Trial reportDiabetes, obesity & metabolism2025

Efficacy and safety of lobeglitazone added to metformin and sitagliptin combination therapy in patients with type 2 diabetes: A 52-week, multicentre, randomized, placebo-controlled, phase III clinical trial.

Eun-Gyoung Hong, Kyung-Wan Min, SungWan Chun, Choon Hee Chung, Seungjoon Oh, Chang Beom Lee, Dong-Jun Kim, Hye Soon Kim, Ji Oh Mok, Tae Seo Sohn and 9 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
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. Cited by 4 papers.

1number the graph read from it
1cell of the map it votes in
4citing 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 →
-1.030 · no effect
HbA1clobeglitazone (0.5 mg/day) vs placebofavours the treatment · t2dfeeds one cell of the map
Δ -1.03<0.0001
RESULTS: At week 24, lobeglitazone treatment demonstrated a significantly greater reduction in HbA1c compared with placebo (-1.00% ± 0.09% vs. 0.02% ± 0.09%), with a between-group difference in the adjusted mean change [-1.03%; 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: 8 favour the treatment, 4 find no difference, 4 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 · 2025
Δ -1.03
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. 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

19 authors.

Eun-Gyoung HongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, South Korea.ORCID 0000-0003-3390-5706
Kyung-Wan MinDivision of Endocrinology and Metabolism, Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, South Korea.
SungWan ChunSoonchunhyang University Cheonan Hospital, Cheonan, South Korea.ORCID 0000-0001-7630-5204
Choon Hee ChungDepartment of Internal Medicine and Research Institute of Metabolism and Inflammation, Yonsei University Wonju College of Medicine, Wonju, South Korea.ORCID 0000-0003-1144-7206
Seungjoon OhKyung Hee University Hospital, Seoul, South Korea.ORCID 0000-0002-5047-6037
Chang Beom LeeDivision of Endocrinology and Metabolism, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri City, South Korea.ORCID 0000-0003-4891-834X
Dong-Jun KimDepartment of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Busan, South Korea.
Hye Soon KimKeimyung University School of Medicine, Daegu, South Korea.ORCID 0000-0001-6298-3506
Ji Oh MokDivision of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, South Korea.ORCID 0000-0003-4882-1206
Tae Seo SohnDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.ORCID 0000-0002-5135-3290
Jeong Hyun ParkDepartment of Internal Medicine, Busan Paik Hospital, College of Medicine, Inje University, Busan, South Korea.ORCID 0000-0002-0045-4438
Sung Hee ChoiSeoul National University College of Medicine, Seoul National University Bundang Hospital, Seoul, South Korea.ORCID 0000-0003-0740-8116
Sungrae KimBucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, South Korea.ORCID 0000-0001-6417-8412
Sang Soo KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University Hospital and Pusan National University School of Medicine, Busan, South Korea.ORCID 0000-0002-9687-8357
Kyu Yeon HurDivision of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.ORCID 0000-0002-3065-7252
Chong Hwa KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Sejong General Hospital, Bucheon, South Korea.ORCID 0000-0002-4563-7772
Young Min ChoDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.ORCID 0000-0002-2331-6126
Byung-Joon KimDepartment of Endocrinology & Metabolism, Gachon University Gil Medical Center, Incheon, South Korea.
Kun-Ho YoonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.ORCID 0000-0002-9109-2208

Funding

Chong Kun Dang Pharmaceutical Company, Seoul, Korea
8 · The paper itself

Abstract

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

aimsTo evaluate the efficacy and safety of adding lobeglitazone to a triple therapy regimen in Korean patients with type 2 diabetes whose blood glucose levels were inadequately controlled despite dual therapy with metformin and sitagliptin. MATERIALS AND

methodsThis randomised, double-blind, placebo-controlled, phase 3 study involved 231 Korean patients with type 2 diabetes whose HbA1c levels ranged from 7.0% to 10.0% despite treatment with metformin (≥1000 mg/day) and sitagliptin (100 mg/day). Participants received lobeglitazone (0.5 mg/day) or placebo for 24 weeks, followed by a 28-week open-label phase in which all patients received lobeglitazone. The primary endpoint was the change in glycated haemoglobin (HbA1c) at 24 weeks; secondary endpoints included changes in fasting plasma glucose (FPG), homeostatic model assessment for insulin resistance (HOMA-IR), HOMA for β-cell function (HOMA-β), quantitative insulin-sensitivity check index (QUICKI) and lipid profile. Safety assessments were also conducted.

resultsAt week 24, lobeglitazone treatment demonstrated a significantly greater reduction in HbA1c compared with placebo (-1.00% ± 0.09% vs. 0.02% ± 0.09%), with a between-group difference in the adjusted mean change [-1.03%; p < 0.0001]. Additionally, lobeglitazone significantly reduced FPG compared with placebo at week 24 and improved HOMA-IR, HOMA-β and QUICKI. Lipid parameters were also improved by lobeglitazone administration. Adverse events were similar in both treatment arms.

conclusionsThe addition of lobeglitazone in patients with type 2 diabetes inadequately controlled with metformin and sitagliptin is a beneficial therapeutic option, not only providing effective glycaemic control but also improving insulin function such as sensitivity and enhancing certain lipid parameters.

Indexed as

AdamantaneDiabetes Mellitus, Type 2Hypoglycemic AgentsMetforminSitagliptin PhosphateThiazolidinedionesAdultAgedBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansInsulin ResistanceMaleAdamantaneBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentslobeglitazoneMetforminPyrimidinesSitagliptin PhosphateThiazolidinedionesantidiabetic drugbeta cell functionclinical trialinsulin resistancethiazolidinedionestype 2 diabetes

Identifiers

PMID40726438
PMCPMC12409244

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Texttitle and abstract
LicenceCC BY-NC-ND
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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 OpenQuestion graph.