Evidence map›Paper›PMID 24842985›Full record

Trial reportDiabetes care2014

Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).

Guillermo Umpierrez, Santiago Tofé Povedano, Federico Pérez Manghi, Linda Shurzinske, Valeria Pechtner

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes care, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03590626 (Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease), which is not on this map. Cited by 164 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
164citing papers in PubMed, 21 pooled it
25.3field-weighted citation impact, top 1% of its field
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.

NCT03590626 nacompletedstarted 2019, after this paper: background citation

Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial

Ran2019Enrolled60Registered outcomes7Posted comparisons0ConditionsNon Alcoholic Fatty Liver Disease, Type2 Diabetes MellitusArmsDulaglutide
PMID 27732328PMID 24742660PMID 26089386PMID 25018121PMID 27916783PMID 22554256PMID 25482832PMID 23383649PMID 22431131PMID 22025886other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

164 citing papers in PubMed, 21 syntheses or guidelines pooled it, 329 citations in OpenAlex.

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  11. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  12. Metformin monotherapy for adults with type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2020 · on this map
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104 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

5 authors at 3 institutions in 2 countries.

Guillermo UmpierrezDivision of Endocrinology, Emory University School of Medicine, Atlanta, GA.
Santiago Tofé PovedanoEndocrinología, Clínica Juaneda, Palma de Mallorca, Spain.
Federico Pérez ManghiCentro de Investigaciones Metabólicas, Buenos Aires, Argentina.
Linda ShurzinskeLilly Diabetes, Eli Lilly and Company, Indianapolis, IN.
Valeria PechtnerLilly Diabetes, Eli Lilly and Company, Neuilly-sur-Seine Cedex, France pechtner_valeria@lilly.com.
Eli Lilly (United States) · USCentro de Investigaciones Cardiovasculares · AREmory University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveCompare the efficacy and safety of monotherapy with dulaglutide, a once-weekly GLP-1 receptor agonist, to metformin-treated patients with type 2 diabetes. The primary objective compared dulaglutide 1.5 mg and metformin on change from baseline glycosylated hemoglobin A1c (HbA1c) at 26 weeks. RESEARCH DESIGN AND

methodsThis 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin. Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.

resultsAt 26 weeks, changes from baseline HbA1c (least squares [LS] mean ± SE) were: dulaglutide 1.5 mg, -0.78 ± 0.06% (-8.5 ± 0.70 mmol/mol); dulaglutide 0.75 mg, -0.71 ± 0.06% (-7.8 ± 0.70 mmol/mol); and metformin, -0.56 ± 0.06% (-6.1 ± 0.70 mmol/mol). Dulaglutide 1.5 and 0.75 mg were superior to metformin (LS mean difference): -0.22% (-2.4 mmol/mol) and -0.15% (-1.6 mmol/mol) (one-sided P < 0.025, both comparisons), respectively. Greater percentages reached HbA1c targets <7.0% (<53 mmol/mol) and ≤6.5% (≤48 mmol/mol) with dulaglutide 1.5 and 0.75 mg compared with metformin (P < 0.05, all comparisons). No severe hypoglycemia was reported. Compared with metformin, decrease in weight was similar with dulaglutide 1.5 mg and smaller with dulaglutide 0.75 mg. Over 52 weeks, nausea, diarrhea, and vomiting were the most common adverse events; incidences were similar between dulaglutide and metformin.

conclusionsDulaglutide improves glycemic control and is well tolerated as monotherapy in patients with early stage type 2 diabetes.

Indexed as

AdultAgedBlood GlucoseBody WeightDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemic AgentsImmunoglobulin Fc FragmentsMaleMetforminMiddle AgedRecombinant Fusion ProteinsBlood GlucosedulaglutideGlucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsImmunoglobulin Fc FragmentsMetforminRecombinant Fusion Proteins

Identifiers

PMID24842985
OpenAlexW2030546890

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

Registered trials

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.