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Study · Other design · 2021

12 results

Efficacy and safety of dulaglutide 3.0 and 4.5 mg in patients aged younger than 65 and 65 years or older: Post hoc analysis of the AWARD-11 trial.

Frias JP, Bonora E, Nevárez Ruiz L, Hsia SH, Jung H, Raha S, Cox DA, Bethel MA, Konig M

Diabetes, obesity & metabolism8 Jul 2021Cited by 9 (Europe PMC)

PMID34159708 (opens in a new tab)PMCIDPMC8518960 (opens in a new tab)DOI10.1111/dom.14469 (opens in a new tab)PepBankPUB-34159708
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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 study12

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanOther designEfficacy outcome

    In both age subgroups, dulaglutide 3.0 mg reduced HbA1c more than 1.5 mg.

    In plain wordsIn both age subgroups, dulaglutide 3.0 mg reduced HbA1c more than 1.5 mg.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c reduction by age subgroup
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3.0 mgAs given in this study (human).

    Source sentences

    Summary
    In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg…
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…
  2. 02HumanOther designEfficacy outcome

    In both age subgroups, dulaglutide 4.5 mg reduced HbA1c more than 1.5 mg.

    In plain wordsIn both age subgroups, dulaglutide 4.5 mg reduced HbA1c more than 1.5 mg.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c reduction by age subgroup
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mgAs given in this study (human).

    Source sentences

    Summary
    In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg…
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…
  3. 03HumanOther designEfficacy outcome

    In both age subgroups, dulaglutide 3.0 mg reduced weight more than 1.5 mg.

    In plain wordsIn both age subgroups, dulaglutide 3.0 mg reduced weight more than 1.5 mg.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseBody weight reduction by age subgroup
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mgAs given in this study (human).

    Source sentences

    Summary
    In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg…
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…
  4. 04HumanOther designEfficacy outcome

    In both age subgroups, dulaglutide 4.5 mg reduced weight more than 1.5 mg.

    In plain wordsIn both age subgroups, dulaglutide 4.5 mg reduced weight more than 1.5 mg.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseBody weight reduction by age subgroup
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    4.5 mgAs given in this study (human).

    Source sentences

    Summary
    In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg…
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…
  5. 05HumanOther designEfficacy outcome

    In both age subgroups, composite attainment of HbA1c below 7% without weight gain or documented symptomatic or severe hypoglycaemia was greater with dulaglutide 3.0 mg versus 1.5 mg.

    In plain wordsIn both age subgroups, dulaglutide 3.0 mg improved combined blood sugar, weight and hypoglycaemia target attainment versus 1.5 mg.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseComposite glycemic target without weight gain or hypoglycaemia
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3.0 mgAs given in this study (human).

    Source sentences

    Summary
    In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg…
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…
  6. 06HumanOther designEfficacy outcome

    In both age subgroups, composite attainment of HbA1c below 7% without weight gain or documented symptomatic or severe hypoglycaemia was greater with dulaglutide 4.5 mg versus 1.5 mg.

    In plain wordsIn both age subgroups, dulaglutide 4.5 mg improved combined blood sugar, weight and hypoglycaemia target attainment versus 1.5 mg.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseComposite glycemic target without weight gain or hypoglycaemia
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mgAs given in this study (human).

    Source sentences

    Summary
    In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg…
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…
  7. 07HumanOther designSafety outcome

    In trial patients, the safety profile of dulaglutide 3.0 mg was consistent with 1.5 mg.

    In plain wordsIn trial patients, the safety profile of dulaglutide 3.0 mg was consistent with 1.5 mg.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeSafety profile versus lower dose
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    3.0 mgAs given in this study (human).

    Source sentences

    Summary
    The safety profile for the additional dulaglutide doses was consistent with that of dulaglutide 1.5 mg and was similar between the age subgroups.
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…
  8. 08HumanOther designSafety outcome

    In trial patients, the safety profile of dulaglutide 4.5 mg was consistent with 1.5 mg.

    In plain wordsIn trial patients, the safety profile of dulaglutide 4.5 mg was consistent with 1.5 mg.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeSafety profile versus lower dose
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    4.5 mgAs given in this study (human).

    Source sentences

    Summary
    The safety profile for the additional dulaglutide doses was consistent with that of dulaglutide 1.5 mg and was similar between the age subgroups.
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…

Studies that did not test the peptide alone4

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. 09HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyEfficacy outcome

    In trial patients, age did not significantly modify the dulaglutide dose effect on HbA1c reduction.

    In plain wordsIn trial patients, age did not significantly modify the dulaglutide dose effect on HbA1c reduction.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeTreatment-by-age interaction for HbA1c
    Study

    n = 1,842

    Comparator
    Age subgroups
    Outcome group
    Glycemic control · Metabolic and weight

    Source sentences

    Summary
    In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg…
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…

    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. 10HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyEfficacy outcome

    In trial patients, age did not significantly modify the dulaglutide dose effect on weight reduction.

    In plain wordsIn trial patients, age did not significantly modify the dulaglutide dose effect on weight reduction.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeTreatment-by-age interaction for weight
    Study

    n = 1,842

    Comparator
    Age subgroups
    Outcome group
    Body weight · Metabolic and weight

    Source sentences

    Summary
    In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg…
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…

    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. 11HumanNot a test of Dulaglutide (Trulicity) aloneObservational studyEfficacy outcome

    In trial patients, the composite endpoint showed no significant treatment-by-age interaction.

    In plain wordsIn trial patients, the composite endpoint showed no significant treatment-by-age interaction.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeTreatment-by-age interaction for composite target
    Study

    n = 1,842

    Comparator
    Age subgroups
    Outcome group
    Glycemic control · Metabolic and weight

    Source sentences

    Summary
    In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg…
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…

    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).

  4. 12HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome

    In trial patients receiving dulaglutide, safety profiles were similar between age subgroups.

    In plain wordsIn trial patients receiving dulaglutide, safety profiles were similar between age subgroups.

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

    n = 1,842

    Comparator
    Age subgroups
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    The safety profile for the additional dulaglutide doses was consistent with that of dulaglutide 1.5 mg and was similar between the age subgroups.
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).
    Summary · context
    Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for…

    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, 02:25 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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