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Study · Randomized controlled trial · n = 5,256 · 2020

7 results

OR30-06 Assessment of Dulaglutide Safety in Older Patient Populations in Rewind

Konig M, Gerstein H, Lakshmanan M, Xavier D, Atisso C, Allen S, Cushman W, Leiter L, Raubenheimer P, Franek E

Journal of the Endocrine Society8 May 2020

PMCIDPMC7207332 (opens in a new tab)PepBankPUB-99493867
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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 study7

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

  1. 01HumanRandomized controlled trialSafety outcome

    In REWIND patients aged ≥65 years, composite safety incidence was 15.2% with dulaglutide versus 16.1% with placebo.

    In plain wordsIn older REWIND patients, death or severe low blood sugar occurred in 15.2% with dulaglutide versus 16.1% with placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Direction not reportedMortality or severe hypoglycemia, older subgroup
    Study

    n = 5,256

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Composite incidence
    15.2%
    DU aged ≥65 years
    Hazard ratio
    0.94 ratio
    DU versus PL aged ≥65 years
    Composite incidence
    16.1%
    PL aged ≥65 years

    Source sentences

    Summary
    The incidence of the composite safety outcome for patients aged ≥65 years was 399 of 2619 (15.2%) for DU-treated patients and 425 of 2,637 (16.1%) for PL-treated patients.
    3 context sentences
    Summary · context
    Between group treatment differences (HR [95% CI]) were 0.94 (0.82, 1.08) for patients ≥65 years of age and 0.82 (0.68, 1.00) for patients <65 years of age; interaction p-value = 0.277.
    Summary · context
    The primary objective of this post-hoc analysis was to evaluate DU safety in the REWIND patient subgroup populations categorized by age (≥ 65 and < 65 years) with regards to the occurrence of the composite safety outcome of overall mortality and severe hypoglycemia.
    Summary · context
    Of the 9,901 patients randomized in REWIND, a total of 5,256 (DU, 2,619; PL, 2,637) were aged ≥65 years.
  2. 02HumanRandomized controlled trialSafety outcome

    In REWIND patients aged <65 years, composite safety incidence was 8.1% with dulaglutide versus 9.7% with placebo.

    In plain wordsIn younger REWIND patients, death or severe low blood sugar occurred in 8.1% with dulaglutide versus 9.7% with placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableMortality or severe hypoglycemia, younger subgroup
    Study

    n = 4,645

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Composite incidence
    8.1%
    DU aged <65 years
    Hazard ratio
    0.82 ratio
    DU versus PL aged <65 years
    Composite incidence
    9.7%
    PL aged <65 years

    Source sentences

    Summary
    The incidence of the composite safety outcome for those aged <65 years was 188 of 2,330 (8.1%) for DU-treated patients and 224 of 2,315 (9.7%) for PL-treated patients.
    3 context sentences
    Summary · context
    Between group treatment differences (HR [95% CI]) were 0.94 (0.82, 1.08) for patients ≥65 years of age and 0.82 (0.68, 1.00) for patients <65 years of age; interaction p-value = 0.277.
    Summary · context
    The primary objective of this post-hoc analysis was to evaluate DU safety in the REWIND patient subgroup populations categorized by age (≥ 65 and < 65 years) with regards to the occurrence of the composite safety outcome of overall mortality and severe hypoglycemia.
    Summary · context
    Of the 9,901 patients randomized in REWIND, a total of 5,256 (DU, 2,619; PL, 2,637) were aged ≥65 years.
  3. 03HumanRandomized controlled trialSafety outcome

    In REWIND patients aged ≥65 years, first severe hypoglycemia incidence was 1.8% with dulaglutide versus 1.9% with placebo.

    In plain wordsIn older REWIND patients, first severe low blood sugar occurred in 1.8% with dulaglutide versus 1.9% with placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Direction not reportedFirst severe hypoglycemia, older subgroup
    Study

    n = 5,256

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Incidence
    1.8%
    DU aged ≥65 years
    Hazard ratio
    0.95 ratio
    DU versus PL aged ≥65 years
    Incidence
    1.9%
    PL aged ≥65 years

    Source sentences

    Summary
    The incidence of the secondary outcome of first occurrence of severe hypoglycemia for patients aged ≥65 years was 46 of 2619 (1.8%) for DU-treated patients and 49 of 2,637 (1.9%) for PL-treated patients.
    3 context sentences
    Summary · context
    Between group treatment differences (HR [95% CI]) were 0.95 (0.63, 1.42) for patients ≥65 years of age and 0.71 (0.39, 1.31) for patients <65 years of age; interaction p-value = 0.443.
    Summary · context
    The primary objective of this post-hoc analysis was to evaluate DU safety in the REWIND patient subgroup populations categorized by age (≥ 65 and < 65 years) with regards to the occurrence of the composite safety outcome of overall mortality and severe hypoglycemia.
    Summary · context
    Of the 9,901 patients randomized in REWIND, a total of 5,256 (DU, 2,619; PL, 2,637) were aged ≥65 years.
  4. 04HumanRandomized controlled trialSafety outcome

    In REWIND patients aged <65 years, first severe hypoglycemia incidence was 0.8% with dulaglutide versus 1.1% with placebo.

