Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.

Ahmann A, Rodbard HW, Rosenstock J, Lahtela JT, de Loredo L, Tornøe K, Boopalan A, Nauck MA

Diabetes, obesity & metabolism10 Sept 2015Cited by 83 (Europe PMC)

PMID26179619PMCIDPMC5054929DOI10.1111/dom.12539PepBankPUB-26179619

Read at source 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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, adding liraglutide 1.8 mg lowered HbA1c by 1.3% versus 0.1% with placebo.
In plain wordsIn adults with type 2 diabetes on basal insulin, adding liraglutide lowered HbA1c much more than adding placebo.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change at 26 weeks
Study
n = 451
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
HbA1c change
−1.3%
liraglutide
HbA1c change
−0.1%
placebo
Source sentences
Summary
After 26 weeks, HbA1c decreased more with liraglutide [-1.3% (-14.2 mmol/mol)] than with placebo [-0.1% (-1.2 mmol/mol); p < 0.0001].
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961901
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, more subjects on liraglutide reached HbA1c below 7.0% than on placebo (59% vs 14%).
In plain wordsIn adults with type 2 diabetes on basal insulin, more people on liraglutide than on placebo reached an HbA1c below 7.0%.
Peptide
Liraglutide
Outcome
IncreaseProportion reaching HbA1c below 7.0%
Study
n = 451
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
responders HbA1c <7.0%
59%
liraglutide
responders HbA1c <7.0%
14%
placebo
Source sentences
Summary
More subjects on liraglutide reached HbA1c targets: <7.0% (59% vs 14%; p < 0.0001) and ≤6.5% (43% vs 4%; p < 0.0001)
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961902
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, more subjects on liraglutide reached HbA1c of 6.5% or below than on placebo (43% vs 4%).
In plain wordsIn adults with type 2 diabetes on basal insulin, more people on liraglutide than on placebo reached an HbA1c of 6.5% or below.
Peptide
Liraglutide
Outcome
IncreaseProportion reaching HbA1c 6.5% or below
Study
n = 451
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
responders HbA1c <=6.5%
43%
liraglutide
responders HbA1c <=6.5%
4%
placebo
Source sentences
Summary
More subjects on liraglutide reached HbA1c targets: <7.0% (59% vs 14%; p < 0.0001) and ≤6.5% (43% vs 4%; p < 0.0001)
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961903
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, subjects on liraglutide used slightly less insulin than those on placebo (35.8 IU vs 40.1 IU).
In plain wordsIn adults with type 2 diabetes on basal insulin, people on liraglutide used slightly less insulin than people on placebo.
Peptide
Liraglutide
Outcome
DecreaseInsulin dose
Study
n = 451
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
insulin dose
35.8 IU
liraglutide
insulin dose
40.1 IU
placebo
Source sentences
Summary
using slightly less insulin (35.8 IU vs 40.1 IU).
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961904
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, liraglutide decreased fasting plasma glucose more than placebo (estimated treatment difference -1.3 mmol/l).
In plain wordsIn adults with type 2 diabetes on basal insulin, liraglutide lowered fasting blood sugar more than placebo.
Peptide
Liraglutide
Outcome
DecreaseFasting plasma glucose
Study
n = 451
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
estimated treatment difference
−1.3 mmol/l
fasting plasma glucose
Source sentences
Summary
Greater decreases from baseline (estimated treatment differences vs placebo; p < 0.0001) occurred in fasting plasma glucose (-1.3 mmol/l), seven-point glucose profiles (-1.6 mmol/l), body weight (-3.1 kg) and systolic blood pressure (-5.0 mmHg).
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961905
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, liraglutide decreased seven-point glucose profiles more than placebo (estimated treatment difference -1.6 mmol/l).
In plain wordsIn adults with type 2 diabetes on basal insulin, liraglutide lowered blood sugar through the day more than placebo.
Peptide
Liraglutide
Outcome
DecreaseSeven-point glucose profile
Study
n = 451
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
estimated treatment difference
−1.6 mmol/l
seven-point glucose profile
Source sentences
Summary
Greater decreases from baseline (estimated treatment differences vs placebo; p < 0.0001) occurred in fasting plasma glucose (-1.3 mmol/l), seven-point glucose profiles (-1.6 mmol/l), body weight (-3.1 kg) and systolic blood pressure (-5.0 mmHg).
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961906
07HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, liraglutide decreased body weight more than placebo (estimated treatment difference -3.1 kg).
In plain wordsIn adults with type 2 diabetes on basal insulin, liraglutide lowered body weight more than placebo.
