Gastrointestinal Tolerability of Once-Weekly Dulaglutide 3.0 mg and 4.5 mg: A Post Hoc Analysis of the Incidence and Prevalence of Nausea, Vomiting, and Diarrhea in AWARD-11.

Van J, Frias JP, Bonora E, Raha S, Meyer J, Jung H, Cox D, Konig M, Peleshok J, Bethel MA

Diabetes therapy : research, treatment and education of diabetes and related disorders12 Sept 2021Cited by 15 (Europe PMC)

PMID34514554PMCIDPMC8479017DOI10.1007/s13300-021-01140-9PepBankPUB-34514554

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Summary

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Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, early nausea incidence after dulaglutide initiation was at most 8%.
In plain wordsEarly nausea affected at most 8% of patients after dulaglutide initiation.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableEarly nausea incidence
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mgAs given in this study (human).
Measurements
Nausea incidence
≤ 8%
soon after initiation of dulaglutide at 0.75 mg
Source sentences
Summary
The highest incidences of nausea (≤ 8%), vomiting (≤ 2%), and diarrhea (≤ 4%) were primarily observed soon after the initiation of dulaglutide treatment at 0.75 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455401
02HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, early vomiting incidence after dulaglutide initiation was at most 2%.
In plain wordsEarly vomiting affected at most 2% of patients after dulaglutide initiation.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableEarly vomiting incidence
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mgAs given in this study (human).
Measurements
Vomiting incidence
≤ 2%
soon after initiation of dulaglutide at 0.75 mg
Source sentences
Summary
The highest incidences of nausea (≤ 8%), vomiting (≤ 2%), and diarrhea (≤ 4%) were primarily observed soon after the initiation of dulaglutide treatment at 0.75 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455402
03HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, early diarrhea incidence after dulaglutide initiation was at most 4%.
In plain wordsEarly diarrhea affected at most 4% of patients after dulaglutide initiation.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableEarly diarrhea incidence
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.75 mgAs given in this study (human).
Measurements
Diarrhea incidence
≤ 4%
soon after initiation of dulaglutide at 0.75 mg
Source sentences
Summary
The highest incidences of nausea (≤ 8%), vomiting (≤ 2%), and diarrhea (≤ 4%) were primarily observed soon after the initiation of dulaglutide treatment at 0.75 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455403
04HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, nausea incidence declined after initiation despite dulaglutide dose escalation.
In plain wordsNausea became less frequent after initiation despite dulaglutide dose increases.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseNausea incidence over time
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
escalated to 1.5, 3.0 and 4.5 mg once weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Incidence then declined throughout the remainder of the study, even with dose escalation to 1.5, 3.0, and 4.5 mg.
3 context sentences(design, population, supporting numbers)
Summary · context
The highest incidences of nausea (≤ 8%), vomiting (≤ 2%), and diarrhea (≤ 4%) were primarily observed soon after the initiation of dulaglutide treatment at 0.75 mg.
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455404
05HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, vomiting incidence declined after initiation despite dulaglutide dose escalation.
In plain wordsVomiting became less frequent after initiation despite dulaglutide dose increases.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseVomiting incidence over time
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
escalated to 1.5, 3.0 and 4.5 mg once weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Incidence then declined throughout the remainder of the study, even with dose escalation to 1.5, 3.0, and 4.5 mg.
3 context sentences(design, population, supporting numbers)
Summary · context
The highest incidences of nausea (≤ 8%), vomiting (≤ 2%), and diarrhea (≤ 4%) were primarily observed soon after the initiation of dulaglutide treatment at 0.75 mg.
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455405
06HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, diarrhea incidence declined after initiation despite dulaglutide dose escalation.
In plain wordsDiarrhea became less frequent after initiation despite dulaglutide dose increases.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseDiarrhea incidence over time
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
escalated to 1.5, 3.0 and 4.5 mg once weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Incidence then declined throughout the remainder of the study, even with dose escalation to 1.5, 3.0, and 4.5 mg.
3 context sentences(design, population, supporting numbers)
Summary · context
The highest incidences of nausea (≤ 8%), vomiting (≤ 2%), and diarrhea (≤ 4%) were primarily observed soon after the initiation of dulaglutide treatment at 0.75 mg.
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455406
07HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, severe nausea during dulaglutide treatment occurred in at most 0.6%.
In plain wordsSevere nausea affected at most 0.6% of patients receiving dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableSevere nausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
Severe nausea incidence
≤ 0.6%
patients, through 52 weeks
Source sentences
Summary
Most of these GI TEAEs were mild to moderate in severity, with severe nausea, vomiting, or diarrhea events occurring in ≤ 0.6% of patients.
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455407
08HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, severe vomiting during dulaglutide treatment occurred in at most 0.6%.
In plain wordsSevere vomiting affected at most 0.6% of patients receiving dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableSevere vomiting
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
Severe vomiting incidence
≤ 0.6%
patients, through 52 weeks
Source sentences
Summary
Most of these GI TEAEs were mild to moderate in severity, with severe nausea, vomiting, or diarrhea events occurring in ≤ 0.6% of patients.
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455408
09HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, severe diarrhea during dulaglutide treatment occurred in at most 0.6%.
In plain wordsSevere diarrhea affected at most 0.6% of patients receiving dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableSevere diarrhea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
Severe diarrhea incidence
≤ 0.6%
patients, through 52 weeks
Source sentences
Summary
Most of these GI TEAEs were mild to moderate in severity, with severe nausea, vomiting, or diarrhea events occurring in ≤ 0.6% of patients.
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455409
10HumanRandomized controlled trialSafety outcome
In AWARD-11 patients, discontinuation due to nausea with dulaglutide was at most 1.5% across treatment groups.
In plain wordsAt most 1.5% of patients stopped dulaglutide because of nausea across treatment groups.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiscontinuation due to nausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
Discontinuation due to nausea
≤ 1.5%
across treatment groups
Source sentences
Summary
Treatment discontinuation due to nausea was low across treatment groups (≤ 1.5%).
2 context sentences(design, population, supporting numbers)
Summary · context
The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks.
Summary · context
Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached.
Report a problemFND-3451455410

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Version history

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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

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