Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial.

Kiyosue A, Seino Y, Nishijima K, Bosch-Traberg H, Kaku K

Journal of diabetes investigation24 Nov 2017Cited by 5 (Europe PMC)

PMID28984041PMCIDPMC6031500DOI10.1111/jdi.12759PepBankPUB-28984041

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 study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes on an alpha-glucosidase inhibitor, adverse event rates were comparable with liraglutide (74.6%) and an additional OAD (70.0%).
In plain wordsIn Japanese adults with type 2 diabetes on an alpha-glucosidase inhibitor, liraglutide and an extra pill had similar adverse event rates.
Peptide
Liraglutide
Outcome
No significant changeAdverse events with alpha-glucosidase inhibitor background
Study
n: not reported in source
Comparator
Additional OAD
Analysis
Primary
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.9 mg/day · 52 weeksAs given in this study (human).
Measurements
Adverse event proportion
74.6%
liraglutide, alpha-glucosidase inhibitor
Source sentences
Summary
The proportions of patients experiencing adverse events across the different groups of pretrial OADs were comparable between liraglutide and additional OAD (α-glucosidase inhibitor 74.6 vs 70.0%; glinide 93.1 vs 87.1%; metformin 91.8 vs 87.1%; thiazolidinedione 86.2 vs 96.4%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome investigated in this post-hoc analysis was the incidence of adverse events.
Summary · context
patients with type 2 diabetes inadequately controlled with a single OAD (α-glucosidase inhibitor, glinide, metformin or thiazolidinedione) were randomized to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group) or pretrial OAD in combination with an additional OAD (additional OAD group).
Report a problemFND-2898404101
02HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes on a glinide, adverse event rates were comparable with liraglutide (93.1%) and an additional OAD (87.1%).
In plain wordsIn Japanese adults with type 2 diabetes on a glinide, liraglutide and an extra pill had similar adverse event rates.
Peptide
Liraglutide
Outcome
No significant changeAdverse events with glinide background
Study
n: not reported in source
Comparator
Additional OAD
Analysis
Primary
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.9 mg/day · 52 weeksAs given in this study (human).
Measurements
Adverse event proportion
93.1%
liraglutide, glinide
Source sentences
Summary
The proportions of patients experiencing adverse events across the different groups of pretrial OADs were comparable between liraglutide and additional OAD (α-glucosidase inhibitor 74.6 vs 70.0%; glinide 93.1 vs 87.1%; metformin 91.8 vs 87.1%; thiazolidinedione 86.2 vs 96.4%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome investigated in this post-hoc analysis was the incidence of adverse events.
Summary · context
patients with type 2 diabetes inadequately controlled with a single OAD (α-glucosidase inhibitor, glinide, metformin or thiazolidinedione) were randomized to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group) or pretrial OAD in combination with an additional OAD (additional OAD group).
Report a problemFND-2898404102
03HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes on metformin, adverse event rates were comparable with liraglutide (91.8%) and an additional OAD (87.1%).
In plain wordsIn Japanese adults with type 2 diabetes on metformin, liraglutide and an extra pill had similar adverse event rates.
Peptide
Liraglutide
Outcome
No significant changeAdverse events with metformin background
Study
n: not reported in source
Comparator
Additional OAD
Analysis
Primary
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.9 mg/day · 52 weeksAs given in this study (human).
Measurements
Adverse event proportion
91.8%
liraglutide, metformin
Source sentences
Summary
The proportions of patients experiencing adverse events across the different groups of pretrial OADs were comparable between liraglutide and additional OAD (α-glucosidase inhibitor 74.6 vs 70.0%; glinide 93.1 vs 87.1%; metformin 91.8 vs 87.1%; thiazolidinedione 86.2 vs 96.4%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome investigated in this post-hoc analysis was the incidence of adverse events.
Summary · context
patients with type 2 diabetes inadequately controlled with a single OAD (α-glucosidase inhibitor, glinide, metformin or thiazolidinedione) were randomized to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group) or pretrial OAD in combination with an additional OAD (additional OAD group).
