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Study · Randomized controlled trial · 2014

6 results

Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5).

Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D

Diabetes, obesity & metabolism22 May 2014Cited by 52 (Europe PMC)

PMID24762094 (opens in a new tab)DOI10.1111/dom.12305 (opens in a new tab)PepBankPUB-24762094
Publisher pagePubMedAsk about this study
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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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialOther

    In the AWARD-5 dose-finding study, dulaglutide 1.5 mg was selected as optimal.

    In plain wordsIn the AWARD-5 dose study, dulaglutide 1.5 mg was selected as optimal.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableOptimal dose selection
    Study

    n: not reported in source

    Outcome group
    Overall treatment effect · Metabolic and weight
    Studied dose
    1.5 mg weeklyAs given in this study (human).

    Source sentences

    Summary
    Dulaglutide 1.5 mg was determined to be the optimal dose.
    1 context sentence
    Summary · context
    Type 2 diabetes (T2D) patients on metformin were randomized 3 : 1 : 1 to seven dulaglutide doses, sitagliptin (100 mg), or placebo.
  2. 02HumanRandomized controlled trialOther

    In the AWARD-5 dose-finding study, dulaglutide 0.75 mg met criteria for the second dose.

    In plain wordsIn the AWARD-5 dose study, dulaglutide 0.75 mg met criteria for the second dose.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableSecond dose selection
    Study

    n: not reported in source

    Outcome group
    Overall treatment effect · Metabolic and weight
    Studied dose
    0.75 mg weeklyAs given in this study (human).

    Source sentences

    Summary
    Dulaglutide 0.75 mg met criteria for the second dose.
    1 context sentence
    Summary · context
    Type 2 diabetes (T2D) patients on metformin were randomized 3 : 1 : 1 to seven dulaglutide doses, sitagliptin (100 mg), or placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, dulaglutide 1.5 mg had the greatest HbA1c reduction versus sitagliptin among tested doses.

    In plain wordsIn type 2 diabetes, dulaglutide 1.5 mg had the greatest HbA1c reduction versus sitagliptin among tested doses.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c
    Study

    n: not reported in source

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

    Measurements

    HbA1c difference
    −0.63%
    versus sitagliptin

    Source sentences

    Summary
    Dulaglutide 1.5 mg showed the greatest Bayesian mean change from baseline (95% credible interval) in HbA1c versus sitagliptin at 52 weeks -0.63 (-0.98 to -0.20)%.
    1 context sentence
    Summary · context
    Type 2 diabetes (T2D) patients on metformin were randomized 3 : 1 : 1 to seven dulaglutide doses, sitagliptin (100 mg), or placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, dulaglutide 2.0 mg had the greatest placebo-adjusted weight reduction among tested doses.

    In plain wordsIn type 2 diabetes, dulaglutide 2.0 mg had the greatest weight reduction versus placebo among tested doses.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseBody weight
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2.0 mg weekly · 26 weeksAs given in this study (human).

    Measurements

    Weight difference
    −1.99 kg
    versus placebo

    Source sentences

    Summary
    Dulaglutide 2.0 mg showed the greatest placebo-adjusted mean change in weight [-1.99 (-2.88 to -1.20) kg] and in PR [0.78 (-2.10 to 3.80) bpm].
    2 context sentences
    Summary · context
    Patients were adaptively randomized to dulaglutide doses using available data on the basis of a clinical utility index (CUI) of glycosylated haemoglobin A1c (HbA1c) versus sitagliptin at 52 weeks and weight, pulse rate (PR) and diastolic blood pressure (DBP) versus placebo at 26 weeks.
    Summary · context
    Type 2 diabetes (T2D) patients on metformin were randomized 3 : 1 : 1 to seven dulaglutide doses, sitagliptin (100 mg), or placebo.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, the pulse-rate estimate for dulaglutide 2.0 mg versus placebo had a credible interval spanning zero.

    In plain wordsIn type 2 diabetes, dulaglutide 2.0 mg did not clearly change pulse rate versus placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Direction not reportedPulse rate
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    2.0 mg weekly · 26 weeksAs given in this study (human).

    Measurements

    Pulse-rate difference
    0.78 bpm
    versus placebo

    Source sentences

    Summary
    Dulaglutide 2.0 mg showed the greatest placebo-adjusted mean change in weight [-1.99 (-2.88 to -1.20) kg] and in PR [0.78 (-2.10 to 3.80) bpm].
    2 context sentences
    Summary · context
    Patients were adaptively randomized to dulaglutide doses using available data on the basis of a clinical utility index (CUI) of glycosylated haemoglobin A1c (HbA1c) versus sitagliptin at 52 weeks and weight, pulse rate (PR) and diastolic blood pressure (DBP) versus placebo at 26 weeks.
    Summary · context
    Type 2 diabetes (T2D) patients on metformin were randomized 3 : 1 : 1 to seven dulaglutide doses, sitagliptin (100 mg), or placebo.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, the diastolic pressure estimate for dulaglutide 1.5 mg versus placebo had a credible interval spanning zero.

    In plain wordsIn type 2 diabetes, dulaglutide 1.5 mg did not clearly change diastolic pressure versus placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Direction not reportedDiastolic blood pressure
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    1.5 mg weekly · 26 weeksAs given in this study (human).

    Measurements

    Diastolic pressure difference
    −0.62 mmHg
    versus placebo

    Source sentences

    Summary
    Dulaglutide 1.5 mg showed the greatest placebo-adjusted mean change in DBP [-0.62 (-3.40 to 2.30) mmHg].
    2 context sentences
    Summary · context
    Patients were adaptively randomized to dulaglutide doses using available data on the basis of a clinical utility index (CUI) of glycosylated haemoglobin A1c (HbA1c) versus sitagliptin at 52 weeks and weight, pulse rate (PR) and diastolic blood pressure (DBP) versus placebo at 26 weeks.
    Summary · context
    Type 2 diabetes (T2D) patients on metformin were randomized 3 : 1 : 1 to seven dulaglutide doses, sitagliptin (100 mg), or placebo.

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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