Superior efficacy with a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with insulin degludec and liraglutide in insulin-naïve Japanese patients with type 2 diabetes in a phase 3, open-label, randomized trial.

Kaku K, Araki E, Tanizawa Y, Ross Agner B, Nishida T, Ranthe M, Inagaki N

Diabetes, obesity & metabolism28 Aug 2019Cited by 23 (Europe PMC)

PMID31407845PMCIDPMC6899795DOI10.1111/dom.13856PepBankPUB-31407845

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. Results still quote short attributed sentences.

Results from this study12

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes uncontrolled on oral drugs, IDegLira lowered HbA1c more than insulin degludec alone over 52 weeks.
In plain wordsIn Japanese adults with type 2 diabetes, insulin plus liraglutide lowered HbA1c more than insulin alone.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change, IDegLira versus degludec
Study
n: not reported in source
Comparator
Insulin degludec
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
IDegLira up to 50 dose steps (50 U degludec/1.8 mg liraglutide) · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−26 mmol/mol
IDegLira
HbA1c change
−20 mmol/mol
degludec
Source sentences
Summary
After 52 weeks, glycated haemoglobin (HbA1c) decreased by 26 mmol/mol with IDegLira vs 20 mmol/mol with degludec and liraglutide
3 context sentences(design, population, supporting numbers)
Summary · context
IDegLira was superior to degludec and liraglutide in terms of HbA1c reduction and superior to degludec in terms of body weight change and rates of hypoglycaemia in Japanese people with T2D.
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
Report a problemFND-3140784501
02HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes uncontrolled on oral drugs, HbA1c decreased by 20 mmol/mol with liraglutide 1.8 mg over 52 weeks.
In plain wordsIn Japanese adults with type 2 diabetes, liraglutide alone lowered HbA1c over 52 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change with liraglutide 1.8 mg
Study
n: not reported in source
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−20 mmol/mol
liraglutide 1.8 mg
Source sentences
Summary
After 52 weeks, glycated haemoglobin (HbA1c) decreased by 26 mmol/mol with IDegLira vs 20 mmol/mol with degludec and liraglutide
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
Report a problemFND-3140784503
03HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, body weight change was 2.9 kg with IDegLira and 4.1 kg with degludec, a significant difference in favour of IDegLira.
In plain wordsIn Japanese adults with type 2 diabetes, weight changed less with insulin plus liraglutide than with insulin alone.
Peptide
Liraglutide
Outcome
DecreaseBody weight change, IDegLira versus degludec
Study
n: not reported in source
Comparator
Insulin degludec
Outcome group
Body weight · Metabolic and weight
Studied dose
IDegLira up to 50 dose steps (50 U degludec/1.8 mg liraglutide) · 52 weeksAs given in this study (human).
Measurements
Body weight change
2.9 kg
IDegLira
Body weight change
4.1 kg
degludec
Source sentences
Summary
Mean body weight changes were 2.9 kg, 4.1 kg and -1.0 kg with IDegLira, degludec and liraglutide, respectively, showing superiority of IDegLira versus degludec (P = .0001), but a significant difference in favour of liraglutide (P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
Report a problemFND-3140784504
04HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, mean body weight changed by -1.0 kg with liraglutide 1.8 mg over 52 weeks.
In plain wordsIn Japanese adults with type 2 diabetes, body weight fell slightly with liraglutide alone over 52 weeks.
Peptide
Liraglutide
Outcome
DecreaseBody weight change with liraglutide 1.8 mg
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
1.8 mg · 52 weeksAs given in this study (human).
Measurements
Body weight change
−1 kg
liraglutide
Source sentences
Summary
Mean body weight changes were 2.9 kg, 4.1 kg and -1.0 kg with IDegLira, degludec and liraglutide, respectively, showing superiority of IDegLira versus degludec (P = .0001), but a significant difference in favour of liraglutide (P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
Report a problemFND-3140784506
05HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, severe or confirmed hypoglycaemia was less frequent with IDegLira than with degludec (rate ratio 0.48).
In plain wordsIn Japanese adults with type 2 diabetes, low blood sugar events were less frequent with insulin plus liraglutide than with insulin alone.
Peptide
Liraglutide
Outcome
DecreaseSevere or blood glucose-confirmed hypoglycaemia, IDegLira versus degludec
Study
n: not reported in source
Comparator
Insulin degludec
Outcome group
Adverse events · Metabolic and weight
Studied dose
IDegLira up to 50 dose steps (50 U degludec/1.8 mg liraglutide) · 52 weeksAs given in this study (human).
Measurements
Rate ratio
0.48 rate ratio
IDegLira vs degludec
Source sentences
Summary
Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira were lower versus degludec (rate ratio 0.48 [95% CI 0.35; 0.68]; P < .0001)
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
Report a problemFND-3140784507
06HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, mean daily total insulin dose was lower with IDegLira than with degludec.
In plain wordsIn Japanese adults with type 2 diabetes, people on insulin plus liraglutide needed less insulin per day than people on insulin alone.
Peptide
Liraglutide
Outcome
DecreaseMean daily total insulin dose, IDegLira versus degludec
Study
n: not reported in source
Comparator
Insulin degludec
Outcome group
Glycemic control · Metabolic and weight
Studied dose
IDegLira up to 50 dose steps (50 U degludec/1.8 mg liraglutide) · 52 weeksAs given in this study (human).
Measurements
Mean daily total insulin dose
27.7 U
IDegLira
Mean daily total insulin dose
34.8 U
degludec
Source sentences
Summary
Mean daily total insulin dose was lower with IDegLira (27.7 U) versus degludec (34.8 U; P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
Report a problemFND-3140784509
07HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, 41.8% of liraglutide-treated participants experienced gastrointestinal adverse events.
In plain wordsIn Japanese adults with type 2 diabetes, over a third of people on liraglutide had stomach or gut side effects.
Peptide
Liraglutide
Outcome
Not applicableGastrointestinal adverse events with liraglutide 1.8 mg
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.8 mg · 52 weeksAs given in this study (human).
Measurements
Participants with gastrointestinal AEs
41.8%
liraglutide
Source sentences
Summary
In total, 34.9%, 22.9% and 41.8% of IDegLira-, degludec- and liraglutide-treated participants experienced gastrointestinal AEs.
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
Report a problemFND-3140784512

