Evidence map›Paper›PMID 26799540›Full record

Trial reportDiabetes, obesity & metabolism2016

A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8).

K M Dungan, R Weitgasser, F Perez Manghi, E Pintilei, J L Fahrbach, H H Jiang, J Shell, K E Robertson

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 8 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

53 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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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

8 authors.

K M DunganDivision of Endocrinology, Diabetes and Metabolism, Ohio State University, Columbus, OH, USA.
R WeitgasserDepartment of Internal Medicine, Wehrle-Diakonissen Hospital, Salzburg, Austria.
F Perez ManghiCentro de Investigaciones Metabólicas (CINME), Buenos Aires, Argentina.
E PintileiDepartment of Medicine, SC Consultmed SRL, Iasi, Romania.
J L FahrbachLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
H H JiangLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
J ShellLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
K E RobertsonLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo evaluate the safety and efficacy of once-weekly dulaglutide 1.5 mg, a long-acting glucagon-like peptide-1 receptor agonist, compared with placebo in patients with type 2 diabetes (T2D) on glimepiride monotherapy.

methodsThis phase III, randomized (4 : 1; dulaglutide:placebo), double-blind, placebo-controlled, 24-week study compared the safety and efficacy of once-weekly dulaglutide 1.5 mg with placebo in sulphonylurea-treated (≥half-maximal dose, stable ≥3 months) patients (N = 300) with T2D and inadequate glycaemic control [glycated haemoglobin (HbA1c) ≥7.5 and ≤9.5% (≥58 mmol/mol and ≤80 mmol/mol)]. Analysis was carried out according to intention-to-treat.

resultsAt baseline, the mean participant age was 58 years; mean HbA1c was 8.4% (68 mmol/mol) and mean weight was 85.5 kg. Dulaglutide 1.5 mg was superior to placebo at 24 weeks for HbA1c reduction from baseline with a between-group HbA1c difference of -1.3% [95% confidence interval (CI) -1.6, -1.0] or -14 mmol/mol (95% CI -17, -11); p < 0.001. A greater proportion of participants in the dulaglutide group reached an HbA1c level of <7.0% (53 mmol/mol) compared with placebo (55.3% vs 18.9%; p < 0.001). Dulaglutide significantly decreased fasting serum glucose from baseline compared with placebo (between-group difference -1.86 mmol/l (95% CI -2.58, -1.14) or -33.54 mg/dl (95% CI -46.55, -20.53); p < 0.001. Weight was decreased significantly from baseline in the dulaglutide group (p < 0.001); the between-group difference was not significant. The most common treatment-emergent adverse events for dulaglutide 1.5 mg were gastrointestinal: nausea (10.5%), diarrhoea (8.4%) and eructation (5.9%). Total hypoglycaemia was higher with dulaglutide 1.5 mg vs placebo (2.37 and 0.07 events/participant/year, respectively; p = 0.025). No severe hypoglycaemia was reported.

conclusionsOnce-weekly dulaglutide 1.5 mg had a favourable benefit/risk profile when added to glimepiride monotherapy.

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAgedDiabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleDrug ResistanceDrug Therapy, CombinationFemaleGlucagon-Like Peptide-1 ReceptorGlucagon-Like PeptidesGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsImmunoglobulin Fc FragmentsdulaglutideglimepirideGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsSulfonylurea Compoundsdulaglutideglucagon-like peptide-1type 2 diabetes

Identifiers

PMID26799540
PMCPMC5067625

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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.