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Study · Randomized controlled trial · 2021

28 results

Efficacy of Dulaglutide Expanded Doses by Baseline A1C Categories: Post Hoc Analysis of AWARD-11

Frias J, Bonora E, Cox D, Kwan A, Raha S, Bethel A, Malik R

Journal of the Endocrine Society3 May 2021

PMCIDPMC8090394 (opens in a new tab)PepBankPUB-90678124

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 study28

27 results from studies that gave the peptide. 27 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, dulaglutide maintained A1C reductions across baseline categories at 52 weeks, ranging from -1.0 to -2.1%.

    In plain wordsDulaglutide maintained lower A1C than baseline across initial A1C categories in patients with diabetes.

    Outcome
    DecreaseA1C change across subgroups at 52 weeks
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 52 weeksAs given in this study (human).

    Measurements

    A1C change from baseline range across baseline A1C categories
    −1 to −2.1%
    dulaglutide 1.5 mg, 52 weeks

    Source sentences

    Summary
    DU 1.5 mg reduced A1C across all baseline A1C categories at 36 weeks (range, -1.0 to -2.2%) and effects were sustained through 52 weeks (range, -1.0 to -2.1%).
    2 context sentences
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C below 8%, dulaglutide 1.5 mg reduced A1C by 1.0%.

    In plain wordsIn patients with initial A1C below 8%, dulaglutide 1.5 mg lowered A1C from baseline.

    Outcome
    DecreaseA1C change with baseline below 8%
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −1%
    dulaglutide 1.5 mg, baseline A1C <8%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2;
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C below 8%, A1C fell by 1.2% with dulaglutide 3 mg versus 1.0% with 1.5 mg.

    In plain wordsIn patients with initial A1C below 8%, dulaglutide 3 mg lowered A1C more than 1.5 mg.

    Outcome
    DecreaseA1C change with baseline below 8%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −1.2%
    dulaglutide 3 mg, baseline A1C <8%, 36 weeks
    A1C change from baseline (least-squares mean)
    −1%
    dulaglutide 1.5 mg, baseline A1C <8%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2;
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C below 8%, A1C fell by 1.2% with dulaglutide 4.5 mg versus 1.0% with 1.5 mg.

    In plain wordsIn patients with initial A1C below 8%, dulaglutide 4.5 mg lowered A1C more than 1.5 mg.

    Outcome
    DecreaseA1C change with baseline below 8%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −1.2%
    dulaglutide 4.5 mg, baseline A1C <8%, 36 weeks
    A1C change from baseline (least-squares mean)
    −1%
    dulaglutide 1.5 mg, baseline A1C <8%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2;
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 8 to below 9%, dulaglutide 1.5 mg reduced A1C by 1.4%.

    In plain wordsDulaglutide 1.5 mg lowered A1C from baseline in patients with initial A1C 8 to below 9%.

    Outcome
    DecreaseA1C change with baseline 8 to below 9%
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −1.4%
    dulaglutide 1.5 mg, baseline A1C 8-<9%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8;
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 8 to below 9%, A1C fell by 1.6% with dulaglutide 3 mg versus 1.4% with 1.5 mg.

    In plain wordsDulaglutide 3 mg lowered A1C more than 1.5 mg in patients with initial A1C 8 to below 9%.

    Outcome
    DecreaseA1C change with baseline 8 to below 9%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −1.6%
    dulaglutide 3 mg, baseline A1C 8-<9%, 36 weeks
    A1C change from baseline (least-squares mean)
    −1.4%
    dulaglutide 1.5 mg, baseline A1C 8-<9%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8;
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 8 to below 9%, A1C fell by 1.8% with dulaglutide 4.5 mg versus 1.4% with 1.5 mg.

    In plain wordsDulaglutide 4.5 mg lowered A1C more than 1.5 mg in patients with initial A1C 8 to below 9%.

