Trial reportDiabetes & metabolism journal2026

Efficacy and Safety of High-Dose Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial.

Jun Hwa Hong, Kyung Ah Han, You-Cheol Hwang, Eun-Gyoung Hong, Hae Jin Kim, Chang Beom Lee, Ho Chan Cho, Jong Chul Won, Hun-Sung Kim, Eui-Hyun Kim and 3 more

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

Trial report in Diabetes & metabolism journal, 2026. 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 NCT05296044 (This Study Evaluates the Addition of Dapagliflozin in the Treatment of Type 2 Diates With Metformin and JT-003 Combination Therapy.), which is not on this map. Cited by 2 papers.

1number the graph read from it
1cell of the map it votes in
2citing 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 →
-0.800 · no effect
HbA1cpioglitazone 30 mg/day add-on vs placebofavours the treatment · t2dfeeds one cell of the map
Δ -0.80<0.0001
RESULTS: The HbA1c after 24 weeks treatment reduced from 7.8%±0.8% to 7.0%±0.6% (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.

Thiazolidinediones×glycemic control

SupportsOpen on the map →What to test next →

16 readable studies in this cell: 9 favour the treatment, 4 find no difference, 3 favour the comparator.

Belief with this paper
0.83established · 5 families support, 1 contradict · against placebo
Without it
0.80This paper moves it by +0.03.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2026
Δ -0.80
NCT00676338820 enrolled · 2008
Δ 0.10-0.15 to 0.35
NCT00839527685 enrolled · 2009
Δ 0.250.10 to 0.40
NCT00727857600 enrolled · 2007
Δ 0.840.50 to 1.18
NCT01076075427 enrolled · 2010
Δ -0.68-0.87 to -0.50
NCT00770653305 enrolled · 2007
Δ 0.16-0.02 to 0.33
NCT0158944577 enrolled · 2008
Δ -0.74-7.90 to 8.00
NCT0031865623 enrolled · 2005
Δ 5.02-0.32 to 10.4
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.

NCT05296044 phase3unknown statusnot on this map

This Study Evaluates the Addition of Dapagliflozin in the Treatment of Type 2 Diates With Metformin and JT-003 Combination Therapy.

TypeinterventionalSponsorJeil Pharmaceutical Co., Ltd.Ran2022 to 2024Enrolled245ConditionsType 2 Diabetes MellitusArmsJT-003, JT-003 Placebo
5 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

13 authors.

Jun Hwa HongDivision of Endocrinology, Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, Korea.
Kyung Ah HanDivision of Endocrinology and Metabolism, Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.
You-Cheol HwangDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.
Eun-Gyoung HongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.
Hae Jin KimDepartment of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
Chang Beom LeeDivision of Endocrinology and Metabolism, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
Ho Chan ChoDepartment of Clinical Endocrinology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Korea.
Jong Chul WonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.
Hun-Sung KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Eui-Hyun KimDepartment of Internal Medicine, Daegu Fatima Hospital, Daegu, Korea.
Gwanpyo KohDepartment of Internal Medicine, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, Korea.
Kwang Hyun AhnProduct Development Division, Jeil Pharmaceutical Co. Ltd., Seoul, Korea.
Kyong Soo ParkDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.

Funding

Jeil Pharmaceutical Co. Ltd.
8 · The paper itself

Abstract

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

backgruoundThis study investigated the efficacy and safety of pioglitazone 30 mg/day add-on to inadequately controlled type 2 diabetes mellitus (T2DM) patients with treatment of dapagliflozin and metformin.

methodsIn this multicenter (34 sites), double-blind, randomized, phase 3 study, patients with T2DM with an inadequately controlled glycosylated hemoglobin (HbA1c) over 7.0% to treatment with dapagliflozin (10 mg/day) and metformin (≥1,000 mg/day) were randomized to receive additional pioglitazone 30 mg/day (n=124) or placebo (n=122) for 24 weeks. The primary outcome was the mean change of HbA1c from baseline to 24 weeks treatment. The efficacy and safety were evaluated with open label extension period, switching placebo to pioglitazone 30 mg/day at 48 weeks (ClinicalTrials.gov identifier: NCT05296044).

resultsThe HbA1c after 24 weeks treatment reduced from 7.8%±0.8% to 7.0%±0.6% (P<0.0001). The proportions of patients who achieved HbA1c less than 7.0% at 24 weeks were significantly higher in pioglitazone add-on group (51.61% in pioglitazone vs. 22.95% in placebo, P<0.0001), or less than 6.5% at 24 weeks (21.77% in pioglitazone vs. 2.46% in placebo, P<0.0001). Body weight gain was 2.0 kg at 24 weeks with pioglitazone 30 mg/day and -0.6 kg at 24 weeks with placebo.

conclusionAddition of pioglitazone 30 mg/day to T2DM patients who did not reach the target HbA1c (≤7%) with treatment of dapagliflozin 10 mg/day and metformin over 1,000 mg/day showed effective glucose lowering efficacy without significant hypoglycemia and good tolerability with low prevalence of edema in spite of modest weight gain.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesHypoglycemic AgentsMetforminPioglitazoneAdultAgedBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansMaleMiddle AgedBenzhydryl CompoundsBlood GlucosedapagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminPioglitazoneDiabetes mellitus, type 2Sodium-glucose transporter 2 inhibitorsThiazolidinediones

Identifiers

PMID41151541
PMCPMC12996957

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.