Evidence map›Paper›PMID 27651331›Full record

Trial reportThe lancet. Diabetes & endocrinology2016

Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial.

Juan P Frías, Cristian Guja, Elise Hardy, Azazuddin Ahmed, Fang Dong, Peter Öhman, Serge A Jabbour

Erratum issued 4 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The lancet. Diabetes & endocrinology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT02597049. Cited by 188 papers, 22 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
188citing papers in PubMed, 22 pooled it
39.9field-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.

NCT02597049 phase3completed

A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Ran2015Enrolled424Registered outcomes11Posted comparisons32ConditionsType 2 Diabetes MellitusArmsDulaglutide, Metformin, Placebo, SGLT2 inhibitor
Open the trial in the graph
NCT03361098 phase4completedstarted 2017, after this paper: background citation

Combined Effects of SGLT2 Inhibition and GLP-1 Receptor Agonism on Food Intake, Body Weight and Central Satiety and Reward Circuits in Obese T2DM Patients

Ran2017Enrolled65Registered outcomes18Posted comparisons0ConditionsObesity, Type 2 Diabetes MellitusArmsDapagliflozin 10mg, exenatide, placebo dapagliflozin, placebo exenatide
PMID 26769912PMID 24463454PMID 25943756PMID 25071023PMID 24323912PMID 22402735PMID 22332246PMID 26403227PMID 26385462PMID 26331843PMID 26180105PMID 26094857other papers from this trial
Open the trial in the graph
NCT03419624 phase3terminatedstarted 2018, after this paper: background citation

A 28-week, Multi-center Randomized, Double-blind, Placebo-controlled Study to Evaluate the Potential of Dapagliflozin Plus Exenatide in Combination With High-dose Intensive Insulin Therapy Compared to Placebo in Obese Insulin-resistant Patients With Type 2 Diabetes Mellitus (Proof-of-concept Study)

Ran2018Enrolled13Registered outcomes7Posted comparisons0ConditionsDiabetes Mellitus, Type 2, ObesityArmsDapagliflozin 10mg, Exenatide 2 mg [Bydureon], Insulin, Metformin, if taken before, Placebo injection
PMID 18613325PMID 22431673PMID 26213556PMID 25436106PMID 24741511PMID 24251534PMID 22608371PMID 11815510PMID 18165348PMID 20609969PMID 22526604PMID 22517736other papers from this trial
Open the trial in the graph
NCT03878706 recruitingnot on this mapstarted 2017, after this paper: background citation

The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk

Typeobservational_patient_registrySponsorUniversity of AthensRan2017 to 2027Enrolled240ConditionsDiabetes Mellitus, Type 2
3 · Its place in the literature

Who cites it

188 citing papers in PubMed, 22 syntheses or guidelines pooled it, 382 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 2 countries.

Juan P FríasNational Research Institute, Los Angeles, CA, USA. Electronic address: juan.frias@nritrials.com.
Cristian GujaDepartment of Diabetes, Nutrition and Metabolic Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; 1st Clinic of Diabetes, N Paulescu National Institute of Diabetes, Nutrition and Metabolic Diseases, Bucharest, Romania.
Elise HardyAstraZeneca, Gaithersburg, MD, USA.
Azazuddin AhmedApex Medical Research, Chicago, IL, USA; John H Stroger Jr Hospital, Chicago, IL, USA; Rush University Medical Center, Chicago, IL, USA.
Fang DongAstraZeneca, Gaithersburg, MD, USA.
Peter ÖhmanAstraZeneca, Gaithersburg, MD, USA.
Serge A JabbourDivision of Endocrinology, Diabetes & Metabolic Diseases, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA.
AstraZeneca (United States) · USCarol Davila University of Medicine and Pharmacy · ROJohn H. Stroger, Jr. Hospital of Cook County · USNational Research Institute · USThomas Jefferson University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose co-transporter-2 (SGLT2) inhibitors reduce glycaemia and weight, and improve cardiovascular risk factors via different mechanisms. We aimed to compare the efficacy and safety of co-initiation of the GLP-1 receptor agonist exenatide and the SGLT2 inhibitor dapagliflozin with exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled by metformin.

methodsDURATION-8 was a 28 week, multicentre, double-blind, randomised, active-controlled phase 3 trial done at 109 sites in six countries. Adults (aged ≥18 years) with type 2 diabetes and inadequate glycaemic control (HbA

findingsBetween Sept 4, 2014, and Oct 15, 2015, we randomly assigned 695 patients to receive exenatide plus dapagliflozin (n=231), exenatide alone (n=231; n=1 untreated), or dapagliflozin alone (n=233). The intention-to-treat population comprised 685 participants (mean HbA

interpretationCo-initiation of exenatide and dapagliflozin improved various glycaemic measures and cardiovascular risk factors in patients with type 2 diabetes inadequately controlled by metformin monotherapy. The dual treatment regimen was well tolerated, with the expected safety profile for this combination. Additional data from an ongoing study (eg, AWARD-10; NCT02597049) will further inform the use of these drug classes in combination.

fundingAstraZeneca.

Indexed as

AdultAgedBenzhydryl CompoundsDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationExenatideFemaleGlucosidesHumansHypoglycemic AgentsMaleMetforminMiddle AgedPeptidesTreatment FailureBenzhydryl CompoundsdapagliflozinExenatideGlucosidesHypoglycemic AgentsMetforminPeptidesVenoms

Identifiers

PMID27651331
OpenAlexW2519803668

What Socratic 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 Socratic graph.