    In plain wordsIn younger REWIND patients, first severe low blood sugar occurred in 0.8% with dulaglutide versus 1.1% with placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Direction not reportedFirst severe hypoglycemia, younger subgroup
    Study

    n = 4,645

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Incidence
    0.8%
    DU aged <65 years
    Hazard ratio
    0.71 ratio
    DU versus PL aged <65 years
    Incidence
    1.1%
    PL aged <65 years

    Source sentences

    Summary
    The incidence of this outcome for patients <65 years was 18 of 2,330 (0.8%) for DU-treated patients and 25 of 2,315 (1.1%) for PL-treated patients.
    3 context sentences
    Summary · context
    Between group treatment differences (HR [95% CI]) were 0.95 (0.63, 1.42) for patients ≥65 years of age and 0.71 (0.39, 1.31) for patients <65 years of age; interaction p-value = 0.443.
    Summary · context
    The primary objective of this post-hoc analysis was to evaluate DU safety in the REWIND patient subgroup populations categorized by age (≥ 65 and < 65 years) with regards to the occurrence of the composite safety outcome of overall mortality and severe hypoglycemia.
    Summary · context
    Of the 9,901 patients randomized in REWIND, a total of 5,256 (DU, 2,619; PL, 2,637) were aged ≥65 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) aloneObservational studySafety outcome

    In REWIND patients, age did not significantly modify the dulaglutide-placebo difference in mortality or severe hypoglycemia.

    In plain wordsIn REWIND patients, the dulaglutide-placebo difference in death or severe low blood sugar did not significantly differ by age.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeComposite safety treatment-by-age interaction
    Study

    n = 9,901

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body

    Measurements

    Interaction p-value
    0.277 p-value
    composite safety outcome, treatment by age

    Source sentences

    Summary
    Between group treatment differences (HR [95% CI]) were 0.94 (0.82, 1.08) for patients ≥65 years of age and 0.82 (0.68, 1.00) for patients <65 years of age; interaction p-value = 0.277.
    2 context sentences
    Summary · context
    The primary objective of this post-hoc analysis was to evaluate DU safety in the REWIND patient subgroup populations categorized by age (≥ 65 and < 65 years) with regards to the occurrence of the composite safety outcome of overall mortality and severe hypoglycemia.
    Summary · context
    Of the 9,901 patients randomized in REWIND, a total of 5,256 (DU, 2,619; PL, 2,637) were aged ≥65 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).

  2. 06HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome

    In REWIND patients, age did not significantly modify the dulaglutide-placebo difference in first severe hypoglycemia.

    In plain wordsIn REWIND patients, the dulaglutide-placebo difference in first severe low blood sugar episodes did not significantly differ by age.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeSevere hypoglycemia treatment-by-age interaction
    Study

    n = 9,901

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Adverse events · Metabolic and weight

    Measurements

    Interaction p-value
    0.443 p-value
    severe hypoglycemia, treatment by age

    Source sentences

    Summary
    Between group treatment differences (HR [95% CI]) were 0.95 (0.63, 1.42) for patients ≥65 years of age and 0.71 (0.39, 1.31) for patients <65 years of age; interaction p-value = 0.443.
    2 context sentences
    Summary · context
    The primary objective of this post-hoc analysis was to evaluate DU safety in the REWIND patient subgroup populations categorized by age (≥ 65 and < 65 years) with regards to the occurrence of the composite safety outcome of overall mortality and severe hypoglycemia.
    Summary · context
    Of the 9,901 patients randomized in REWIND, a total of 5,256 (DU, 2,619; PL, 2,637) were aged ≥65 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).

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

    In REWIND patients, dulaglutide safety results did not indicate a different profile across age subgroups.

    In plain wordsIn REWIND patients, dulaglutide safety results did not show a different profile between older and younger patients.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeSafety profile across age subgroups
    Study

    n = 9,901

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    None of the results indicated that DU has a different safety profile across the age subgroups evaluated in this post-hoc analysis.
    3 context sentences
    Summary · context
    The safety profile of DU was reviewed based upon the results of subgroup analysis of treatment emergent adverse events and serious adverse events by preferred terms for comparing PL and DU for age subgroups (≥65 years of age versus <65 years).
    Summary · context
    The primary objective of this post-hoc analysis was to evaluate DU safety in the REWIND patient subgroup populations categorized by age (≥ 65 and < 65 years) with regards to the occurrence of the composite safety outcome of overall mortality and severe hypoglycemia.
    Summary · context
    Of the 9,901 patients randomized in REWIND, a total of 5,256 (DU, 2,619; PL, 2,637) were aged ≥65 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).

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

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