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Study · Randomized controlled trial · 2015

14 results

Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study.

Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z

Diabetes, obesity & metabolism20 May 2015Cited by 122 (Europe PMC)

PMID25912221 (opens in a new tab)PMCIDPMC5008205 (opens in a new tab)DOI10.1111/dom.12479 (opens in a new tab)PepBankPUB-25912221
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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 study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    Dulaglutide 1.5 mg reduced HbA1c more than sitagliptin in metformin-treated patients with type 2 diabetes.

    In plain wordsDulaglutide 1.5 mg lowered HbA1c more than sitagliptin in patients taking metformin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c change
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg · 104 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −0.99%
    1.5 mg
    HbA1c change
    −0.32%
    sitagliptin

    Source sentences

    Summary
    Changes in HbA1c at 104 weeks were (least squares mean ± standard error) -0.99 ± 0.06% (-10.82 ± 0.66 mmol/mol), -0.71 ± 0.07% (-7.76 ± 0.77 mmol/mol) and -0.32 ± 0.06% (-3.50 ± 0.66 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg and sitagliptin, respectively (p < 0.001, both dulaglutide doses vs sitagliptin).
    2 context sentences
    Summary · context
    Change in glycated haemoglobin (HbA1c) concentration from baseline was the primary efficacy measure.
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    Dulaglutide 0.75 mg reduced HbA1c more than sitagliptin in metformin-treated patients with type 2 diabetes.

    In plain wordsDulaglutide 0.75 mg lowered HbA1c more than sitagliptin in patients taking metformin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c change
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg · 104 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −0.71%
    0.75 mg
    HbA1c change
    −0.32%
    sitagliptin

    Source sentences

    Summary
    Changes in HbA1c at 104 weeks were (least squares mean ± standard error) -0.99 ± 0.06% (-10.82 ± 0.66 mmol/mol), -0.71 ± 0.07% (-7.76 ± 0.77 mmol/mol) and -0.32 ± 0.06% (-3.50 ± 0.66 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg and sitagliptin, respectively (p < 0.001, both dulaglutide doses vs sitagliptin).
    2 context sentences
    Summary · context
    Change in glycated haemoglobin (HbA1c) concentration from baseline was the primary efficacy measure.
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    Dulaglutide 1.5 mg produced greater weight loss than sitagliptin in metformin-treated patients.

    In plain wordsDulaglutide 1.5 mg produced more weight loss than sitagliptin in patients taking metformin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseWeight loss
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.5 mg · 104 weeksAs given in this study (human).

    Measurements

    Weight loss
    2.88 kg
    1.5 mg
    Weight loss
    1.75 kg
    sitagliptin

    Source sentences

    Summary
    Weight loss was greater with dulaglutide 1.5 mg (p < 0.001) and similar with 0.75 mg versus sitagliptin (2.88 ± 0.25, 2.39 ± 0.26 and 1.75 ± 0.25 kg, respectively).
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    Weight loss with dulaglutide 0.75 mg was similar to sitagliptin in metformin-treated patients.

    In plain wordsWeight loss was similar with dulaglutide 0.75 mg and sitagliptin in patients taking metformin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeWeight loss
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.75 mg · 104 weeksAs given in this study (human).

    Measurements

    Weight loss
    2.39 kg
    0.75 mg
    Weight loss
    1.75 kg
    sitagliptin

    Source sentences

    Summary
    Weight loss was greater with dulaglutide 1.5 mg (p < 0.001) and similar with 0.75 mg versus sitagliptin (2.88 ± 0.25, 2.39 ± 0.26 and 1.75 ± 0.25 kg, respectively).
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  5. 05HumanRandomized controlled trialSafety outcome

    Nausea occurred in 17% with dulaglutide 1.5 mg versus 7% with sitagliptin.

    In plain wordsNausea occurred in 17% with dulaglutide 1.5 mg versus 7% with sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseNausea
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg · 104 weeksAs given in this study (human).

    Measurements

    Nausea
    17%
    1.5 mg
    Nausea
    7%
    sitagliptin

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively).
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    Nausea occurred in 15% with dulaglutide 0.75 mg versus 7% with sitagliptin.