Report a problemFND-2898404103
04HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes on a thiazolidinedione, adverse event rates were comparable with liraglutide (86.2%) and an additional OAD (96.4%).
In plain wordsIn Japanese adults with type 2 diabetes on a thiazolidinedione, liraglutide and an extra pill had similar adverse event rates.
Peptide
Liraglutide
Outcome
No significant changeAdverse events with thiazolidinedione background
Study
n: not reported in source
Comparator
Additional OAD
Analysis
Primary
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.9 mg/day · 52 weeksAs given in this study (human).
Measurements
Adverse event proportion
86.2%
liraglutide, thiazolidinedione
Source sentences
Summary
The proportions of patients experiencing adverse events across the different groups of pretrial OADs were comparable between liraglutide and additional OAD (α-glucosidase inhibitor 74.6 vs 70.0%; glinide 93.1 vs 87.1%; metformin 91.8 vs 87.1%; thiazolidinedione 86.2 vs 96.4%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome investigated in this post-hoc analysis was the incidence of adverse events.
Summary · context
patients with type 2 diabetes inadequately controlled with a single OAD (α-glucosidase inhibitor, glinide, metformin or thiazolidinedione) were randomized to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group) or pretrial OAD in combination with an additional OAD (additional OAD group).
Report a problemFND-2898404104
05HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, minor hypoglycemia was infrequent with liraglutide (seven episodes in two patients) and with an additional OAD (two episodes in two patients).
In plain wordsIn Japanese adults with type 2 diabetes, mild low blood sugar was rare with liraglutide and with an extra pill.
Peptide
Liraglutide
Outcome
Not applicableMinor hypoglycemia
Study
n: not reported in source
Comparator
Additional OAD
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.9 mg/day · 52 weeksAs given in this study (human).
Source sentences
Summary
Minor hypoglycemia was infrequent (seven episodes in two patients randomized to liraglutide, and two episodes in two patients randomized to additional OAD).
1 context sentence(design, population, supporting numbers)
Summary · context
patients with type 2 diabetes inadequately controlled with a single OAD (α-glucosidase inhibitor, glinide, metformin or thiazolidinedione) were randomized to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group) or pretrial OAD in combination with an additional OAD (additional OAD group).
Report a problemFND-2898404105
06HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, the mean HbA1c reduction appeared greater with liraglutide than with an additional OAD, with treatment differences from -0.14% to -0.44% across OAD classes.
In plain wordsIn Japanese adults with type 2 diabetes, HbA1c appeared to fall more with liraglutide than with an extra pill, depending on the pill class.
Peptide
Liraglutide
Outcome
DecreaseHbA1c treatment difference versus additional OAD
Study
n: not reported in source
Comparator
Additional OAD
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.9 mg/day · 52 weeksAs given in this study (human).
Measurements
HbA1c treatment difference, smallest
−0.14%
liraglutide vs additional OAD
HbA1c treatment difference, largest
−0.44%
liraglutide vs additional OAD
Source sentences
Summary
The mean reduction in glycated hemoglobin appeared greater with liraglutide therapy, with the estimated mean treatment difference (95% confidence interval [CI]) for liraglutide vs additional OAD ranging from -0.14%, 95% CI: -0.48 to 0.21 (-1.5 mmol/mol, 95 CI: -5.2 to 2.3) to -0.44%, 95% CI:-0.79 to…
1 context sentence(design, population, supporting numbers)
Summary · context
patients with type 2 diabetes inadequately controlled with a single OAD (α-glucosidase inhibitor, glinide, metformin or thiazolidinedione) were randomized to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group) or pretrial OAD in combination with an additional OAD (additional OAD group).
Report a problemFND-2898404106

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 postedNCT01512108

Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

Novo Nordisk A/Sn = 36310 Jan 2012 to 26 Apr 2013

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 18 Dec 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

Subjects

Terms as the source lists them.

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