An Investigative Study of Pancreatic Exocrine Biomarkers, Histology, and Histomorphometry in Male Zucker Diabetic Fatty (ZDF) Rats Given Dulaglutide by Subcutaneous Injection Twice Weekly for 13 Weeks.

Usborne A, Byrd RA, Meehan J, Blackbourne JL, Sullivan J, Poitout-Belissent F, Prefontaine A, Martin JA, Vahle JL

Toxicologic pathology12 Aug 2015Cited by 11 (Europe PMC)

PMID26269615DOI10.1177/0192623315596857PepBankPUB-26269615

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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. No result from this study comes from people.

01AnimalAnimal study (in vivo)Efficacy outcome
In ZDF rats, dulaglutide reduced glucose at all doses.
In plain wordsIn rats, dulaglutide reduced glucose at all tested doses.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseGlucose
Study
ratn: not reported in source
male Zucker diabetic fatty rats
Comparator
vehicle control
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.5, 1.5, and 5.0 mg/kg/dose twice weekly · subcutaneous · 13 weeksAs given in this study (rat).
Source sentences
Summary
Efficacious reductions in glucose and hemoglobin A1c occurred at all dulaglutide doses.
2 context sentences(design, population, supporting numbers)
Summary · context
The effects of dulaglutide were evaluated in male Zucker diabetic fatty (ZDF) rats to examine whether dulaglutide may induce or modulate pancreatitis.
Summary · context
Rats were randomized to dose groups receiving twice-weekly subcutaneously administered dulaglutide 0.5, 1.5, and 5.0 mg/kg/dose (corresponding human plasma exposures following twice-weekly dosing are 3-, 8-, and 30-fold, respectively) for 13 weeks or to vehicle control.
Report a problemFND-2626961501
02AnimalAnimal study (in vivo)Efficacy outcome
In ZDF rats, dulaglutide reduced hemoglobin A1c at all doses.
In plain wordsIn rats, dulaglutide reduced hemoglobin A1c at all tested doses.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHemoglobin A1c
Study
ratn: not reported in source
male Zucker diabetic fatty rats
Comparator
vehicle control
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.5, 1.5, and 5.0 mg/kg/dose twice weekly · subcutaneous · 13 weeksAs given in this study (rat).
Source sentences
Summary
Efficacious reductions in glucose and hemoglobin A1c occurred at all dulaglutide doses.
2 context sentences(design, population, supporting numbers)
Summary · context
The effects of dulaglutide were evaluated in male Zucker diabetic fatty (ZDF) rats to examine whether dulaglutide may induce or modulate pancreatitis.
Summary · context
Rats were randomized to dose groups receiving twice-weekly subcutaneously administered dulaglutide 0.5, 1.5, and 5.0 mg/kg/dose (corresponding human plasma exposures following twice-weekly dosing are 3-, 8-, and 30-fold, respectively) for 13 weeks or to vehicle control.
Report a problemFND-2626961502
03AnimalAnimal study (in vivo)Safety outcome
In ZDF rats, dulaglutide did not affect lipase activity.
In plain wordsIn rats, dulaglutide did not affect lipase activity.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeLipase activity
Study
ratn: not reported in source
male Zucker diabetic fatty rats
Comparator
vehicle control
Outcome group
Adverse events · Gastrointestinal
Studied dose
0.5, 1.5, and 5.0 mg/kg/dose twice weekly · subcutaneous · 13 weeksAs given in this study (rat).
Source sentences
Summary
Lipase activity was unaffected, and there were modest increases in total and pancreatic amylase activities at all doses without individual microscopic inflammatory correlates.
2 context sentences(design, population, supporting numbers)
Summary · context
The effects of dulaglutide were evaluated in male Zucker diabetic fatty (ZDF) rats to examine whether dulaglutide may induce or modulate pancreatitis.
Summary · context
Rats were randomized to dose groups receiving twice-weekly subcutaneously administered dulaglutide 0.5, 1.5, and 5.0 mg/kg/dose (corresponding human plasma exposures following twice-weekly dosing are 3-, 8-, and 30-fold, respectively) for 13 weeks or to vehicle control.
Report a problemFND-2626961503
