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Study · Randomized controlled trial · n = 300 · 2016

9 results

A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8).

Dungan KM, Weitgasser R, Perez Manghi F, Pintilei E, Fahrbach JL, Jiang HH, Shell J, Robertson KE

Diabetes, obesity & metabolism19 Feb 2016Cited by 78 (Europe PMC)

PMID26799540 (opens in a new tab)PMCIDPMC5067625 (opens in a new tab)DOI10.1111/dom.12634 (opens in a new tab)PepBankPUB-26799540
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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. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes on glimepiride, dulaglutide reduced HbA1c more than placebo.

    In plain wordsDulaglutide reduced HbA1c more than placebo in patients taking glimepiride.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c reduction
    Study

    n = 300

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg once weekly · 24 weeksAs given in this study (human).

    Measurements

    HbA1c difference
    −1.3%
    versus placebo

    Source sentences

    Summary
    Dulaglutide 1.5 mg was superior to placebo at 24 weeks for HbA1c reduction from baseline with a between-group HbA1c difference of -1.3% [95% confidence interval (CI) -1.6, -1.0] or -14 mmol/mol (95% CI -17, -11); p < 0.001.
  2. 02HumanRandomized controlled trialEfficacy outcome

    More dulaglutide-treated patients reached HbA1c below 7.0% than placebo-treated patients.

    In plain wordsMore patients reached the blood sugar target with dulaglutide than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseHbA1c below target
    Study

    n = 300

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg once weekly · 24 weeksAs given in this study (human).

    Measurements

    Target attainment
    55.3%
    dulaglutide
    Target attainment
    18.9%
    placebo

    Source sentences

    Summary
    A greater proportion of participants in the dulaglutide group reached an HbA1c level of <7.0% (53 mmol/mol) compared with placebo (55.3% vs 18.9%; p < 0.001).
  3. 03HumanRandomized controlled trialEfficacy outcome

    Dulaglutide decreased fasting serum glucose more than placebo in patients with type 2 diabetes.

    In plain wordsDulaglutide lowered fasting blood sugar more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseFasting serum glucose
    Study

    n = 300

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg once weekly · 24 weeksAs given in this study (human).

    Measurements

    Between-group difference
    −1.86 mmol/l
    versus placebo

    Source sentences

    Summary
    Dulaglutide significantly decreased fasting serum glucose from baseline compared with placebo (between-group difference -1.86 mmol/l (95% CI -2.58, -1.14) or -33.54 mg/dl (95% CI -46.55, -20.53); p < 0.001.
  4. 04HumanRandomized controlled trialEfficacy outcome

    Weight decreased from baseline with dulaglutide, but the difference versus placebo was not significant.

    In plain wordsWeight fell with dulaglutide, but the difference versus placebo was not significant.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeBody weight
    Study

    n = 300

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.5 mg once weekly · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Weight was decreased significantly from baseline in the dulaglutide group (p < 0.001); the between-group difference was not significant.
  5. 05HumanRandomized controlled trialSafety outcome

    Total hypoglycaemia was higher with dulaglutide than placebo in patients taking glimepiride.

    In plain wordsLow blood sugar occurred more often with dulaglutide than placebo during glimepiride treatment.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseTotal hypoglycaemia
    Study

    n = 300

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    1.5 mg once weekly · 24 weeksAs given in this study (human).

    Measurements

    Hypoglycaemia rate
    2.37 events/participant/year
    dulaglutide
    Hypoglycaemia rate
    0.07 events/participant/year
    placebo

    Source sentences

    Summary
    Total hypoglycaemia was higher with dulaglutide 1.5 mg vs placebo (2.37 and 0.07 events/participant/year, respectively; p = 0.025).
  6. 06HumanRandomized controlled trialSafety outcome

    Nausea occurred in 10.5% of dulaglutide-treated patients with type 2 diabetes.

    In plain wordsNausea occurred in 10.5% of patients receiving dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg once weekly · 24 weeksAs given in this study (human).

    Measurements

    Nausea
    10.5%
    dulaglutide

    Source sentences

    Summary
    The most common treatment-emergent adverse events for dulaglutide 1.5 mg were gastrointestinal: nausea (10.5%), diarrhoea (8.4%) and eructation (5.9%).
  7. 07HumanRandomized controlled trialSafety outcome

    Diarrhoea occurred in 8.4% of dulaglutide-treated patients.

    In plain wordsDiarrhoea occurred in 8.4% of patients receiving dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableDiarrhoea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg once weekly · 24 weeksAs given in this study (human).

    Measurements

    Diarrhoea
    8.4%
    dulaglutide

    Source sentences

    Summary
    The most common treatment-emergent adverse events for dulaglutide 1.5 mg were gastrointestinal: nausea (10.5%), diarrhoea (8.4%) and eructation (5.9%).
  8. 08HumanRandomized controlled trialSafety outcome

    Eructation occurred in 5.9% of dulaglutide-treated patients.

    In plain wordsBelching occurred in 5.9% of patients receiving dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableEructation
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg once weekly · 24 weeksAs given in this study (human).

    Measurements

    Eructation
    5.9%
    dulaglutide

    Source sentences

    Summary
    The most common treatment-emergent adverse events for dulaglutide 1.5 mg were gastrointestinal: nausea (10.5%), diarrhoea (8.4%) and eructation (5.9%).
  9. 09HumanRandomized controlled trialSafety outcome

    No severe hypoglycaemia was reported in this dulaglutide trial.

    In plain wordsThe trial reported no severe low blood sugar events.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableSevere hypoglycaemia
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    1.5 mg once weekly · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    No severe hypoglycaemia was reported.

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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