Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes.

Gough SC, Bode B, Woo V, Rodbard HW, Linjawi S, Poulsen P, Damgaard LH, Buse JB

The lancet. Diabetes & endocrinology1 Sept 2014Cited by 264 (Europe PMC)

PMID25190523DOI10.1016/s2213-8587(14)70174-3PepBankPUB-25190523

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 study14

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

01HumanRandomized controlled trialEfficacy outcome
In insulin-naive adults with type 2 diabetes, adding liraglutide (IDegLira versus insulin degludec) lowered HbA1c by an estimated 0.47 percentage points more at 26 weeks, meeting non-inferiority.
In plain wordsIn adults with type 2 diabetes, the insulin plus liraglutide combination lowered HbA1c more than insulin degludec alone after 26 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change, IDegLira versus insulin degludec
Study
n: not reported in source
Comparator
Insulin degludec
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Estimated treatment difference
−0.47%
IDegLira vs insulin degludec
Source sentences
Summary
IDegLira was non-inferior to insulin degludec (estimated treatment difference -0·47%, 95% CI -0·58 to -0·36, p<0·0001)
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
Report a problemFND-2519052301
02HumanRandomized controlled trialEfficacy outcome
In insulin-naive adults with type 2 diabetes, HbA1c fell by 1.3% to 7.0% with liraglutide 1.8 mg per day at 26 weeks.
In plain wordsIn adults with type 2 diabetes, HbA1c fell by 1.3% with liraglutide alone after 26 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change with liraglutide alone
Study
n = 415
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg per day · 26 weeksAs given in this study (human).
Measurements
HbA1c decrease
1.3%
liraglutide
Source sentences
Summary
and by 1·3% (1·1) to 7·0% (1·2) with liraglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
Report a problemFND-2519052304
03HumanRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, serious adverse events occurred in 14 (3%) of 412 patients on liraglutide alone.
In plain wordsIn adults with type 2 diabetes, 14 of 412 people (3%) on liraglutide alone had a serious adverse event.
Peptide
Liraglutide
Outcome
Not applicableSerious adverse events with liraglutide alone
Study
n = 412
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg per day · 26 weeksAs given in this study (human).
Measurements
Serious adverse events
14 patients
liraglutide
Source sentences
Summary
and 14 (3%) of 412 in the liraglutide group
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
Report a problemFND-2519052312
04HumanRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, 19.7% of participants on liraglutide 1.8 mg per day reported nausea.
In plain wordsIn adults with type 2 diabetes, 19.7% of people on liraglutide alone reported nausea.
Peptide
Liraglutide
Outcome
Not applicableNausea with liraglutide alone
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.8 mg per day · 26 weeksAs given in this study (human).
Measurements
Nausea
19.7%
liraglutide
Source sentences
Summary
fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8·8 vs 19·7%
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
Report a problemFND-2519052305
05HumanRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, nausea was reported by more participants on IDegLira (8.8%) than on insulin degludec alone (3.6%).
In plain wordsIn adults with type 2 diabetes, nausea was more common with the insulin plus liraglutide combination (8.8%) than with insulin degludec alone (3.6%).
Peptide
Liraglutide
Outcome
IncreaseNausea, IDegLira versus insulin degludec
Study
n: not reported in source
Comparator
Insulin degludec
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Nausea
8.8%
IDegLira
Nausea
3.6%
insulin degludec
Source sentences
Summary
IDegLira was generally well tolerated; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8·8 vs 19·7%), although the insulin degludec group had the fewest participants with gastrointestinal adverse events (nausea 3·6%).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
Report a problemFND-2519052307
06HumanRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, confirmed hypoglycaemic events per patient year were 1.8 with IDegLira and 2.6 with insulin degludec alone; the abstract reports no test.
In plain wordsIn adults with type 2 diabetes, low blood sugar events per patient year were 1.8 with the combination and 2.6 with insulin degludec alone.
Peptide
Liraglutide
Outcome
DecreaseHypoglycaemic events, IDegLira versus insulin degludec
Study
n: not reported in source
Comparator
Insulin degludec
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Confirmed hypoglycaemic events per patient year
1.8 events
IDegLira
Confirmed hypoglycaemic events per patient year
2.6 events
insulin degludec
Source sentences
Summary
The number of confirmed hypoglycaemic events per patient year was 1·8 for IDegLira, 0·2 for liraglutide, and 2·6 for insulin degludec.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
Report a problemFND-2519052309
07HumanRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, liraglutide alone had 0.2 confirmed hypoglycaemic events per patient year.
In plain wordsIn adults with type 2 diabetes, liraglutide alone was linked to 0.2 low blood sugar events per patient year.
Peptide
Liraglutide
Outcome
Not applicableConfirmed hypoglycaemic events with liraglutide alone
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg per day · 26 weeksAs given in this study (human).
Measurements
Confirmed hypoglycaemic events per patient year
0.2 events
liraglutide
Source sentences
Summary
The number of confirmed hypoglycaemic events per patient year was 1·8 for IDegLira, 0·2 for liraglutide, and 2·6 for insulin degludec.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
Report a problemFND-2519052311
08HumanRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, serious adverse events occurred in 2% of patients on IDegLira and 2% on insulin degludec alone.
In plain wordsIn adults with type 2 diabetes, serious side effects occurred in 2% on the combination and 2% on insulin degludec alone.
Peptide
Liraglutide
Outcome
No significant changeSerious adverse events, IDegLira versus insulin degludec
Study
n: not reported in source
Comparator
Insulin degludec
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 26 weeksAs given in this study (human).
Measurements
Serious adverse events
2%
IDegLira
Serious adverse events
2%
insulin degludec
Source sentences
Summary
Serious adverse events occurred in 19 (2%) of 825 patients in the IDegLira group, eight (2%) of 412 in the insulin degludec group
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
Report a problemFND-2519052313

