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Study · Randomized controlled trial · n = 300 · 2017

8 results

Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9).

Pozzilli P, Norwood P, Jódar E, Davies MJ, Ivanyi T, Jiang H, Woodward DB, Milicevic Z

Diabetes, obesity & metabolism10 Apr 2017Cited by 94 (Europe PMC)

PMID28294499 (opens in a new tab)DOI10.1111/dom.12937 (opens in a new tab)PepBankPUB-28294499
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In T2DM, dulaglutide added to glargine reduced HbA1c more than placebo added to glargine, with a difference of -0.77%.

    In plain wordsIn people with diabetes, adding dulaglutide reduced HbA1c more than adding placebo to glargine.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c change
    Study

    n = 300

    Comparator
    Placebo added to titrated glargine
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · subcutaneous · 28 weeksAs given in this study (human).

    Measurements

    HbA1c change from baseline
    −1.44%
    dulaglutide/glargine, week 28
    HbA1c change from baseline
    −0.67%
    placebo/glargine, week 28
    HbA1c change from baseline
    −15.74 mmol/mol
    dulaglutide/glargine, week 28
    HbA1c change from baseline
    −7.32 mmol/mol
    placebo/glargine, week 28
    HbA1c LS mean difference
    −0.77%
    dulaglutide/glargine minus placebo/glargine, week 28

    Source sentences

    Summary
    Least squares (LS) mean ± standard error (s.e.) HbA1c changes from baseline were -1.44 ± 0.09% (-15.74 ± 0.98 mmol/mol) with dulaglutide/glargine and -0.67 ± 0.09% (-7.32 ± 0.98 mmol/mol) with placebo/glargine at 28 weeks (LS mean difference [95% confidence interval] -0.77% [-0.97, -0.56]; P < .001).
    1 context sentence
    Summary · context
    Patients (N = 300) from this phase III, double-blind, parallel-arm, placebo-controlled study were randomized to weekly subcutaneous injections of dulaglutide 1.5 mg or placebo with titrated daily glargine (mean ± standard deviation baseline dose: 39 ± 22 U), with or without metformin (≥1500 mg/d).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In T2DM, dulaglutide added to glargine reduced weight versus placebo added to glargine, with a difference of -2.41 kg.

    In plain wordsIn people with diabetes, adding dulaglutide reduced weight compared with adding placebo to glargine.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseBody weight
    Study

    n = 300

    Comparator
    Placebo added to titrated glargine
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.5 mg weekly · subcutaneous · 28 weeksAs given in this study (human).

    Measurements

    Body weight LS mean difference
    −2.41 kg
    dulaglutide/glargine minus placebo/glargine, week 28

    Source sentences

    Summary
    Body weight decreased with dulaglutide/glargine and increased with placebo/glargine (LS mean difference: -2.41 ± 0.39 kg; P < .001).
    1 context sentence
    Summary · context
    Patients (N = 300) from this phase III, double-blind, parallel-arm, placebo-controlled study were randomized to weekly subcutaneous injections of dulaglutide 1.5 mg or placebo with titrated daily glargine (mean ± standard deviation baseline dose: 39 ± 22 U), with or without metformin (≥1500 mg/d).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In T2DM, glargine dose increases were smaller with added dulaglutide than placebo (13 versus 26 U).

    In plain wordsIn people with diabetes, glargine doses increased less with added dulaglutide than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseGlargine dose
    Study

    n = 300

    Comparator
    Placebo added to titrated glargine
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · subcutaneous · 28 weeksAs given in this study (human).

    Measurements

    Increase in glargine dose
    13 U
    dulaglutide/glargine
    Increase in glargine dose
    26 U
    placebo/glargine
    Increase in glargine dose
    0.1 U/kg
    dulaglutide/glargine
    Increase in glargine dose
    0.3 U/kg
    placebo/glargine
    Final glargine dose
    51 U
    dulaglutide/glargine
    Final glargine dose
    65 U
    placebo/glargine

    Source sentences

    Summary
    Increases from baseline in mean glargine dose were significantly smaller with dulaglutide/glargine vs placebo/glargine (13 ± 2 U [0.1 ± 0.02 U/kg] vs 26 ± 2 U [0.3 ± 0.02 U/kg], respectively; P < .001; LS mean ± s.e. final dose: dulaglutide/glargine, 51 ± 2 U; placebo/glargine, 65 ± 2 U).
    1 context sentence
    Summary · context
    Patients (N = 300) from this phase III, double-blind, parallel-arm, placebo-controlled study were randomized to weekly subcutaneous injections of dulaglutide 1.5 mg or placebo with titrated daily glargine (mean ± standard deviation baseline dose: 39 ± 22 U), with or without metformin (≥1500 mg/d).
  4. 04HumanRandomized controlled trialSafety outcome

    In T2DM, hypoglycaemia rates did not differ significantly between dulaglutide/glargine and placebo/glargine (7.69 versus 8.56 events/patient/year).