Studies that did not test the peptide alone5

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.

08HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes uncontrolled on oral drugs, IDegLira lowered HbA1c more than liraglutide alone over 52 weeks.
In plain wordsIn Japanese adults with type 2 diabetes, insulin plus liraglutide lowered HbA1c more than liraglutide alone.
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
Source sentences
Summary
After 52 weeks, glycated haemoglobin (HbA1c) decreased by 26 mmol/mol with IDegLira vs 20 mmol/mol with degludec and liraglutide
3 context sentences(design, population, supporting numbers)
Summary · context
confirming non-inferiority of IDegLira to degludec and superiority of IDegLira to liraglutide
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
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-3140784502
09HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, overall adverse event rates were similar across IDegLira, degludec and liraglutide.
In plain wordsIn Japanese adults with type 2 diabetes, overall side effect rates were similar across the three treatments.
Peptide
Liraglutide
Outcome
No significant changeOverall adverse event rates
Study
n = 819
Comparator
Insulin degludec and liraglutide 1.8 mg
Outcome group
Adverse events · Whole body
Source sentences
Summary
Overall adverse event (AE) rates were similar.
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
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-3140784510
10HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, body weight change was 2.9 kg with IDegLira and -1.0 kg with liraglutide, a significant difference in favour of liraglutide.
In plain wordsIn Japanese adults with type 2 diabetes, weight went up with insulin plus liraglutide and down with liraglutide alone.
Peptide
Liraglutide
Outcome
IncreaseBody weight change, IDegLira versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.8 mg
Outcome group
Body weight · Metabolic and weight
Measurements
Body weight change
2.9 kg
IDegLira
Body weight change
−1 kg
liraglutide
Source sentences
Summary
Mean body weight changes were 2.9 kg, 4.1 kg and -1.0 kg with IDegLira, degludec and liraglutide, respectively, showing superiority of IDegLira versus degludec (P = .0001), but a significant difference in favour of liraglutide (P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
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-3140784505
11HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, severe or confirmed hypoglycaemia was more frequent with IDegLira than with liraglutide (rate ratio 37.58).
In plain wordsIn Japanese adults with type 2 diabetes, low blood sugar events were more frequent with insulin plus liraglutide than with liraglutide alone.
Peptide
Liraglutide
Outcome
IncreaseSevere or blood glucose-confirmed hypoglycaemia, IDegLira versus liraglutide
Study
n: not reported in source
Comparator
Liraglutide 1.8 mg
Outcome group
Adverse events · Metabolic and weight
Measurements
Rate ratio
37.58 rate ratio
IDegLira vs liraglutide
Source sentences
Summary
but higher versus liraglutide (rate ratio 37.58 [95% CI 19.80; 71.31]; P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
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-3140784508
12HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, 34.9% of IDegLira-treated participants experienced gastrointestinal adverse events.
In plain wordsIn Japanese adults with type 2 diabetes, more than a third of people on insulin plus liraglutide had stomach or gut side effects.
Peptide
Liraglutide
Outcome
Not applicableGastrointestinal adverse events with IDegLira
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Participants with gastrointestinal AEs
34.9%
IDegLira
Source sentences
Summary
In total, 34.9%, 22.9% and 41.8% of IDegLira-, degludec- and liraglutide-treated participants experienced gastrointestinal AEs.
2 context sentences(design, population, supporting numbers)
Summary · context
This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD.
Summary · context
The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
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-3140784511

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 postedNCT02607306

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.

Novo Nordisk A/Sn = 81918 Nov 2015 to 22 Dec 2017

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 9 Apr 2021

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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