Studies that did not test the peptide alone6

In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Liraglutide.

09HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In insulin-naive adults with type 2 diabetes, the fixed-ratio combination IDegLira lowered HbA1c more than liraglutide alone at 26 weeks.
In plain wordsIn adults with type 2 diabetes, the insulin plus liraglutide combination lowered HbA1c more than liraglutide alone after 26 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change, IDegLira versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.8 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Estimated treatment difference
−0.64%
IDegLira vs liraglutide
Source sentences
Summary
superior to liraglutide (-0·64%, -0·75 to -0·53, p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2519052302
10HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In insulin-naive adults with type 2 diabetes, HbA1c fell by 1.9% to 6.4% with the fixed-ratio combination IDegLira at 26 weeks.
In plain wordsIn adults with type 2 diabetes, HbA1c fell by 1.9% with the insulin plus liraglutide combination after 26 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change with IDegLira
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c decrease
1.9%
IDegLira
Source sentences
Summary
mean HbA1c had decreased by 1·9% (SD 1·1) to 6·4% (1·0) with IDegLira,
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2519052303
11HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, fewer participants on IDegLira than on liraglutide alone reported nausea (8.8% versus 19.7%).
In plain wordsIn adults with type 2 diabetes, nausea was less common with the insulin plus liraglutide combination (8.8%) than with liraglutide alone (19.7%).
Peptide
Liraglutide
Outcome
DecreaseNausea, IDegLira versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.8 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Nausea
8.8%
IDegLira
Nausea
19.7%
liraglutide
Source sentences
Summary
IDegLira was generally well tolerated; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8·8 vs 19·7%), although the insulin degludec group had the fewest participants with gastrointestinal adverse events (nausea 3·6%).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2519052306
12HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, no clinically relevant differences between IDegLira and its components were noted in standard safety assessments.
In plain wordsIn adults with type 2 diabetes, standard safety checks showed no clinically relevant differences between the combination and its single components.
Peptide
Liraglutide
Outcome
No significant changeStandard safety assessments
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
We noted no clinically relevant differences between treatments with respect to standard safety assessments, and the safety profile of IDegLira reflected those of its component parts.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2519052308
13HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, confirmed hypoglycaemic events per patient year were 1.8 with IDegLira and 0.2 with liraglutide alone; the abstract reports no test.
In plain wordsIn adults with type 2 diabetes, low blood sugar events per patient year were 1.8 with the combination and 0.2 with liraglutide alone.
Peptide
Liraglutide
Outcome
IncreaseHypoglycaemic events, IDegLira versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.8 mg
Outcome group
Adverse events · Metabolic and weight
Measurements
Confirmed hypoglycaemic events per patient year
1.8 events
IDegLira
Confirmed hypoglycaemic events per patient year
0.2 events
liraglutide
Source sentences
Summary
The number of confirmed hypoglycaemic events per patient year was 1·8 for IDegLira, 0·2 for liraglutide, and 2·6 for insulin degludec.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2519052310
14HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In insulin-naive adults with type 2 diabetes, serious adverse events occurred in 2% of patients on IDegLira and 3% on liraglutide alone.
In plain wordsIn adults with type 2 diabetes, serious side effects occurred in 2% on the combination and 3% on liraglutide alone.
Peptide
Liraglutide
Outcome
No significant changeSerious adverse events, IDegLira versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.8 mg
Outcome group
Adverse events · Metabolic and weight
Measurements
Serious adverse events
19 patients
IDegLira
Serious adverse events
14 patients
liraglutide
Source sentences
Summary
Serious adverse events occurred in 19 (2%) of 825 patients in the IDegLira group, eight (2%) of 412 in the insulin degludec group, and 14 (3%) of 412 in the liraglutide group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day).
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Report a problemFND-2519052314

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 postedNCT01336023

Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 1,66323 May 2011 to 22 Nov 2012

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 19 Feb 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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