Evidence map›Paper›PMID 25425451›Full record

Trial reportDiabetes, obesity & metabolism2015

Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT): a randomized trial.

M A Abdul-Ghani, C Puckett, C Triplitt, D Maggs, J Adams, E Cersosimo, R A DeFronzo

3 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 83 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 2 pooled it
11.4field-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.

NCT02613897 nacompletedstarted 2016, after this paper: background citation

A 16-wk, Uni-center, Randomized, Double-blind, Parallel, Phase 3b Trial to Evaluate Efficacy of Saxagliptin + Dapagliflozin vs.Dapagliflozin With Regard to EGP in T2DM With Insufficient Glycemic Control on Metformin+/-Sulfonylurea Therapy

Ran2016Enrolled56Registered outcomes9Posted comparisons0ConditionsDiabetes Mellitus, Type 2Armsdapagliflozin, Placebo, Saxagliptin
PMID 24463448PMID 9742977PMID 21781152PMID 18726829PMID 21114605PMID 24947443PMID 17244786PMID 15277443PMID 15549021PMID 17613449PMID 17876024PMID 17934153other papers from this trial
Open the trial in the graph
NCT03658031 phase3unknown statusstarted 2019, after this paper: background citation

Effect of Dapagliflozin on the Progression From Prediabetes to T2DM in Subjects With Myocardial Infarction

Ran2019Enrolled576Registered outcomes1Posted comparisons0ConditionsCVD, Myocardial Infarction, Prediabetes, T2DM (Type 2 Diabetes Mellitus)ArmsDapagliflozin 10mg
PMID 28096223PMID 28428225PMID 27679584PMID 27814267PMID 24631482PMID 23668478PMID 19490820PMID 17315136PMID 25739882PMID 28615237PMID 29227578PMID 16644654other papers from this trial
Open the trial in the graph
NCT02946632 phase3unknown statusnot on this mapstarted 2016, after this paper: background citation

Effectiveness and Tolerability of Novel, Initial Triple Combination Therapy With Xigduo (Dapagliflozin Plus Metformin) and Saxagliptin vs. Conventional Stepwise add-on Therapy in Drug-naïve Patients With Type 2 Diabetes

TypeinterventionalSponsorKorea University Anam HospitalRan2016 to 2019Enrolled104ConditionsDiabetes Mellitus, Type IIArmstriple combination therapy, Stepwise add-on therapy
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 2 syntheses or guidelines pooled it, 196 citations in OpenAlex.

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23 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

7 authors at 3 institutions in 1 country.

M A Abdul-GhaniDiabetes Division, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
C Puckett
C Triplitt
D Maggs
J Adams
E Cersosimo
R A DeFronzo
Texas Diabetes Institute · USThe University of Texas Health Science Center at San Antonio · USGI Dynamics (United States) · US

Funding

NIDDK NIH HHS R01 DK103841
6 · The paper itself

Abstract

aimTo test our hypothesis that initiating therapy with a combination of agents known to improve insulin secretion and insulin sensitivity in subjects with new-onset diabetes would produce greater, more durable reduction in glycated haemoglobin (HbA1c) levels, while avoiding hypoglycaemia and weight gain, compared with sequential addition of agents that lower plasma glucose but do not correct established pathophysiological abnormalities.

methodsDrug-naïve, recently diagnosed subjects with type 2 diabetes mellitus (T2DM) were randomized in an open-fashion design in a single-centre study to metformin/pioglitazone/exenatide (triple therapy; n = 106) or an escalating dose of metformin followed by sequential addition of sulfonylurea and glargine insulin (conventional therapy; n = 115) to maintain HbA1c levels at <6.5% for 2 years.

resultsParticipants receiving triple therapy experienced a significantly greater reduction in HbA1c level than those receiving conventional therapy (5.95 vs. 6.50%; p < 0.001). Despite lower HbA1c values, participants receiving triple therapy experienced a 7.5-fold lower rate of hypoglycaemia compared with participants receiving conventional therapy. Participants receiving triple therapy experienced a mean weight loss of 1.2 kg versus a mean weight gain of 4.1 kg (p < 0.01) in those receiving conventional therapy.

conclusionThe results of this exploratory study show that combination therapy with metformin/pioglitazone/exenatide in patients with newly diagnosed T2DM is more effective and results in fewer hypoglycaemic events than sequential add-on therapy with metformin, sulfonylurea and then basal insulin.

Indexed as

Diabetes Mellitus, Type 2Drug Therapy, CombinationExenatideFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin ResistanceMaleMetforminMiddle AgedPeptidesPioglitazoneThiazolidinedionesVenomsExenatideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminPeptidesPioglitazoneThiazolidinedionesVenomscombination therapyconventional therapydurabilityglycaemic control

Identifiers

PMID25425451
PMCPMC5577982
OpenAlexW2060716197

What Socratic holds

Texttitle and abstract
LicenceTDM
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.