A 1-year safety study of dulaglutide in Japanese patients with type 2 diabetes on a single oral hypoglycemic agent: an open-label, nonrandomized, phase 3 trial.

Emoto M, Terauchi Y, Ozeki A, Oura T, Takeuchi M, Imaoka T

Endocrine journal17 Oct 2015Cited by 26 (Europe PMC)

PMID26477324DOI10.1507/endocrj.ej15-0401PepBankPUB-26477324

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 study17

16 results from studies that gave the peptide. 16 results from people.

01HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes, 92.9% completed dulaglutide treatment.
In plain wordsIn Japanese patients with type 2 diabetes, 92.9% completed dulaglutide treatment.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableTreatment completion
Study
n = 394
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Measurements
Completion
92.9%
52-week treatment
Source sentences
Summary
A total of 394 patients were treated with study drug, and 92.9% completed the 52-week treatment period.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732401
02HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes receiving dulaglutide, nasopharyngitis was among the most frequent adverse events.
In plain wordsIn Japanese patients with type 2 diabetes receiving dulaglutide, nasopharyngitis was a frequent adverse event.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNasopharyngitis
Study
n = 394
Outcome group
Adverse events · Respiratory
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
The most frequent treatment-emergent adverse events were nasopharyngitis and gastrointestinal disorders, including constipation, diarrhea, and nausea.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732402
03HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes receiving dulaglutide, frequent gastrointestinal adverse events included constipation.
In plain wordsIn Japanese patients with type 2 diabetes receiving dulaglutide, constipation was a frequent digestive adverse event.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableConstipation
Study
n = 394
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
The most frequent treatment-emergent adverse events were nasopharyngitis and gastrointestinal disorders, including constipation, diarrhea, and nausea.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732403
04HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes receiving dulaglutide, frequent gastrointestinal adverse events included diarrhea.
In plain wordsIn Japanese patients with type 2 diabetes receiving dulaglutide, diarrhea was a frequent digestive adverse event.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiarrhea
Study
n = 394
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
The most frequent treatment-emergent adverse events were nasopharyngitis and gastrointestinal disorders, including constipation, diarrhea, and nausea.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732404
05HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes receiving dulaglutide, frequent gastrointestinal adverse events included nausea.
In plain wordsIn Japanese patients with type 2 diabetes receiving dulaglutide, nausea was a frequent digestive adverse event.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea
Study
n = 394
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
The most frequent treatment-emergent adverse events were nasopharyngitis and gastrointestinal disorders, including constipation, diarrhea, and nausea.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732405
06HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes receiving dulaglutide, no severe hypoglycemic episodes occurred.
In plain wordsIn Japanese patients with type 2 diabetes receiving dulaglutide, no severe low blood sugar episodes occurred.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableSevere hypoglycemia
Study
n = 394
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycemic episodes occurred during the study.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732407
07HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes, pancreatic amylase increased from baseline across dulaglutide background therapy groups.
In plain wordsIn Japanese patients with type 2 diabetes, pancreatic amylase increased from baseline across dulaglutide background therapy groups.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreasePancreatic amylase
Study
n = 394
Outcome group
Adverse events · Gastrointestinal
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Increases from baseline in pancreatic and total amylase, lipase, and pulse rate were observed in all 5 combination therapy groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732408
08HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes, total amylase increased from baseline across dulaglutide background therapy groups.
In plain wordsIn Japanese patients with type 2 diabetes, total amylase increased from baseline across dulaglutide background therapy groups.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseTotal amylase
Study
n = 394
Outcome group
Adverse events · Gastrointestinal
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Increases from baseline in pancreatic and total amylase, lipase, and pulse rate were observed in all 5 combination therapy groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732409
09HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes, lipase increased from baseline across dulaglutide background therapy groups.
In plain wordsIn Japanese patients with type 2 diabetes, lipase increased from baseline across dulaglutide background therapy groups.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseLipase
Study
n = 394
Outcome group
Adverse events · Gastrointestinal
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Increases from baseline in pancreatic and total amylase, lipase, and pulse rate were observed in all 5 combination therapy groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732410
10HumanNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes, pulse rate increased from baseline across dulaglutide background therapy groups.
In plain wordsIn Japanese patients with type 2 diabetes, pulse rate increased from baseline across dulaglutide background therapy groups.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreasePulse rate
Study
n = 394
Outcome group
Heart function · Cardiovascular
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Increases from baseline in pancreatic and total amylase, lipase, and pulse rate were observed in all 5 combination therapy groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732411
11HumanNon-randomized trialEfficacy outcome
In Japanese patients with type 2 diabetes, HbA1c decreased from baseline across dulaglutide background therapy groups.
In plain wordsIn Japanese patients with type 2 diabetes, HbA1c decreased from baseline across dulaglutide background therapy groups.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c
Study
n = 394
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−1.57 to −1.69%
across background therapy groups
Source sentences
Summary
Significant reductions from baseline in HbA1c were observed in all 5 combination therapy groups (-1.57% to -1.69%, p < 0.001 for all).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732412
12HumanNon-randomized trialEfficacy outcome
In Japanese patients with type 2 diabetes, weight increased from baseline with dulaglutide on thiazolidinedione background therapy.
In plain wordsIn Japanese patients with type 2 diabetes, weight increased from baseline with dulaglutide on thiazolidinedione background therapy.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseWeight with TZD background
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Mean body weight changes from baseline varied across the combination therapy groups: a significant increase was observed in combination with TZD, there were no significant changes in combination with SU or GLN, and significant reductions were observed in combination with BG or AGI.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732413
13HumanNon-randomized trialEfficacy outcome
In Japanese patients with type 2 diabetes, weight did not significantly change with dulaglutide on sulfonylurea background therapy.
In plain wordsIn Japanese patients with type 2 diabetes, weight did not significantly change with dulaglutide on sulfonylurea background therapy.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeWeight with SU background
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Mean body weight changes from baseline varied across the combination therapy groups: a significant increase was observed in combination with TZD, there were no significant changes in combination with SU or GLN, and significant reductions were observed in combination with BG or AGI.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732414
14HumanNon-randomized trialEfficacy outcome
In Japanese patients with type 2 diabetes, weight did not significantly change with dulaglutide on glinide background therapy.
In plain wordsIn Japanese patients with type 2 diabetes, weight did not significantly change with dulaglutide on glinide background therapy.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeWeight with GLN background
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Mean body weight changes from baseline varied across the combination therapy groups: a significant increase was observed in combination with TZD, there were no significant changes in combination with SU or GLN, and significant reductions were observed in combination with BG or AGI.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732415
15HumanNon-randomized trialEfficacy outcome
In Japanese patients with type 2 diabetes, weight decreased from baseline with dulaglutide on biguanide background therapy.
In plain wordsIn Japanese patients with type 2 diabetes, weight decreased from baseline with dulaglutide on biguanide background therapy.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseWeight with BG background
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Mean body weight changes from baseline varied across the combination therapy groups: a significant increase was observed in combination with TZD, there were no significant changes in combination with SU or GLN, and significant reductions were observed in combination with BG or AGI.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732416
16HumanNon-randomized trialEfficacy outcome
In Japanese patients with type 2 diabetes, weight decreased from baseline with dulaglutide on alpha-glucosidase inhibitor background therapy.
In plain wordsIn Japanese patients with type 2 diabetes, weight decreased from baseline with dulaglutide on alpha-glucosidase inhibitor background therapy.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseWeight with AGI background
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Mean body weight changes from baseline varied across the combination therapy groups: a significant increase was observed in combination with TZD, there were no significant changes in combination with SU or GLN, and significant reductions were observed in combination with BG or AGI.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
Report a problemFND-2647732417