    Outcome
    DecreaseA1C change with baseline 8 to below 9%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −1.8%
    dulaglutide 4.5 mg, baseline A1C 8-<9%, 36 weeks
    A1C change from baseline (least-squares mean)
    −1.4%
    dulaglutide 1.5 mg, baseline A1C 8-<9%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8;
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 9 to below 10%, dulaglutide 1.5 mg reduced A1C by 2.1%.

    In plain wordsDulaglutide 1.5 mg lowered A1C from baseline in patients with initial A1C 9 to below 10%.

    Outcome
    DecreaseA1C change with baseline 9 to below 10%
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −2.1%
    dulaglutide 1.5 mg, baseline A1C 9-<10%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8; A1C 9-<10%, -2.1, -2.2, -2.3;
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 9 to below 10%, A1C fell by 2.2% with dulaglutide 3 mg versus 2.1% with 1.5 mg.

    In plain wordsDulaglutide 3 mg lowered A1C more than 1.5 mg in patients with initial A1C 9 to below 10%.

    Outcome
    DecreaseA1C change with baseline 9 to below 10%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −2.2%
    dulaglutide 3 mg, baseline A1C 9-<10%, 36 weeks
    A1C change from baseline (least-squares mean)
    −2.1%
    dulaglutide 1.5 mg, baseline A1C 9-<10%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8; A1C 9-<10%, -2.1, -2.2, -2.3;
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 9 to below 10%, A1C fell by 2.3% with dulaglutide 4.5 mg versus 2.1% with 1.5 mg.

    In plain wordsDulaglutide 4.5 mg lowered A1C more than 1.5 mg in patients with initial A1C 9 to below 10%.

    Outcome
    DecreaseA1C change with baseline 9 to below 10%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −2.3%
    dulaglutide 4.5 mg, baseline A1C 9-<10%, 36 weeks
    A1C change from baseline (least-squares mean)
    −2.1%
    dulaglutide 1.5 mg, baseline A1C 9-<10%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8; A1C 9-<10%, -2.1, -2.2, -2.3;
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C at least 10%, dulaglutide 1.5 mg reduced A1C by 2.2%.

    In plain wordsDulaglutide 1.5 mg lowered A1C from baseline in patients with initial A1C at least 10%.

    Outcome
    DecreaseA1C change with baseline at least 10%
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −2.2%
    dulaglutide 1.5 mg, baseline A1C ≥10%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8; A1C 9-<10%, -2.1, -2.2, -2.3; A1C ≥10%, -2.2, -2.5, -3.2; interaction p<0.001).
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  12. 12HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C at least 10%, A1C fell by 2.5% with dulaglutide 3 mg versus 2.2% with 1.5 mg.

    In plain wordsDulaglutide 3 mg lowered A1C more than 1.5 mg in patients with initial A1C at least 10%.

    Outcome
    DecreaseA1C change with baseline at least 10%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −2.5%
    dulaglutide 3 mg, baseline A1C ≥10%, 36 weeks
    A1C change from baseline (least-squares mean)
    −2.2%
    dulaglutide 1.5 mg, baseline A1C ≥10%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8; A1C 9-<10%, -2.1, -2.2, -2.3; A1C ≥10%, -2.2, -2.5, -3.2; interaction p<0.001).
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  13. 13HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C at least 10%, A1C fell by 3.2% with dulaglutide 4.5 mg versus 2.2% with 1.5 mg.

    In plain wordsDulaglutide 4.5 mg lowered A1C more than 1.5 mg in patients with initial A1C at least 10%.

    Outcome
    DecreaseA1C change with baseline at least 10%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    A1C change from baseline (least-squares mean)
    −3.2%
    dulaglutide 4.5 mg, baseline A1C ≥10%, 36 weeks
    A1C change from baseline (least-squares mean)
    −2.2%
    dulaglutide 1.5 mg, baseline A1C ≥10%, 36 weeks

    Source sentences

    Summary
    A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8; A1C 9-<10%, -2.1, -2.2, -2.3; A1C ≥10%, -2.2, -2.5, -3.2; interaction p<0.001).
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  14. 14HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C below 8%, 75% reached A1C below 7% with dulaglutide 1.5 mg.

