Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.

Chin R, Nagaoka S, Nakasawa H, Tanaka Y, Inagaki N

Journal of diabetes investigation11 Nov 2022Cited by 4 (Europe PMC)

PMID36367417PMCIDPMC9889676DOI10.1111/jdi.13932PepBankPUB-36367417

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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 study14

11 results from studies that gave the peptide. 11 results from people.

01HumanObservational studySafety outcome
In Japanese diabetes patients receiving dulaglutide, 231 patients (7.37%) experienced adverse drug reactions, most frequently in the oldest group.
In plain wordsIn Japanese diabetes patients receiving dulaglutide, 7.37% had drug reactions, with the highest frequency at age ≥75 years.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableAny adverse drug reaction
Study
n = 3,136
Outcome group
Adverse events · Whole body
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Patients with adverse drug reactions
231 patients
overall population
Adverse drug reaction rate
7.37%
overall population
Source sentences
Summary
Overall, 231 patients (7.37%) experienced ≥1 adverse drug reactions, with the highest frequency in the ≥75 years group.
5 context sentences(design, population, supporting numbers)
Summary · context
The analysis population (N = 3,136) included 1,538 (49.04%), 869 (27.71%), and 729 (23.25%) patients aged <65 years, ≥65 to <75 years, and ≥75 years, respectively.
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741701
02HumanObservational studySafety outcome
In Japanese diabetes patients receiving dulaglutide, gastrointestinal disorders occurred in 106 patients (3.38%).
In plain wordsIn Japanese diabetes patients receiving dulaglutide, 3.38% had digestive system drug reactions.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableGastrointestinal adverse drug reactions
Study
n = 3,136
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Patients with gastrointestinal adverse drug reactions
106 patients
overall population
Gastrointestinal adverse drug reaction rate
3.38%
overall population
Source sentences
Summary
The most common adverse drug reactions were gastrointestinal disorders (n = 106; 3.38%).
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741702
03HumanObservational studySafety outcome
In Japanese diabetes patients receiving dulaglutide, severe hypoglycemia occurred in 4 patients (0.13%).
In plain wordsIn Japanese diabetes patients receiving dulaglutide, 0.13% had severely low blood sugar.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableSevere hypoglycemia
Study
n = 3,136
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Patients with severe hypoglycemia
4 patients
overall population
Severe hypoglycemia rate
0.13%
overall population
Source sentences
Summary
Severe hypoglycemia (n = 4; 0.13%), major adverse cardiovascular events (n = 4; 0.13%), and acute pancreatitis (n = 1; 0.03%) were uncommon.
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741703
04HumanObservational studySafety outcome
In Japanese diabetes patients receiving dulaglutide, major adverse cardiovascular events occurred in 4 patients (0.13%).
In plain wordsIn Japanese diabetes patients receiving dulaglutide, 0.13% had major cardiovascular events.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableMajor adverse cardiovascular events
Study
n = 3,136
Outcome group
Adverse events · Cardiovascular
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Patients with major adverse cardiovascular events
4 patients
overall population
Major adverse cardiovascular event rate
0.13%
overall population
Source sentences
Summary
Severe hypoglycemia (n = 4; 0.13%), major adverse cardiovascular events (n = 4; 0.13%), and acute pancreatitis (n = 1; 0.03%) were uncommon.
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741704
05HumanObservational studySafety outcome
In Japanese diabetes patients receiving dulaglutide, acute pancreatitis occurred in 1 patient (0.03%).
In plain wordsIn Japanese diabetes patients receiving dulaglutide, 0.03% had acute pancreatitis.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableAcute pancreatitis
Study
n = 3,136
Outcome group
Adverse events · Gastrointestinal
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Patients with acute pancreatitis
1 patients
overall population
Acute pancreatitis rate
0.03%
overall population
Source sentences
Summary
Severe hypoglycemia (n = 4; 0.13%), major adverse cardiovascular events (n = 4; 0.13%), and acute pancreatitis (n = 1; 0.03%) were uncommon.
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741705
06HumanObservational studyEfficacy outcome
In Japanese diabetes patients receiving dulaglutide, mean HbA1c decreased by 0.76% from baseline using last observation carried forward.
In plain wordsIn Japanese diabetes patients, dulaglutide use was linked to lower HbA1c than baseline.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c change
Study
n = 3,136
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
HbA1c change from baseline
−0.76%
last observation carried forward
Source sentences
Summary
The mean glycated hemoglobin and bodyweight were reduced from baseline by -0.76% and -1.6 kg, respectively (last observation carried forward).
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741706
07HumanObservational studyEfficacy outcome
In Japanese diabetes patients receiving dulaglutide, mean bodyweight decreased by 1.6 kg from baseline using last observation carried forward.
In plain wordsIn Japanese diabetes patients, dulaglutide use was linked to lower weight than baseline.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseBodyweight change
Study
n = 3,136
Comparator
Baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Bodyweight change from baseline
−1.6 kg
last observation carried forward
Source sentences
Summary
The mean glycated hemoglobin and bodyweight were reduced from baseline by -0.76% and -1.6 kg, respectively (last observation carried forward).
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741707
08HumanObservational studyOther
In Japanese diabetes patients, dulaglutide continuation at 36 months was 58.03% overall.
In plain wordsIn Japanese diabetes patients, 58.03% continued dulaglutide at 36 months.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableOverall treatment continuation
Study
n = 3,136
Outcome group
Treatment adherence and retention · Whole body
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Dulaglutide continuation rate
58.03%
overall, 36 months
Source sentences
Summary
The rate of dulaglutide continuation at 36 months was 58.03% overall and 59.43%, 63.13%, and 48.88% in the <65, ≥65 to <75, and ≥75 years groups, respectively.
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741708
09HumanObservational studyOther
In Japanese diabetes patients aged <65 years, dulaglutide continuation at 36 months was 59.43%.
In plain wordsIn Japanese diabetes patients aged <65 years, 59.43% continued dulaglutide at 36 months.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableTreatment continuation below age 65
Study
n = 1,538
Outcome group
Treatment adherence and retention · Whole body
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Dulaglutide continuation rate
59.43%
age <65 years, 36 months
Source sentences
Summary
The rate of dulaglutide continuation at 36 months was 58.03% overall and 59.43%, 63.13%, and 48.88% in the <65, ≥65 to <75, and ≥75 years groups, respectively.
5 context sentences(design, population, supporting numbers)
Summary · context
The analysis population (N = 3,136) included 1,538 (49.04%), 869 (27.71%), and 729 (23.25%) patients aged <65 years, ≥65 to <75 years, and ≥75 years, respectively.
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741709
10HumanObservational studyOther
In Japanese diabetes patients aged ≥65 to <75 years, dulaglutide continuation at 36 months was 63.13%.
In plain wordsIn Japanese diabetes patients aged ≥65 to <75 years, 63.13% continued dulaglutide at 36 months.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableTreatment continuation at age 65 to below 75
Study
n = 869
Outcome group
Treatment adherence and retention · Whole body
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Dulaglutide continuation rate
63.13%
age ≥65 to <75 years, 36 months
Source sentences
Summary
The rate of dulaglutide continuation at 36 months was 58.03% overall and 59.43%, 63.13%, and 48.88% in the <65, ≥65 to <75, and ≥75 years groups, respectively.
5 context sentences(design, population, supporting numbers)
Summary · context
The analysis population (N = 3,136) included 1,538 (49.04%), 869 (27.71%), and 729 (23.25%) patients aged <65 years, ≥65 to <75 years, and ≥75 years, respectively.
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741710
11HumanObservational studyOther
In Japanese diabetes patients aged ≥75 years, dulaglutide continuation at 36 months was 48.88%.
In plain wordsIn Japanese diabetes patients aged ≥75 years, 48.88% continued dulaglutide at 36 months.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableTreatment continuation at age 75 or older
Study
n = 729
Outcome group
Treatment adherence and retention · Whole body
Studied dose
0.75 mg · 36 monthsAs given in this study (human).
Measurements
Dulaglutide continuation rate
48.88%
age ≥75 years, 36 months
Source sentences
Summary
The rate of dulaglutide continuation at 36 months was 58.03% overall and 59.43%, 63.13%, and 48.88% in the <65, ≥65 to <75, and ≥75 years groups, respectively.
5 context sentences(design, population, supporting numbers)
Summary · context
The analysis population (N = 3,136) included 1,538 (49.04%), 869 (27.71%), and 729 (23.25%) patients aged <65 years, ≥65 to <75 years, and ≥75 years, respectively.
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
Report a problemFND-3636741711

