Trial reportDiabetes & metabolism journal2023

Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension.

Jun Sung Moon, Il Rae Park, Hae Jin Kim, Choon Hee Chung, Kyu Chang Won, Kyung Ah Han, Cheol-Young Park, Jong Chul Won, Dong Jun Kim, Gwan Pyo Koh and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Diabetes & metabolism journal, 2023. The graph read 4 numbers from its abstract, feeding 3 cells of the map: it supports the treatment in 3. It reports registered trial NCT04170998. Cited by 2 papers, 2 of them syntheses that pooled it.

4numbers the graph read from it
3cells of the map it votes in
2citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 17% 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.

← favours the treatmentfavours the comparator →
-0.7916.20 · no effect
HbA1c reduction at week 52evogliptin add-on to DAPA/MET therapy vs placebofavours the treatment · t2dfeeds 3 cells of the map
Δ -0.55-0.71 to -0.39<0.0001
RESULTS: Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, -0.65% and -0.55%; 95% confidence interval [CI], -0.79 to -0.51 and -0.71 to -0.39; P<0.0001).
HbA1c reduction at week 24evogliptin add-on to DAPA/MET therapy vs placebofavours the treatment · t2dfeeds 3 cells of the map
Δ -0.65-0.79 to -0.51<0.0001
RESULTS: Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, -0.65% and -0.55%; 95% confidence interval [CI], -0.79 to -0.51 and -0.71 to -0.39; P<0.0001).
Homeostatic model assessment of β-cell functionevogliptinfavours the comparator · t2dfeeds one cell of the map
Δ 9.041.86 to 16.2P=0.0138
Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138).
Glycemic controlfavours the treatment · against placebo · t2dfeeds 2 cells of the map
Δ -0.55-0.79 to -0.51P<0.0001
RESULTS: Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, -0.65% and -0.55%; 95% confidence interval [CI], -0.79 to -0.51 and -0.71 to -0.39; P<0.0001).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

DPP-4 inhibitors×glycemic control

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 59 favour the treatment, 19 find no difference, 24 favour the comparator.

Belief with this paper
0.82replicated · 56 families support, 12 contradict · against placebo
Without it
0.82This paper does not move the number. It would be established.
← favours the treatmentfavours the comparator →
0 · no effect
This paper283 enrolled · 2020
Δ -0.55-0.79 to -0.51
NCT015282542,004 enrolled · 2012
Slope -0.02-0.05 to 0.00
NCT026078651,864 enrolled · 2016
Δ -0.50-0.60 to -0.40
NCT001216671,462 enrolled · 2005
Δ -0.73-0.92 to -0.53
NCT040178321,441 enrolled · 2019
Δ -0.20-0.30 to -0.10
NCT011066771,284 enrolled · 2010
Δ -0.62-0.76 to -0.48
NCT016060071,282 enrolled · 2012
Δ -0.27-0.48 to -0.05
NCT004827291,246 enrolled · 2007
Δ -0.60-0.78 to -0.43
NCT020991101,233 enrolled · 2014
Δ -0.46-0.63 to -0.30
NCT019301881,231 enrolled · 2013
Δ -1.06-1.21 to -0.91
NCT007344741,202 enrolled · 2008
Δ -0.71-0.87 to -0.55
NCT022730501,136 enrolled · 2014
Δ -0.21-0.41 to -0.02
NCT004499301,050 enrolled · 2007
Δ 0.140.06 to 0.21

SGLT2 inhibitors×glycemic control

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 81 favour the treatment, 11 find no difference, 4 favour the comparator.

Belief with this paper
0.92replicated · 70 families support, 6 contradict · against placebo
Without it
0.92This paper does not move the number. It would be established.
← favours the treatmentfavours the comparator →
0 · no effect
This paper283 enrolled · 2020
Δ -0.55-0.79 to -0.51
NCT010326294,330 enrolled · 2009
Δ 2.79-1.57 to 7.15
NCT011374742,996 enrolled · 2010
Δ -0.46-0.59 to -0.33
NCT011956622,245 enrolled · 2010
Δ -0.61-0.76 to -0.46
NCT010956661,484 enrolled · 2010
Δ -0.59-0.76 to -0.42
NCT009688121,452 enrolled · 2009
Δ -0.01-0.11 to 0.09
NCT017190031,413 enrolled · 2012
Adjusted mean -0.33-0.56 to -0.10
NCT011066771,284 enrolled · 2010
Δ -0.62-0.76 to -0.48
NCT016060071,282 enrolled · 2012
Δ -0.59-0.81 to -0.37
NCT006732311,240 enrolled · 2008
Δ -0.45-0.59 to -0.31
NCT020991101,233 enrolled · 2014
Δ -0.43-0.60 to -0.27
NCT006609071,217 enrolled · 2008
Δ 0.00-0.11 to 0.11
NCT018093271,186 enrolled · 2013
Δ -0.46-0.66 to -0.27