    In plain wordsWith dulaglutide 1.5 mg, 75% of patients with initial A1C below 8% reached A1C below 7%.

    Outcome
    Not applicableA1C target with baseline below 8%
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    75%
    dulaglutide 1.5 mg, baseline A1C <8%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  15. 15HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 8 to below 9%, 61% reached A1C below 7% with dulaglutide 1.5 mg.

    In plain wordsWith dulaglutide 1.5 mg, 61% of patients with initial A1C 8 to below 9% reached A1C below 7%.

    Outcome
    Not applicableA1C target with baseline 8 to below 9%
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    61%
    dulaglutide 1.5 mg, baseline A1C 8-<9%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  16. 16HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 9 to below 10%, 46% reached A1C below 7% with dulaglutide 1.5 mg.

    In plain wordsWith dulaglutide 1.5 mg, 46% of patients with initial A1C 9 to below 10% reached A1C below 7%.

    Outcome
    Not applicableA1C target with baseline 9 to below 10%
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    46%
    dulaglutide 1.5 mg, baseline A1C 9-<10%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  17. 17HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C at least 10%, 19% reached A1C below 7% with dulaglutide 1.5 mg.

    In plain wordsWith dulaglutide 1.5 mg, 19% of patients with initial A1C at least 10% reached A1C below 7%.

    Outcome
    Not applicableA1C target with baseline at least 10%
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    19%
    dulaglutide 1.5 mg, baseline A1C ≥10%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  18. 18HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C below 8%, 87% reached A1C below 7% with dulaglutide 3 mg versus 75% with 1.5 mg.

    In plain wordsMore patients with initial A1C below 8% reached A1C below 7% with dulaglutide 3 mg than with 1.5 mg.

    Outcome
    IncreaseA1C target with baseline below 8%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    87%
    dulaglutide 3 mg, baseline A1C <8%, 36 weeks
    Patients achieving A1C <7%
    75%
    dulaglutide 1.5 mg, baseline A1C <8%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  19. 19HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 8 to below 9%, 64% reached A1C below 7% with dulaglutide 3 mg versus 61% with 1.5 mg.

    In plain wordsMore patients with initial A1C 8 to below 9% reached A1C below 7% with dulaglutide 3 mg than with 1.5 mg.

    Outcome
    IncreaseA1C target with baseline 8 to below 9%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    64%
    dulaglutide 3 mg, baseline A1C 8-<9%, 36 weeks
    Patients achieving A1C <7%
    61%
    dulaglutide 1.5 mg, baseline A1C 8-<9%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  20. 20HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 9 to below 10%, 51% reached A1C below 7% with dulaglutide 3 mg versus 46% with 1.5 mg.

    In plain wordsMore patients with initial A1C 9 to below 10% reached A1C below 7% with dulaglutide 3 mg than with 1.5 mg.

    Outcome
    IncreaseA1C target with baseline 9 to below 10%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    51%
    dulaglutide 3 mg, baseline A1C 9-<10%, 36 weeks
    Patients achieving A1C <7%
    46%
    dulaglutide 1.5 mg, baseline A1C 9-<10%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  21. 21HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C at least 10%, 33% reached A1C below 7% with dulaglutide 3 mg versus 19% with 1.5 mg.

    In plain wordsMore patients with initial A1C at least 10% reached A1C below 7% with dulaglutide 3 mg than with 1.5 mg.

    Outcome
    IncreaseA1C target with baseline at least 10%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    33%
    dulaglutide 3 mg, baseline A1C ≥10%, 36 weeks
    Patients achieving A1C <7%
    19%
    dulaglutide 1.5 mg, baseline A1C ≥10%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  22. 22HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C below 8%, 83% reached A1C below 7% with dulaglutide 4.5 mg versus 75% with 1.5 mg.

    In plain wordsMore patients with initial A1C below 8% reached A1C below 7% with dulaglutide 4.5 mg than with 1.5 mg.