    In plain wordsNausea occurred in 15% with dulaglutide 0.75 mg versus 7% with sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseNausea
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.75 mg · 104 weeksAs given in this study (human).

    Measurements

    Nausea
    15%
    0.75 mg
    Nausea
    7%
    sitagliptin

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively).
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  7. 07HumanRandomized controlled trialSafety outcome

    Diarrhoea occurred in 16% with dulaglutide 1.5 mg versus 6% with sitagliptin.

    In plain wordsDiarrhoea occurred in 16% with dulaglutide 1.5 mg versus 6% with sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseDiarrhoea
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg · 104 weeksAs given in this study (human).

    Measurements

    Diarrhoea
    16%
    1.5 mg
    Diarrhoea
    6%
    sitagliptin

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively).
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  8. 08HumanRandomized controlled trialSafety outcome

    Diarrhoea occurred in 12% with dulaglutide 0.75 mg versus 6% with sitagliptin.

    In plain wordsDiarrhoea occurred in 12% with dulaglutide 0.75 mg versus 6% with sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseDiarrhoea
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.75 mg · 104 weeksAs given in this study (human).

    Measurements

    Diarrhoea
    12%
    0.75 mg
    Diarrhoea
    6%
    sitagliptin

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively).
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  9. 09HumanRandomized controlled trialSafety outcome

    Vomiting occurred in 14% with dulaglutide 1.5 mg versus 4% with sitagliptin.

    In plain wordsVomiting occurred in 14% with dulaglutide 1.5 mg versus 4% with sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseVomiting
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg · 104 weeksAs given in this study (human).

    Measurements

    Vomiting
    14%
    1.5 mg
    Vomiting
    4%
    sitagliptin

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively).
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  10. 10HumanRandomized controlled trialSafety outcome

    Vomiting occurred in 8% with dulaglutide 0.75 mg versus 4% with sitagliptin.

    In plain wordsVomiting occurred in 8% with dulaglutide 0.75 mg versus 4% with sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseVomiting
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.75 mg · 104 weeksAs given in this study (human).

    Measurements

    Vomiting
    8%
    0.75 mg
    Vomiting
    4%
    sitagliptin

    Source sentences

    Summary
    Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively).
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  11. 11HumanRandomized controlled trialSafety outcome

    Pancreatic safety was similar across dulaglutide and sitagliptin groups.

    In plain wordsPancreatic safety was similar with dulaglutide and sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changePancreatic safety
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 104 weeksAs given in this study (human).

    Source sentences

    Summary
    Pancreatic, thyroid, cardiovascular and hypersensitivity safety were similar across groups.
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  12. 12HumanRandomized controlled trialSafety outcome

    Thyroid safety was similar across dulaglutide and sitagliptin groups.

    In plain wordsThyroid safety was similar with dulaglutide and sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeThyroid safety
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    Dose not stated · 104 weeksAs given in this study (human).

    Source sentences

    Summary
    Pancreatic, thyroid, cardiovascular and hypersensitivity safety were similar across groups.
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  13. 13HumanRandomized controlled trialSafety outcome

    Cardiovascular safety was similar across dulaglutide and sitagliptin groups.

    In plain wordsHeart and blood vessel safety was similar with dulaglutide and sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeCardiovascular safety
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Adverse events · Cardiovascular
    Studied dose
    Dose not stated · 104 weeksAs given in this study (human).

    Source sentences

    Summary
    Pancreatic, thyroid, cardiovascular and hypersensitivity safety were similar across groups.
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.
  14. 14HumanRandomized controlled trialSafety outcome

    Hypersensitivity safety was similar across dulaglutide and sitagliptin groups.

    In plain wordsAllergic reaction safety was similar with dulaglutide and sitagliptin.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeHypersensitivity safety
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg
    Outcome group
    Adverse events · Immune and inflammation
    Studied dose
    Dose not stated · 104 weeksAs given in this study (human).

    Source sentences

    Summary
    Pancreatic, thyroid, cardiovascular and hypersensitivity safety were similar across groups.
    1 context sentence
    Summary · context
    This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2/3Results postedNCT00734474

A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin

Eli Lilly and Companyn = 1,202Aug 2008 to Jul 2012

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 20 Apr 2015

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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