04AnimalAnimal study (in vivo)Safety outcome
In ZDF rats, dulaglutide modestly increased total amylase at all doses without individual microscopic inflammatory correlates.
In plain wordsIn rats, dulaglutide modestly increased total amylase at all doses without corresponding microscopic inflammation.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseTotal amylase activity
Study
ratn: not reported in source
male Zucker diabetic fatty rats
Comparator
vehicle control
Outcome group
Adverse events · Gastrointestinal
Studied dose
0.5, 1.5, and 5.0 mg/kg/dose twice weekly · subcutaneous · 13 weeksAs given in this study (rat).
Source sentences
Summary
Lipase activity was unaffected, and there were modest increases in total and pancreatic amylase activities at all doses without individual microscopic inflammatory correlates.
2 context sentences(design, population, supporting numbers)
Summary · context
The effects of dulaglutide were evaluated in male Zucker diabetic fatty (ZDF) rats to examine whether dulaglutide may induce or modulate pancreatitis.
Summary · context
Rats were randomized to dose groups receiving twice-weekly subcutaneously administered dulaglutide 0.5, 1.5, and 5.0 mg/kg/dose (corresponding human plasma exposures following twice-weekly dosing are 3-, 8-, and 30-fold, respectively) for 13 weeks or to vehicle control.
Report a problemFND-2626961504
05AnimalAnimal study (in vivo)Safety outcome
In ZDF rats, dulaglutide modestly increased pancreatic amylase at all doses without individual microscopic inflammatory correlates.
In plain wordsIn rats, dulaglutide modestly increased pancreatic amylase at all doses without corresponding microscopic inflammation.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreasePancreatic amylase activity
Study
ratn: not reported in source
male Zucker diabetic fatty rats
Comparator
vehicle control
Outcome group
Adverse events · Gastrointestinal
Studied dose
0.5, 1.5, and 5.0 mg/kg/dose twice weekly · subcutaneous · 13 weeksAs given in this study (rat).
Source sentences
Summary
Lipase activity was unaffected, and there were modest increases in total and pancreatic amylase activities at all doses without individual microscopic inflammatory correlates.
2 context sentences(design, population, supporting numbers)
Summary · context
The effects of dulaglutide were evaluated in male Zucker diabetic fatty (ZDF) rats to examine whether dulaglutide may induce or modulate pancreatitis.
Summary · context
Rats were randomized to dose groups receiving twice-weekly subcutaneously administered dulaglutide 0.5, 1.5, and 5.0 mg/kg/dose (corresponding human plasma exposures following twice-weekly dosing are 3-, 8-, and 30-fold, respectively) for 13 weeks or to vehicle control.
Report a problemFND-2626961505
06AnimalAnimal study (in vivo)Safety outcome
In ZDF rats, dulaglutide increased interlobular ductal epithelium without ductal cell proliferation.
In plain wordsIn rats, dulaglutide increased interlobular ductal epithelium without ductal cell proliferation.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseInterlobular ductal epithelium
Study
ratn: not reported in source
male Zucker diabetic fatty rats
Comparator
vehicle control
Outcome group
Adverse events · Gastrointestinal
Studied dose
≥0.5 mg/kg · subcutaneous · 13 weeksAs given in this study (rat).
Source sentences
Summary
Microscopic dulaglutide-related pancreatic changes included increased interlobular ductal epithelium without ductal cell proliferation (≥0.5 mg/kg)
2 context sentences(design, population, supporting numbers)
Summary · context
The effects of dulaglutide were evaluated in male Zucker diabetic fatty (ZDF) rats to examine whether dulaglutide may induce or modulate pancreatitis.
Summary · context
Rats were randomized to dose groups receiving twice-weekly subcutaneously administered dulaglutide 0.5, 1.5, and 5.0 mg/kg/dose (corresponding human plasma exposures following twice-weekly dosing are 3-, 8-, and 30-fold, respectively) for 13 weeks or to vehicle control.
Report a problemFND-2626961506
07AnimalAnimal study (in vivo)Safety outcome