    Outcome
    IncreaseA1C target with baseline below 8%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    83%
    dulaglutide 4.5 mg, baseline A1C <8%, 36 weeks
    Patients achieving A1C <7%
    75%
    dulaglutide 1.5 mg, baseline A1C <8%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  23. 23HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 8 to below 9%, 73% reached A1C below 7% with dulaglutide 4.5 mg versus 61% with 1.5 mg.

    In plain wordsMore patients with initial A1C 8 to below 9% reached A1C below 7% with dulaglutide 4.5 mg than with 1.5 mg.

    Outcome
    IncreaseA1C target with baseline 8 to below 9%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    73%
    dulaglutide 4.5 mg, baseline A1C 8-<9%, 36 weeks
    Patients achieving A1C <7%
    61%
    dulaglutide 1.5 mg, baseline A1C 8-<9%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  24. 24HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C 9 to below 10%, 64% reached A1C below 7% with dulaglutide 4.5 mg versus 46% with 1.5 mg.

    In plain wordsMore patients with initial A1C 9 to below 10% reached A1C below 7% with dulaglutide 4.5 mg than with 1.5 mg.

    Outcome
    IncreaseA1C target with baseline 9 to below 10%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    64%
    dulaglutide 4.5 mg, baseline A1C 9-<10%, 36 weeks
    Patients achieving A1C <7%
    46%
    dulaglutide 1.5 mg, baseline A1C 9-<10%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  25. 25HumanRandomized controlled trialEfficacy outcome

    In patients with baseline A1C at least 10%, 55% reached A1C below 7% with dulaglutide 4.5 mg versus 19% with 1.5 mg.

    In plain wordsMore patients with initial A1C at least 10% reached A1C below 7% with dulaglutide 4.5 mg than with 1.5 mg.

    Outcome
    IncreaseA1C target with baseline at least 10%
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg weekly · 36 weeksAs given in this study (human).

    Measurements

    Patients achieving A1C <7%
    55%
    dulaglutide 4.5 mg, baseline A1C ≥10%, 36 weeks
    Patients achieving A1C <7%
    19%
    dulaglutide 1.5 mg, baseline A1C ≥10%, 36 weeks

    Source sentences

    Summary
    Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096).
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  26. 26HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, dose-related A1C improvements across baseline categories persisted at 52 weeks with dulaglutide.

    In plain wordsHigher dulaglutide doses maintained greater A1C improvement than 1.5 mg across initial A1C categories in patients with diabetes.

    Outcome
    DecreaseDose response at 52 weeks
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 4.5 mg weekly · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Similar patterns of dose-related improvement in A1C and proportions of patients achieving A1C <7% across baseline A1C categories were observed at 52 weeks.
    3 context sentences
    Summary · context
    A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.
  27. 27HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, dose-related improvements in A1C target attainment across baseline categories persisted at 52 weeks with dulaglutide.

    In plain wordsHigher dulaglutide doses maintained greater A1C target attainment than 1.5 mg across initial A1C categories in patients with diabetes.

    Outcome
    IncreaseA1C target dose response at 52 weeks
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 4.5 mg weekly · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Similar patterns of dose-related improvement in A1C and proportions of patients achieving A1C <7% across baseline A1C categories were observed at 52 weeks.
    3 context sentences
    Summary · context
    More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs.
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.

Studies that did not test the peptide alone1

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. 28HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome

    In patients with diabetes receiving dulaglutide, gastrointestinal adverse events were similar across baseline A1C subgroups.

    In plain wordsDigestive adverse events were similar across initial A1C groups in patients with diabetes receiving dulaglutide.

    Outcome
    No significant changeGastrointestinal adverse events by baseline A1C
    Study

    n: not reported in source

    Comparator
    Other baseline A1C subgroups
    Analysis
    Exploratory
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal

    Source sentences

    Summary
    Gastrointestinal adverse events were similar between A1C subgroups.
    2 context sentences
    Summary · context
    Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614).
    Summary · context
    All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose.

    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.

Publication types

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