    In plain wordsIn people with diabetes, hypoglycaemia rates did not differ significantly between dulaglutide and placebo added to glargine.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeHypoglycaemia rate
    Study

    n = 300

    Comparator
    Placebo added to titrated glargine
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    1.5 mg weekly · subcutaneous · 28 weeksAs given in this study (human).

    Measurements

    Hypoglycaemia rate
    7.69 events/patient/year
    dulaglutide/glargine
    Hypoglycaemia rate
    8.56 events/patient/year
    placebo/glargine

    Source sentences

    Summary
    The hypoglycaemia rate (≤3.9 mmol/L threshold) was 7.69 ± 15.15 and 8.56 ± 16.13 events/patient/year, respectively (P = .488).
    1 context sentence
    Summary · context
    Patients (N = 300) from this phase III, double-blind, parallel-arm, placebo-controlled study were randomized to weekly subcutaneous injections of dulaglutide 1.5 mg or placebo with titrated daily glargine (mean ± standard deviation baseline dose: 39 ± 22 U), with or without metformin (≥1500 mg/d).
  5. 05HumanRandomized controlled trialSafety outcome

    In T2DM, one severe hypoglycaemia episode occurred with dulaglutide added to glargine.

    In plain wordsOne severe low-blood-sugar episode occurred in people with diabetes receiving dulaglutide and glargine.

    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 weekly · subcutaneous · 28 weeksAs given in this study (human).

    Measurements

    Severe hypoglycaemia episodes
    1 episode
    dulaglutide/glargine

    Source sentences

    Summary
    One episode of severe hypoglycaemia occurred in the dulaglutide/glargine group.
    1 context sentence
    Summary · context
    Patients (N = 300) from this phase III, double-blind, parallel-arm, placebo-controlled study were randomized to weekly subcutaneous injections of dulaglutide 1.5 mg or placebo with titrated daily glargine (mean ± standard deviation baseline dose: 39 ± 22 U), with or without metformin (≥1500 mg/d).
  6. 06HumanRandomized controlled trialSafety outcome

    In T2DM, nausea occurred in 12.0% with dulaglutide added to glargine.

    In plain wordsNausea occurred in 12.0% of people with diabetes receiving dulaglutide and glargine.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg weekly · subcutaneous · 28 weeksAs given in this study (human).

    Measurements

    Nausea incidence
    12%
    dulaglutide

    Source sentences

    Summary
    Common gastrointestinal adverse events with dulaglutide were nausea (12.0%), diarrhoea (11.3%) and vomiting (6.0%).
    1 context sentence
    Summary · context
    Patients (N = 300) from this phase III, double-blind, parallel-arm, placebo-controlled study were randomized to weekly subcutaneous injections of dulaglutide 1.5 mg or placebo with titrated daily glargine (mean ± standard deviation baseline dose: 39 ± 22 U), with or without metformin (≥1500 mg/d).
  7. 07HumanRandomized controlled trialSafety outcome

    In T2DM, diarrhoea occurred in 11.3% with dulaglutide added to glargine.

    In plain wordsDiarrhoea occurred in 11.3% of people with diabetes receiving dulaglutide and glargine.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableDiarrhoea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg weekly · subcutaneous · 28 weeksAs given in this study (human).

    Measurements

    Diarrhoea incidence
    11.3%
    dulaglutide

    Source sentences

    Summary
    Common gastrointestinal adverse events with dulaglutide were nausea (12.0%), diarrhoea (11.3%) and vomiting (6.0%).
    1 context sentence
    Summary · context
    Patients (N = 300) from this phase III, double-blind, parallel-arm, placebo-controlled study were randomized to weekly subcutaneous injections of dulaglutide 1.5 mg or placebo with titrated daily glargine (mean ± standard deviation baseline dose: 39 ± 22 U), with or without metformin (≥1500 mg/d).
  8. 08HumanRandomized controlled trialSafety outcome

    In T2DM, vomiting occurred in 6.0% with dulaglutide added to glargine.

    In plain wordsVomiting occurred in 6.0% of people with diabetes receiving dulaglutide and glargine.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableVomiting
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg weekly · subcutaneous · 28 weeksAs given in this study (human).

    Measurements

    Vomiting incidence
    6%
    dulaglutide

    Source sentences

    Summary
    Common gastrointestinal adverse events with dulaglutide were nausea (12.0%), diarrhoea (11.3%) and vomiting (6.0%).
    1 context sentence
    Summary · context
    Patients (N = 300) from this phase III, double-blind, parallel-arm, placebo-controlled study were randomized to weekly subcutaneous injections of dulaglutide 1.5 mg or placebo with titrated daily glargine (mean ± standard deviation baseline dose: 39 ± 22 U), with or without metformin (≥1500 mg/d).

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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