Evidence map›Paper›PMID 25912221›Full record

Trial reportDiabetes, obesity & metabolism2015

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.

R S Weinstock, B Guerci, G Umpierrez, M A Nauck, Z Skrivanek, Z Milicevic

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 15 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 15 syntheses or guidelines pooled it.

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9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

R S WeinstockEndocrinology, Diabetes and Metabolism, Upstate Medical University, Syracuse, NY, USA.
B GuerciDiabetology, Metabolic Disease and Nutrition, University of Lorraine, CIC Inserm ILCV, CHU, Nancy, France.
G UmpierrezDiabetes & Endocrinology, Emory University, Atlanta, GA, USA.
M A NauckDiabeteszentrum Bad Lauterberg, Bad Lauterberg, Germany.
Z SkrivanekLilly Research Laboratories, Indianapolis, IN, USA.
Z MilicevicLilly Research Laboratories, Vienna, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the once-weekly glucagon-like peptide-1 (GLP-1) receptor dulaglutide with the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin after 104 weeks of treatment.

methodsThis 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. Change in glycated haemoglobin (HbA1c) concentration from baseline was the primary efficacy measure. A total of 1098 participants with HbA1c concentrations ≥7.0% (≥53.0 mmol/mol) and ≤9.5% (≤80.3 mmol/mol) were randomized, and 657 (59.8%) completed the study. We report results for dulaglutide and sitagliptin at the final endpoint.

resultsChanges 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). 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). 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). Pancreatic, thyroid, cardiovascular and hypersensitivity safety were similar across groups.

conclusionsDulaglutide doses provided superior glycaemic control and dulaglutide 1.5 mg resulted in greater weight reduction versus sitagliptin at 104 weeks, with acceptable safety.

Indexed as

Blood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemic AgentsImmunoglobulin Fc FragmentsMaleMetforminMiddle AgedRecombinant Fusion ProteinsSitagliptin PhosphateBlood GlucosedulaglutideGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsImmunoglobulin Fc FragmentsMetforminRecombinant Fusion ProteinsSitagliptin Phosphatediabetesdulaglutidesitagliptin

Identifiers

PMID25912221
PMCPMC5008205

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.