In ZDF rats, dulaglutide-related ductal epithelial increases occurred without ductal cell proliferation.
In plain wordsIn rats, dulaglutide-related ductal tissue increases occurred without ductal cell proliferation.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeDuctal cell proliferation
Study
ratn: not reported in source
male Zucker diabetic fatty rats
Comparator
vehicle control
Outcome group
Adverse events · Gastrointestinal
Studied dose
≥0.5 mg/kg · subcutaneous · 13 weeksAs given in this study (rat).
Source sentences
Summary
Microscopic dulaglutide-related pancreatic changes included increased interlobular ductal epithelium without ductal cell proliferation (≥0.5 mg/kg)
2 context sentences(design, population, supporting numbers)
Summary · context
The effects of dulaglutide were evaluated in male Zucker diabetic fatty (ZDF) rats to examine whether dulaglutide may induce or modulate pancreatitis.
Summary · context
Rats were randomized to dose groups receiving twice-weekly subcutaneously administered dulaglutide 0.5, 1.5, and 5.0 mg/kg/dose (corresponding human plasma exposures following twice-weekly dosing are 3-, 8-, and 30-fold, respectively) for 13 weeks or to vehicle control.
Report a problemFND-2626961507
08AnimalAnimal study (in vivo)Safety outcome
In ZDF rats, dulaglutide increased acinar atrophy with or without inflammation.
In plain wordsIn rats, dulaglutide increased pancreatic acinar atrophy with or without inflammation.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseAcinar atrophy
Study
ratn: not reported in source
male Zucker diabetic fatty rats
Comparator
vehicle control
Outcome group
Adverse events · Gastrointestinal
Studied dose
≥1.5 mg/kg · subcutaneous · 13 weeksAs given in this study (rat).
Source sentences
Summary
increased acinar atrophy with/without inflammation (≥1.5 mg/kg)
2 context sentences(design, population, supporting numbers)
Summary · context
The effects of dulaglutide were evaluated in male Zucker diabetic fatty (ZDF) rats to examine whether dulaglutide may induce or modulate pancreatitis.
Summary · context
Rats were randomized to dose groups receiving twice-weekly subcutaneously administered dulaglutide 0.5, 1.5, and 5.0 mg/kg/dose (corresponding human plasma exposures following twice-weekly dosing are 3-, 8-, and 30-fold, respectively) for 13 weeks or to vehicle control.
Report a problemFND-2626961508
09AnimalAnimal study (in vivo)Safety outcome
In ZDF rats, dulaglutide increased the incidence and severity of neutrophilic acinar pancreatic inflammation.
In plain wordsIn rats, dulaglutide increased the frequency and severity of neutrophilic pancreatic inflammation.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseNeutrophilic acinar pancreatic inflammation
Study
ratn: not reported in source
male Zucker diabetic fatty rats
Comparator
vehicle control
Outcome group
Adverse events · Gastrointestinal
Studied dose
5.0 mg/kg · subcutaneous · 13 weeksAs given in this study (rat).
Source sentences
Summary
increased incidence/severity of neutrophilic acinar pancreatic inflammation (5.0 mg/kg).
2 context sentences(design, population, supporting numbers)
Summary · context
The effects of dulaglutide were evaluated in male Zucker diabetic fatty (ZDF) rats to examine whether dulaglutide may induce or modulate pancreatitis.
Summary · context
Rats were randomized to dose groups receiving twice-weekly subcutaneously administered dulaglutide 0.5, 1.5, and 5.0 mg/kg/dose (corresponding human plasma exposures following twice-weekly dosing are 3-, 8-, and 30-fold, respectively) for 13 weeks or to vehicle control.
Report a problemFND-2626961509

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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

Terms as the source lists them.

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An Investigative Study of Pancreatic Exocrine Biomarkers, Histology, and Histomorphometry in Male Zucker Diabetic Fatty (ZDF) Rats Given Dulaglutide by Subcutaneous Injection Twice Weekly for 13 Weeks.

Summary

Results from this study9

Version history

Subjects

Publication types

MeSH terms

Keywords