Metformin×glycemic control

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 41 favour the treatment, 12 find no difference, 8 favour the comparator.

Belief with this paper
0.84replicated · 32 families support, 6 contradict · against placebo
Without it
0.84This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper283 enrolled · 2020
Δ -0.65-0.79 to -0.51
NCT017190031,413 enrolled · 2012
Adjusted mean -0.72-0.95 to -0.48
NCT018093271,186 enrolled · 2013
Δ -0.40-0.59 to -0.21
NCT022730501,136 enrolled · 2014
Δ -0.89-1.08 to -0.69
NCT008598981,093 enrolled · 2009
Δ -0.53-0.74 to -0.32
Δ -0.85-43.8 to 26.7
NCT00643851994 enrolled · 2008
Δ -0.86-1.11 to -0.62
NCT01708902876 enrolled · 2012
Δ -1.00-1.23 to -0.78
NCT00676338820 enrolled · 2008
Δ -0.05-0.26 to 0.17
NCT01126580807 enrolled · 2010
Δ -0.22-0.36 to -0.08
NCT01023581784 enrolled · 2009
Δ -0.67-0.96 to -0.37
NCT01076088744 enrolled · 2010
Δ -0.84-1.15 to -0.52
NCT00386100688 enrolled · 2006
Δ -0.49-0.67 to -0.30
4 · 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.

NCT04170998 phase3completed

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Ran2020Enrolled283Registered outcomes4Posted comparisons0ConditionsType2 DiabetesArmsDapagliflozin 10mg, Evogliptin 5mg, Evogliptin Placebo, Metformin ≥ 1000mg
Open the trial in the graph
5 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Guideline
  2. Pooled it
6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

15 authors at 13 institutions in 3 countries.

Jun Sung Moon *Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Il Rae Park *Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Hae Jin KimDepartment of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
Choon Hee ChungDepartment of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea.
Kyu Chang WonDepartment of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Kyung Ah HanDepartment of Internal Medicine, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.
Cheol-Young ParkDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Jong Chul WonDepartment of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea.
Dong Jun KimDepartment of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.
Gwan Pyo KohDepartment of Internal Medicine, Jeju National University College of Medicine, Jeju, Korea.
Eun Sook KimDepartment of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
Jae Myung YuDepartment of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea.
Eun-Gyoung HongDepartment of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.
Chang Beom LeeDepartment of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
Kun-Ho YoonDepartment of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Yeungnam University CollegeAjou University · KREulji University · KRHallym University Dongtan Sacred Heart Hospital · KRHallym University Kangnam Sacred Heart Hospital · KRHanyang University Guri Hospital · KRInje University Ilsan Paik Hospital · KRInje University Sanggye Paik Hospital · KRKangbuk Samsung Hospital · KRNew Generation University College · ETThe Catholic University of Korea Seoul St. Mary's Hospital · KRUlsan College · KRYonsei University · KR

Funding

Dong-A ST Co. Ltd.
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgruoundThis study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.

methodsIn this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).

resultsEvogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, -0.65% and -0.55%; 95% confidence interval [CI], -0.79 to -0.51 and -0.71 to -0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.

conclusionLong-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.

Indexed as

Diabetes Mellitus, Type 2MetforminBenzhydryl CompoundsDrug Therapy, CombinationGlucoseGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsPiperazines4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-oneBenzhydryl CompoundsdapagliflozinGlucoseGlucosidesGlycated HemoglobinHypoglycemic AgentsMetforminPiperazinesDapagliflozinDiabetes mellitus, type 2Dipeptidyl-peptidase IV inhibitorsDrug therapy, combinationMetformin

Identifiers

PMID37750183
PMCPMC10695708
OpenAlexW4387032773

What Socratic holds

Texttitle and abstract
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.