
In plain wordsIn adults with uncontrolled type 2 diabetes on high-dose insulin, the daily insulin dose fell by 11.5% with liraglutide, but this was not significant.
Peptide
Liraglutide
Outcome
No significant changeChange in total daily insulin dose
Study
n = 71
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg/d · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Decrease in total daily insulin dose
11.5%
liraglutide
Source sentences
Summary
The total daily dose of insulin decreased 11.5% (95% CI, -21.8% to -1.1%) in the liraglutide group (P = .20).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were 71 patients with uncontrolled type 2 diabetes (glycated hemoglobin level, 7.5%-11.0%) using more than 1.5 U/kg/d of insulin.
Summary · context
Subcutaneous injection of liraglutide (1.8 mg/d) or matching placebo for 6 months.
Report a problemFND-2727373103
04HumanRandomized controlled trialSafety outcome
In adults with uncontrolled type 2 diabetes on high-dose insulin, the hypoglycemia rate in the first month after starting liraglutide was higher than with placebo.
In plain wordsIn adults with uncontrolled type 2 diabetes on high-dose insulin, low blood sugar was more frequent in the first month of liraglutide than of placebo.
Peptide
Liraglutide
Outcome
IncreaseHypoglycemia rate in the first month
Study
n = 71
Comparator
Placebo
Analysis
Secondary
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg/d · subcutaneous · 1 monthAs given in this study (human).
Measurements
Hypoglycemia rate
2.3 events per person-month
liraglutide, first month
Hypoglycemia rate
0.91 events per person-month
placebo, first month
Source sentences
Summary
The hypoglycemia rate was higher in the first month after initiation of liraglutide compared with placebo (2.30 vs 0.91 events per person-month, P = .01)
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were 71 patients with uncontrolled type 2 diabetes (glycated hemoglobin level, 7.5%-11.0%) using more than 1.5 U/kg/d of insulin.
Summary · context
Subcutaneous injection of liraglutide (1.8 mg/d) or matching placebo for 6 months.
Report a problemFND-2727373104
05HumanRandomized controlled trialSafety outcome
In adults with uncontrolled type 2 diabetes on high-dose insulin, the overall hypoglycemia rate over the whole follow-up was similar between liraglutide and placebo.
In plain wordsIn adults with uncontrolled type 2 diabetes on high-dose insulin, overall low blood sugar over six months was similar with liraglutide and placebo.
Peptide
Liraglutide
Outcome
No significant changeOverall hypoglycemia rate over follow-up
Study
n = 71
Comparator
Placebo
Analysis
Secondary
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg/d · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
while the overall hypoglycemia rate over the entire follow-up was similar between groups (P = .11).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were 71 patients with uncontrolled type 2 diabetes (glycated hemoglobin level, 7.5%-11.0%) using more than 1.5 U/kg/d of insulin.
Summary · context
Subcutaneous injection of liraglutide (1.8 mg/d) or matching placebo for 6 months.
Report a problemFND-2727373105
06HumanRandomized controlled trialEfficacy outcome
In adults with uncontrolled type 2 diabetes on high-dose insulin, glycemia control perception improved more with liraglutide than with placebo.
In plain wordsIn adults with uncontrolled type 2 diabetes on high-dose insulin, people felt their blood sugar control improved more with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseGlycemia control perception
Study
n = 71
Comparator
Placebo
Analysis
Secondary
Outcome group
Quality of life · Whole body
Studied dose
1.8 mg/d · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Glycemia control perception, satisfaction with insulin treatment, and willingness to continue insulin use improved more in the liraglutide group.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were 71 patients with uncontrolled type 2 diabetes (glycated hemoglobin level, 7.5%-11.0%) using more than 1.5 U/kg/d of insulin.
Summary · context
Subcutaneous injection of liraglutide (1.8 mg/d) or matching placebo for 6 months.
Report a problemFND-2727373106
07HumanRandomized controlled trialEfficacy outcome
In adults with uncontrolled type 2 diabetes on high-dose insulin, satisfaction with insulin treatment improved more with liraglutide than with placebo.
In plain wordsIn adults with uncontrolled type 2 diabetes on high-dose insulin, satisfaction with insulin treatment improved more with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseSatisfaction with insulin treatment
Study
n = 71
Comparator
Placebo
Analysis
Secondary
Outcome group
Quality of life · Whole body
Studied dose
1.8 mg/d · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Glycemia control perception, satisfaction with insulin treatment, and willingness to continue insulin use improved more in the liraglutide group.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were 71 patients with uncontrolled type 2 diabetes (glycated hemoglobin level, 7.5%-11.0%) using more than 1.5 U/kg/d of insulin.
Summary · context
Subcutaneous injection of liraglutide (1.8 mg/d) or matching placebo for 6 months.
Report a problemFND-2727373107
08HumanRandomized controlled trialEfficacy outcome
In adults with uncontrolled type 2 diabetes on high-dose insulin, willingness to continue insulin use improved more with liraglutide than with placebo.
In plain wordsIn adults with uncontrolled type 2 diabetes on high-dose insulin, willingness to continue insulin improved more with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseWillingness to continue insulin use
Study
n = 71
Comparator
Placebo
Analysis
Secondary
Outcome group
Quality of life · Whole body
Studied dose
1.8 mg/d · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Glycemia control perception, satisfaction with insulin treatment, and willingness to continue insulin use improved more in the liraglutide group.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were 71 patients with uncontrolled type 2 diabetes (glycated hemoglobin level, 7.5%-11.0%) using more than 1.5 U/kg/d of insulin.
Summary · context
Subcutaneous injection of liraglutide (1.8 mg/d) or matching placebo for 6 months.
Report a problemFND-2727373108

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 4Results postedNCT01505673

Adding Liraglutide to High Dose Insulin: Breaking the Cycle

Ildiko Lingvayn = 71Jan 2012 to Jun 2016

Type 2 Diabetes Mellitus · Obesity

Trial page ClinicalTrials.govUpdated 16 Jan 2018

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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