Trial reportDiabetes, obesity & metabolism2025

Efficacy and safety of a fixed-dose combination of dapagliflozin and linagliptin (AJU-A51) in patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, parallel-group, placebo-controlled phase III study.

Jun Hwa Hong, Myung Jin Kim, Kyung Wan Min, Jong Chul Won, Tae Nyun Kim, Byung-Wan Lee, Jun Goo Kang, Jae Hyeon Kim, Jung Hwan Park, Bon Jeong Ku and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2025. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It is linked to trial NCT06329674 (Evaluate the Efficacy and Safety of the Combination of A51R3 and AJU-A51 Compared With the Combination of A51R3 and A51R2 in Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 3 papers.

1number the graph read from it
1cell of the map it votes in
3citing papers in PubMed
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.

← favours the treatmentfavours the comparator →
-1.070 · no effect
Glycemic controlfavours the treatment · against placebo · t2dfeeds one cell of the map
Δ -0.88-1.07 to -0.68p < 0.0001
RESULTS: AJU-A51 significantly reduced HbA1c levels (from 7.93% ± 0.82% to 7.11% ± 0.61%) compared with linagliptin plus placebo (from 7.80% ± 0.71% to 7.87% ± 0.94%), with a least squares mean difference of -0.88% (95% confidence interval -1.07 to -0.68; p < 0.0001) at 24 weeks.

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.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2025
Δ -0.88-1.07 to -0.68
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
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.

NCT06329674 phase3completednot on this map

Evaluate the Efficacy and Safety of the Combination of A51R3 and AJU-A51 Compared With the Combination of A51R3 and A51R2 in Patients With Type 2 Diabetes Mellitus

TypeinterventionalSponsorAJU Pharm Co., Ltd.Ran2021 to 2023Enrolled235ConditionsType2 DiabetesArmsAJU-A51, A51R2, A51R3, AJU-A51 Placebo, A51R2 Placebo
5 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
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.

Jun Hwa Hong *Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Daejeon, Korea.
Myung Jin Kim *Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Kyung Wan MinDepartment of Internal Medicine, Eulji University School of Medicine, Seoul, Korea.
Jong Chul WonDepartment of Internal Medicine, Sanggye Paik Hospital, Cardiovascular and Metabolic Disease Center, Inje University College of Medicine, Seoul, Korea.
Tae Nyun KimDepartment of Internal Medicine, Cardiovascular and Metabolic Disease Center, Inje University College of Medicine, Busan, Korea.
Byung-Wan LeeDivision of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-9899-4992
Jun Goo KangDepartment of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
Jae Hyeon KimDepartment of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID 0000-0001-5001-963X
Jung Hwan ParkDepartment of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
Bon Jeong KuDepartment of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
Chang Beom LeeDivision of Endocrinology and Metabolism, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.ORCID 0000-0003-4891-834X
Sang Yong KimDepartment of Internal Medicine, Chosun University Hospital, Chosun University College of Medicine, Gwangju, Korea.
Ho Sang ShonDepartment of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
Woo Je LeeDepartment of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID 0000-0002-9605-9693
Joong-Yeol ParkDepartment of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Funding

AJUPHARM Co. Ltd., Seoul, Republic of Korea 20DM30203
8 · The paper itself

Abstract

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

aimsTo evaluate the efficacy and safety of add-on dapagliflozin in patients with type 2 diabetes mellitus (T2D) who had inadequate glycaemic control with metformin and linagliptin. MATERIALS AND

methodsA total of 235 patients with inadequate response to metformin (≥1000 mg/day) plus linagliptin (5 mg/day) were randomized to receive either dapagliflozin/linagliptin fixed-dose combination (FDC [AJU-A51]) 10/5 mg/day (n = 117) or linagliptin 5 mg plus placebo (n = 118) for 24 weeks. After the main treatment period, patients who received linagliptin plus placebo were treated with AJU-A51 for an additional 28 weeks. Change in glycated haemoglobin (HbA1c) from baseline to Week 24 was the primary endpoint.

resultsAJU-A51 significantly reduced HbA1c levels (from 7.93% ± 0.82% to 7.11% ± 0.61%) compared with linagliptin plus placebo (from 7.80% ± 0.71% to 7.87% ± 0.94%), with a least squares mean difference of -0.88% (95% confidence interval -1.07 to -0.68; p < 0.0001) at 24 weeks. The AJU-A51 group had a significantly higher proportion of patients who achieved HbA1c <7.0% at Week 24 than the control group (44.8% vs. 18.6%; p < 0.001). The AJU-A51 group maintained glycaemic efficacy up to 52 weeks, whereas the control group showed a substantial reduction in HbA1c after switching to AJU-A51 in the extension study period. Both groups had similar incidence of treatment-emergent and serious adverse events, and no cases of symptomatic hypoglycaemia were reported.

conclusionsDapagliflozin and linagliptin FDC (AJU-A51) showed potent glucose-lowering effects, with good tolerability, in patients with T2D who had poor glycaemic control on metformin and linagliptin (ClinicalTrials.gov [NCT06329674]).

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesGlycated HemoglobinHypoglycemic AgentsLinagliptinMetforminAdultAgedBlood GlucoseDouble-Blind MethodDrug CombinationsDrug Therapy, CombinationFemaleHumansMaleBenzhydryl CompoundsBlood GlucosedapagliflozinDrug CombinationsGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsLinagliptinMetformindapagliflozinlinagliptinrandomized controlled trialSGLT2 inhibitortype 2 diabetes

Identifiers

PMID39375869
PMCPMC11618241

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.