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Study · Non-randomized trial · n = 4,006 · 2017

7 results

Assessment of Pancreas Safety in the Development Program of Once-Weekly GLP-1 Receptor Agonist Dulaglutide.

Nauck MA, Frossard JL, Barkin JS, Anglin G, Hensley IE, Harper KD, Milicevic Z

Diabetes care10 Mar 2017Cited by 31 (Europe PMC)

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 study7

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In pooled T2DM trials, 108 dulaglutide-treated patients had events that underwent adjudication.

    In plain wordsIn pooled diabetes trials, 108 dulaglutide-treated patients had events reviewed by adjudicators.

    Outcome
    Not applicablePatients with events undergoing adjudication
    Study

    n = 4,006

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    0.1-3.0 mg · up to 104 weeksAs given in this study (human).

    Measurements

    Patients with adjudicated events
    108 patients
    dulaglutide group
    Patients with adjudicated events
    43 patients
    comparator group including placebo

    Source sentences

    Summary
    Overall, 203 events from 151 patients underwent adjudication (dulaglutide group n = 108; comparator group including placebo n = 43).
  2. 02HumanNon-randomized trialSafety outcome

    In pooled T2DM trials, adjudicators confirmed acute pancreatitis in three dulaglutide-treated patients.

    In plain wordsIn pooled diabetes trials, adjudicators confirmed pancreatitis in three dulaglutide-treated patients.

    Outcome
    Not applicableConfirmed acute pancreatitis
    Study

    n = 4,006

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    0.1-3.0 mg · up to 104 weeksAs given in this study (human).

    Measurements

    Confirmed acute pancreatitis
    3 patients
    dulaglutide
    Confirmed acute pancreatitis
    1 patients
    placebo
    Confirmed acute pancreatitis
    3 patients
    sitagliptin

    Source sentences

    Summary
    Acute pancreatitis was confirmed by adjudication in seven patients (dulaglutide n = 3, placebo n = 1, sitagliptin n = 3).
  3. 03HumanNon-randomized trialSafety outcome

    In pooled T2DM trials, the exposure-adjusted incidence of acute pancreatitis was 0.85 per 1,000 patient-years with dulaglutide and 3.52 with placebo, which the authors describe as similar.

    In plain wordsIn pooled diabetes trials, the pancreatitis rate with dulaglutide was reported as similar to the rate with placebo.

    Outcome
    No significant changeAcute pancreatitis rate versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    0.1-3.0 mg · up to 104 weeksAs given in this study (human).

    Measurements

    Acute pancreatitis exposure-adjusted incidence
    0.85 patients/1,000 patient-years
    dulaglutide group
    Acute pancreatitis exposure-adjusted incidence
    3.52 patients/1,000 patient-years
    placebo group

    Source sentences

    Summary
    Exposure-adjusted incidence rates were as follows: dulaglutide group 0.85 patients/1,000 patient-years, placebo group 3.52 patients/1,000 patient-years, sitagliptin group 4.71 patients/1,000 patient-years.
    Summary
    The exposure-adjusted incidence rate of acute pancreatitis in dulaglutide-treated patients was similar to the rates with placebo, with few reported cases during the entire program.
  4. 04HumanNon-randomized trialSafety outcome

    In pooled T2DM trials, pancreatitis rates were 0.85 with dulaglutide versus 4.71 with sitagliptin per 1,000 patient-years.

    In plain wordsIn pooled diabetes trials, the reported pancreatitis rate was lower with dulaglutide than sitagliptin.

    Outcome
    DecreaseAcute pancreatitis rate versus sitagliptin
    Study

    n: not reported in source

    Comparator
    Sitagliptin
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    0.1-3.0 mg · up to 104 weeksAs given in this study (human).

    Measurements

    Acute pancreatitis exposure-adjusted incidence
    0.85 patients/1,000 patient-years
    dulaglutide group
    Acute pancreatitis exposure-adjusted incidence
    4.71 patients/1,000 patient-years
    sitagliptin group

    Source sentences

    Summary
    Exposure-adjusted incidence rates were as follows: dulaglutide group 0.85 patients/1,000 patient-years, placebo group 3.52 patients/1,000 patient-years, sitagliptin group 4.71 patients/1,000 patient-years.

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).

  1. 05HumanNot a test of Dulaglutide (Trulicity) aloneNon-randomized trialSafety outcome

    In pooled T2DM trials, median lipase increased within the normal range with all treatments except glargine, including dulaglutide.

    In plain wordsLipase increased within normal limits with dulaglutide and other treatments except glargine in pooled diabetes trials.

    Outcome
    IncreaseMedian lipase
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal

    Source sentences

    Summary
    Increases in median values of lipase and pancreatic amylase within the normal range were observed with all treatments except glargine.

    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).

  2. 06HumanNot a test of Dulaglutide (Trulicity) aloneNon-randomized trialSafety outcome

    In pooled T2DM trials, median pancreatic amylase increased within the normal range with all treatments except glargine, including dulaglutide.

    In plain wordsPancreatic amylase increased within normal limits with dulaglutide and other treatments except glargine in pooled diabetes trials.

    Outcome
    IncreaseMedian pancreatic amylase
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal

    Source sentences

    Summary
    Increases in median values of lipase and pancreatic amylase within the normal range were observed with all treatments except glargine.

    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).

  3. 07HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome

    In pooled T2DM trials including dulaglutide, pancreatic enzyme changes were not associated with adverse events.

    In plain wordsIn pooled diabetes trials including dulaglutide, enzyme changes were not linked to adverse events.

    Outcome
    No significant changeAdverse events associated with enzyme changes
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal

    Source sentences

    Summary
    These changes were not associated with AEs.
    1 context sentence
    Summary · context
    Increases in median values of lipase and pancreatic amylase within the normal range were observed with all treatments except glargine.

    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).

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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. 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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