Evidence map›Paper›PMID 26089386›Full record

Trial reportDiabetes care2015

Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).

Francesco Giorgino, Marian Benroubi, Jui-Hung Sun, Alan G Zimmermann, Valeria Pechtner

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes care, 2015. 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 126 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
126citing papers in PubMed, 19 pooled it
21.5field-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 24842985PMID 24742660PMID 25018121PMID 27916783PMID 22431131PMID 22025886PMID 22554256PMID 23383649PMID 25482832other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

126 citing papers in PubMed, 19 syntheses or guidelines pooled it, 256 citations in OpenAlex.

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66 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 4 institutions in 4 countries.

Francesco GiorginoUniversity of Bari Aldo Moro, Bari, Italy.
Marian BenroubiEvangelismos-Polyclinic, Athens General Hospital, Athens, Greece.
Jui-Hung SunChang Gung Memorial Hospital, Taoyuan Hsien, Taiwan.
Alan G ZimmermannEli Lilly and Company, Indianapolis, IN.
Valeria PechtnerEli Lilly and Company, Neuilly-Sur-Seine Cedex, France pechtner_valeria@lilly.com.
Eli Lilly (United States) · USPolyclinic General Hospital · GRTaoyuan Chang Gung Memorial Hospital · TWUniversity of Bari Aldo Moro · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes. The primary objective was noninferiority of dulaglutide 1.5 mg to glargine in the HbA1c change from baseline at 52 weeks. RESEARCH DESIGN AND

methodsIn this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine.

resultsThe baseline mean ± SD HbA1c was 8.1 ± 1.0% (65.5 ± 10.8 mmol/mol). The least squares mean ± SE HbA1c change from baseline to the primary end point was -1.08 ± 0.06% (-11.8 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, -0.76 ± 0.06% (-8.3 ± 0.7 mmol/mol) for dulaglutide 0.75 mg, and -0.63 ± 0.06% (-6.9 ± 0.7 mmol/mol) for glargine, with an end point mean ± SD dose of 29 ± 26 units (0.33 ± 0.24 units/kg), and a fasting plasma glucose (mean ± SD) of 118 ± 23 mg/dL from self-monitored plasma glucose. Statistical criteria for superiority were met with dulaglutide 1.5 mg and for noninferiority with dulaglutide 0.75 mg. More patients on dulaglutide 1.5 mg achieved HbA1c targets <7.0% (53 mmol/mol) versus glargine (P < 0.001). Body weight decreased with dulaglutide and increased with glargine. Total hypoglycemia rates were lower with dulaglutide; severe hypoglycemia was minimal. Increases in pancreatic enzymes were observed for dulaglutide. Incidence of nausea (15.4, 7.7, and 1.5%) and diarrhea (10.6, 9.2, and 5.7%) were more common with dulaglutide 1.5 mg and 0.75 mg than with glargine.

conclusionsOnce-weekly dulaglutide 1.5 mg, compared with daily insulin glargine without forced titration, demonstrated greater HbA1c reduction and weight loss, with a higher incidence of gastrointestinal adverse events and a lower risk of hypoglycemia.

Indexed as

AgedBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodFemaleGastrointestinal DiseasesGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsImmunoglobulin Fc FragmentsInsulin GlargineMaleMetforminMiddle AgedBlood GlucosedulaglutideglimepirideGlucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsImmunoglobulin Fc FragmentsInsulin GlargineMetforminRecombinant Fusion ProteinsSulfonylurea Compounds

Identifiers

PMID26089386
OpenAlexW906438903

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.