Studies that did not test the peptide alone1

In this study, Dulaglutide (Trulicity) 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 Dulaglutide (Trulicity).

17HumanNot a test of Dulaglutide (Trulicity) aloneNon-randomized trialSafety outcome
In Japanese patients with type 2 diabetes, hypoglycemia was more frequent with dulaglutide plus sulfonylureas than other combinations.
In plain wordsIn Japanese patients with type 2 diabetes, low blood sugar was more frequent with dulaglutide plus sulfonylureas than other combinations.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHypoglycemia by oral agent
Study
n: not reported in source
Comparator
dulaglutide with other oral agents
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
Incidences of hypoglycemia varied across the combination therapy groups: incidence was greater in patients receiving SU compared with other combinations.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3, nonrandomized, open-label, parallel-group, 52-week study, safety and efficacy of once weekly dulaglutide 0.75 mg were assessed in Japanese patients with T2D on a single OHA (sulfonylureas [SU], biguanides [BG], α-glucosidase inhibitors [AGI], thiazolidinedione [TZD], or glinides [GLN]).
In this study, Dulaglutide (Trulicity) 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 Dulaglutide (Trulicity).
Report a problemFND-2647732406

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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A 1-year safety study of dulaglutide in Japanese patients with type 2 diabetes on a single oral hypoglycemic agent: an open-label, nonrandomized, phase 3 trial.

Summary

Results from this study17

Studies that did not test the peptide alone1

Version history

Subjects

Publication types

MeSH terms