Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type 2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials.

Guo L, Zhang B, Hou J, Zhou Z

Diabetes therapy : research, treatment and education of diabetes and related disorders4 Jul 2020Cited by 5 (Europe PMC)

PMID32621083PMCIDPMC7376772DOI10.1007/s13300-020-00869-zPepBankPUB-32621083

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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. Results still quote short attributed sentences.

Results from this study11

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

01HumanObservational studySafety outcome
In Chinese patients with diabetes, 225 patients receiving dulaglutide reported gastrointestinal treatment-emergent adverse events.
In plain wordsAmong Chinese patients with diabetes receiving dulaglutide, 225 reported digestive adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableAny gastrointestinal TEAE
Study
n = 787
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Patients with GI TEAEs
225 patients
dulaglutide
GI TEAE incidence
28.6%
dulaglutide
Source sentences
Summary
Up to week 26, 225 patients (28.6%) reported at least one GI treatment-emergent adverse event (TEAE).
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108301
02HumanObservational studySafety outcome
In Chinese patients with diabetes receiving dulaglutide, diarrhea occurred in 13.1%; most cases were mild to moderate.
In plain wordsAmong Chinese patients receiving dulaglutide, diarrhea occurred in 13.1%; most cases were mild to moderate.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiarrhea incidence and severity
Study
n = 787
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Diarrhea incidence
13.1%
dulaglutide
Mild-to-moderate diarrhea
92%
diarrhea events
Source sentences
Summary
The most frequently reported GI TEAEs were diarrhea (13.1%), nausea (6.6%), abdominal distension (6.4%), and vomiting (3.0%), with most being categorized as mild to moderate in severity in proportions of 92%, 88%, 94%, and 83%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108302
03HumanObservational studySafety outcome
In Chinese patients with diabetes receiving dulaglutide, nausea occurred in 6.6%; most cases were mild to moderate.
In plain wordsAmong Chinese patients receiving dulaglutide, nausea occurred in 6.6%; most cases were mild to moderate.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea incidence and severity
Study
n = 787
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Nausea incidence
6.6%
dulaglutide
Mild-to-moderate nausea
88%
nausea events
Source sentences
Summary
The most frequently reported GI TEAEs were diarrhea (13.1%), nausea (6.6%), abdominal distension (6.4%), and vomiting (3.0%), with most being categorized as mild to moderate in severity in proportions of 92%, 88%, 94%, and 83%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108303
04HumanObservational studySafety outcome
In Chinese patients with diabetes receiving dulaglutide, abdominal distension occurred in 6.4%; most cases were mild to moderate.
In plain wordsAmong Chinese patients receiving dulaglutide, abdominal swelling occurred in 6.4%; most cases were mild to moderate.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableAbdominal distension incidence and severity
Study
n = 787
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Abdominal distension incidence
6.4%
dulaglutide
Mild-to-moderate abdominal distension
94%
abdominal distension events
Source sentences
Summary
The most frequently reported GI TEAEs were diarrhea (13.1%), nausea (6.6%), abdominal distension (6.4%), and vomiting (3.0%), with most being categorized as mild to moderate in severity in proportions of 92%, 88%, 94%, and 83%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108304
05HumanObservational studySafety outcome
In Chinese patients with diabetes receiving dulaglutide, vomiting occurred in 3.0%; most cases were mild to moderate.
In plain wordsAmong Chinese patients receiving dulaglutide, vomiting occurred in 3.0%; most cases were mild to moderate.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableVomiting incidence and severity
Study
n = 787
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Vomiting incidence
3%
dulaglutide
Mild-to-moderate vomiting
83%
vomiting events
Source sentences
Summary
The most frequently reported GI TEAEs were diarrhea (13.1%), nausea (6.6%), abdominal distension (6.4%), and vomiting (3.0%), with most being categorized as mild to moderate in severity in proportions of 92%, 88%, 94%, and 83%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108305
06HumanObservational studySafety outcome
In Chinese patients with diabetes, gastrointestinal adverse events led 12 patients to discontinue dulaglutide.
In plain wordsAmong Chinese patients with diabetes, 12 stopped dulaglutide because of digestive adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiscontinuation due to gastrointestinal TEAEs
Study
n = 787
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Discontinuations
12 patients
GI TEAEs
Discontinuation rate
1.5%
GI TEAEs
Source sentences
Summary
A total of 12 patients (1.5%) discontinued the dulaglutide treatment as a result of GI TEAEs.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108306
07HumanObservational studySafety outcome
In Chinese patients receiving dulaglutide, gastrointestinal adverse event incidence declined after the first 2 weeks and remained low through week 26.
In plain wordsAmong Chinese patients receiving dulaglutide, digestive adverse events became less frequent after the first 2 weeks.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseGastrointestinal TEAE time course
Study
n = 787
Comparator
First 2 weeks of treatment
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Source sentences
Summary
The incidence of GI TEAEs was more frequent during the first 2 weeks of dulaglutide treatment; however, the incidence declined rapidly after 2 weeks and remained low until week 26.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108311
08HumanObservational studySafety outcome
In Chinese patients receiving dulaglutide, the first diarrhea episode lasted a median of 4.0 days.
In plain wordsAmong Chinese patients receiving dulaglutide, the first diarrhea episode lasted a median of 4.0 days.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableFirst diarrhea episode duration
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Median duration
4 days
first diarrhea episode
Source sentences
Summary
The median duration of the first reported GI TEAEs was 4.0, 5.0, 12.5, and 4.0 days for diarrhea, nausea, abdominal distension, and vomiting, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108307
09HumanObservational studySafety outcome
In Chinese patients receiving dulaglutide, the first nausea episode lasted a median of 5.0 days.
In plain wordsAmong Chinese patients receiving dulaglutide, the first nausea episode lasted a median of 5.0 days.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableFirst nausea episode duration
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Median duration
5 days
first nausea episode
Source sentences
Summary
The median duration of the first reported GI TEAEs was 4.0, 5.0, 12.5, and 4.0 days for diarrhea, nausea, abdominal distension, and vomiting, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108308
10HumanObservational studySafety outcome
In Chinese patients receiving dulaglutide, the first abdominal distension episode lasted a median of 12.5 days.
In plain wordsAmong Chinese patients receiving dulaglutide, the first abdominal swelling episode lasted a median of 12.5 days.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableFirst abdominal distension episode duration
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Median duration
12.5 days
first abdominal distension episode
Source sentences
Summary
The median duration of the first reported GI TEAEs was 4.0, 5.0, 12.5, and 4.0 days for diarrhea, nausea, abdominal distension, and vomiting, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108309
11HumanObservational studySafety outcome
In Chinese patients receiving dulaglutide, the first vomiting episode lasted a median of 4.0 days.
In plain wordsAmong Chinese patients receiving dulaglutide, the first vomiting episode lasted a median of 4.0 days.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableFirst vomiting episode duration
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 or 1.5 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Median duration
4 days
first vomiting episode
Source sentences
Summary
The median duration of the first reported GI TEAEs was 4.0, 5.0, 12.5, and 4.0 days for diarrhea, nausea, abdominal distension, and vomiting, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included.
Summary · context
The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.
Report a problemFND-3262108310

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

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01644500

A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus

Eli Lilly and Companyn = 737Jul 2012 to Aug 2014

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 18 Sept 2019

CompletedPhase 3Results postedNCT01648582

A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

Eli Lilly and Companyn = 774Jul 2012 to Dec 2014

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 18 Sept 2019

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

Subjects

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