Evidence map›Paper›PMID 29473704›Full record

Trial reportDiabetes, obesity & metabolism2018

Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study.

Cristian Guja, Juan P Frías, Aniko Somogyi, Serge Jabbour, Hui Wang, Elise Hardy, Julio Rosenstock

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02229383 (A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin), which is not on this map. Cited by 33 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 9 pooled it
5.2field-weighted citation impact, top 3% 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.

NCT02229383 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin

TypeinterventionalSponsorAstraZenecaRan2014 to 2016Enrolled464ConditionsDiabetes MellitusArmsExenatide, Exenatide matching placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 9 syntheses or guidelines pooled it, 75 citations in OpenAlex.

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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

7 authors at 6 institutions in 3 countries.

Cristian GujaDepartment of Diabetes, Nutrition and Metabolic Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.ORCID 0000-0002-8703-0522
Juan P FríasNational Research Institute, Los Angeles, California.ORCID 0000-0001-9486-1255
Aniko Somogyi2nd Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
Serge JabbourDivision of Endocrinology, Diabetes & Metabolic Diseases, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.ORCID 0000-0002-4080-0470
Hui WangAstraZeneca, Gaithersburg, Maryland.
Elise HardyAstraZeneca, Gaithersburg, Maryland.
Julio RosenstockDallas Diabetes Research Center at Medical City, Dallas, Texas.ORCID 0000-0001-8324-3275
AstraZeneca (United States) · USCarol Davila University of Medicine and Pharmacy · RODallas Diabetes Research Center · USNational Research Institute · USSemmelweis University · HUThomas Jefferson University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the efficacy and safety of adding the glucagon-like peptide-1 receptor agonist exenatide once weekly (QW) 2 mg or placebo among patients with type 2 diabetes who were inadequately controlled despite titrated insulin glargine (IG) ± metformin.

methodsThis multicentre, double-blind study (ClinicalTrials.gov identifier: NCT02229383) randomized (1:1) patients with persistent hyperglycaemia after an 8-week titration phase (glycated haemoglobin [HbA1c] 7.0%-10.5% [53-91 mmol/mol]) to exenatide QW or placebo. The primary endpoint was HbA1c change from baseline to week 28. Secondary endpoints included body weight, 2-hour postprandial glucose, and mean daily IG dose.

resultsOf 464 randomized patients (mean: age, 58 years; HbA1c, 8.5% [69 mmol/mol]; diabetes duration, 11.3 years), 91% completed 28 weeks. Exenatide QW + IG vs placebo + IG significantly reduced HbA1c (least-squares mean difference, -0.73% [-8.0 mmol/mol]; 95% confidence interval, -0.93%, -0.53% [-10.2, -5.8 mmol/mol]; P < .001; final HbA1c, 7.55% [59 mmol/mol] and 8.24% [67 mmol/mol], respectively); body weight (-1.50 kg; -2.17, -0.84; P < .001); and 2-hour postprandial glucose (-1.52 mmol/L [-27.5 mg/dL]; -2.15, -0.90 [-38.7, -16.2]; P < .001). Significantly more exenatide QW + IG-treated patients vs placebo + IG-treated patients reached HbA1c <7.0% (<53 mmol/mol) (32.5% vs 7.4%; P < .001); daily IG dose increased by 2 and 4 units, respectively. Gastrointestinal and injection-site adverse events were more frequent with exenatide QW + IG (15.1% and 7.8%, respectively) than with placebo + IG (10.8% and 3.0%, respectively); hypoglycaemia incidence was similar between the exenatide QW + IG (29.7%) and placebo + IG (29.0%) groups, with no major hypoglycaemic events.

conclusionsAmong patients with inadequate glycaemic control, exenatide QW significantly improved glucose control and decreased body weight, without increased hypoglycaemia or unexpected safety findings.

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAgedBody Mass IndexDiabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleDrug MonitoringDrug Therapy, CombinationExenatideFemaleFollow-Up StudiesGlucagon-Like Peptide-1 ReceptorGlycated HemoglobinHumansHyperglycemiaHypoglycemiaExenatideGLP1R protein, humanGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsIncretinsInsulin Glargineexenatide once weeklyglucagon-like peptide-1 receptor agonistinsulin glarginetype 2 diabetes

Identifiers

PMID29473704
PMCPMC6032936
OpenAlexW2791169690

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.