Peptide
Liraglutide
Outcome
DecreaseBody weight change
Study
n = 451
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
estimated treatment difference
−3.1 kg
body weight
Source sentences
Summary
Greater decreases from baseline (estimated treatment differences vs placebo; p < 0.0001) occurred in fasting plasma glucose (-1.3 mmol/l), seven-point glucose profiles (-1.6 mmol/l), body weight (-3.1 kg) and systolic blood pressure (-5.0 mmHg).
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961907
08HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, liraglutide decreased systolic blood pressure more than placebo (estimated treatment difference -5.0 mmHg).
In plain wordsIn adults with type 2 diabetes on basal insulin, liraglutide lowered systolic blood pressure more than placebo.
Peptide
Liraglutide
Outcome
DecreaseSystolic blood pressure
Study
n = 451
Comparator
Placebo
Outcome group
Blood pressure · Cardiovascular
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
estimated treatment difference
−5 mmHg
systolic blood pressure
Source sentences
Summary
Greater decreases from baseline (estimated treatment differences vs placebo; p < 0.0001) occurred in fasting plasma glucose (-1.3 mmol/l), seven-point glucose profiles (-1.6 mmol/l), body weight (-3.1 kg) and systolic blood pressure (-5.0 mmHg).
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961908
09HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, transient nausea was more frequent with liraglutide than with placebo (22.2% vs 3.1%).
In plain wordsIn adults with type 2 diabetes on basal insulin, nausea was more common with liraglutide than with placebo, and it was transient.
Peptide
Liraglutide
Outcome
IncreaseNausea
Study
n = 451
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
nausea
22.2%
liraglutide
nausea
3.1%
placebo
Source sentences
Summary
Transient gastrointestinal adverse events (nausea: 22.2% vs 3.1%) and minor hypoglycaemia (18.2% vs 12.4%) were more frequent with liraglutide than placebo, and pulse increased (4.5 beats/min) compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961909
10HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, minor hypoglycaemia was more frequent with liraglutide than with placebo (18.2% vs 12.4%).
In plain wordsIn adults with type 2 diabetes on basal insulin, minor low blood sugar was more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseMinor hypoglycaemia
Study
n = 451
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
minor hypoglycaemia
18.2%
liraglutide
minor hypoglycaemia
12.4%
placebo
Source sentences
Summary
Transient gastrointestinal adverse events (nausea: 22.2% vs 3.1%) and minor hypoglycaemia (18.2% vs 12.4%) were more frequent with liraglutide than placebo, and pulse increased (4.5 beats/min) compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961910
11HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, pulse increased by 4.5 beats/min with liraglutide compared with placebo.
In plain wordsIn adults with type 2 diabetes on basal insulin, pulse rate rose with liraglutide compared with placebo.
Peptide
Liraglutide
Outcome
IncreasePulse rate
Study
n = 451
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
pulse increase
4.5 beats/min
liraglutide versus placebo
Source sentences
Summary
and pulse increased (4.5 beats/min) compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961911
12HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, no severe hypoglycaemia occurred.
In plain wordsIn adults with type 2 diabetes on basal insulin, no severe low blood sugar occurred in the trial.
Peptide
Liraglutide
Outcome
No significant changeSevere hypoglycaemia
Study
n = 451
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycaemia or pancreatitis occurred.
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961912
13HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, no pancreatitis occurred.
In plain wordsIn adults with type 2 diabetes on basal insulin, no pancreatitis occurred in the trial.
Peptide
Liraglutide
Outcome
No significant changePancreatitis
Study
n = 451
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycaemia or pancreatitis occurred.
1 context sentence(design, population, supporting numbers)
Summary · context
To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].
Report a problemFND-2617961913

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 postedNCT01617434

The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 451Sept 2012 to Oct 2013

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 8 Mar 2017

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

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Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.

Summary

Results from this study13

Registered trials1

The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

Version history

Subjects

Publication types

MeSH terms

Keywords