Studies that did not test the peptide alone3

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).

12HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In Japanese dulaglutide users, age ≥65 years was linked to more gastrointestinal adverse drug reactions than younger age.
In plain wordsIn Japanese dulaglutide users, age ≥65 years was linked to more digestive system drug reactions than younger age.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseAge association with gastrointestinal reactions
Study
n: not reported in source
Comparator
Age below 65 years
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
A factor analysis showed age ≥65 years was associated with a greater incidence of gastrointestinal adverse drug reactions as well as larger reductions in glycated hemoglobin and bodyweight.
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
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-3636741712
13HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyEfficacy outcome
In Japanese dulaglutide users, age ≥65 years was linked to larger HbA1c reductions than younger age.
In plain wordsIn Japanese dulaglutide users, age ≥65 years was linked to larger blood sugar reductions than younger age.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseAge association with HbA1c reduction
Study
n: not reported in source
Comparator
Age below 65 years
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
A factor analysis showed age ≥65 years was associated with a greater incidence of gastrointestinal adverse drug reactions as well as larger reductions in glycated hemoglobin and bodyweight.
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
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-3636741713
14HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyEfficacy outcome
In Japanese dulaglutide users, age ≥65 years was linked to larger bodyweight reductions than younger age.
In plain wordsIn Japanese dulaglutide users, age ≥65 years was linked to larger weight reductions than younger age.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseAge association with bodyweight reduction
Study
n: not reported in source
Comparator
Age below 65 years
Outcome group
Body weight · Metabolic and weight
Source sentences
Summary
A factor analysis showed age ≥65 years was associated with a greater incidence of gastrointestinal adverse drug reactions as well as larger reductions in glycated hemoglobin and bodyweight.
4 context sentences(design, population, supporting numbers)
Title · context
Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.
Summary · context
This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.
Summary · context
This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan.
Summary · context
Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).
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-3636741714

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, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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MeSH terms

Keywords

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