Trial reportDiabetes, obesity & metabolism2026

Lobeglitazone improves glycaemic control as add-on therapy to empagliflozin plus metformin in patients with type 2 diabetes mellitus: A double-blind, randomised, placebo-controlled trial.

Da Hea Seo, Kyung Wan Min, Ho Sang Sohn, Sang Yong Kim, In-Kyung Jeong, Cheol-Young Park, Kun-Ho Yoon, So Hun Kim, Bong-Soo Cha

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2026. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it favours the comparator in 1. Cited by 2 papers.

2numbers 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 →
-0.880 · no effect
Change from baseline in glycated haemoglobin (HbA1c) at 24 weekslobeglitazone 0.5 mg/day vs placebo, in background empagliflozin dose (Study 2: ≥1000 mg/day metformin and empagliflozin 25 mg/day)favours the treatment · t2dfeeds one cell of the map
Δ -0.62-0.79 to -0.45<0.001
RESULTS: At 24 weeks, the mean change in HbA1c was significantly greater with lobeglitazone than with placebo, regardless of the background empagliflozin dose (-0.71%; 95% confidence interval, -0.88 to -0.55; p < 0.001 in Study 1 and -0.62%; -0.79 to -0.45; p < 0.001 in Study 2).
Change from baseline in glycated haemoglobin (HbA1c) at 24 weekslobeglitazone 0.5 mg/day vs placebo, in background empagliflozin dose (Study 1: ≥1000 mg/day metformin and empagliflozin 10 mg/day)favours the treatment · t2dfeeds one cell of the map
Δ -0.71-0.88 to -0.55<0.001
RESULTS: At 24 weeks, the mean change in HbA1c was significantly greater with lobeglitazone than with placebo, regardless of the background empagliflozin dose (-0.71%; 95% confidence interval, -0.88 to -0.55; p < 0.001 in Study 1 and -0.62%; -0.79 to -0.45; p < 0.001 in Study 2).

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×adverse events & safety

ContradictsOpen on the map →What to test next →

6 readable studies in this cell: 3 favour the treatment, 2 find no difference, 1 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 2 contradict · against placebo
Without it
0.00This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2026
Δ -0.62-0.79 to -0.45
NCT00839527685 enrolled · 2009
Δ 0.250.10 to 0.40
NCT00727857600 enrolled · 2007
Δ 0.840.50 to 1.18
NCT00770653305 enrolled · 2007
Δ 28.1-95.6 to 152
NCT0158944577 enrolled · 2008
Δ -0.64-4.40 to 2.40
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

2 citing papers in PubMed.

  1. Trial
  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

9 authors.

Da Hea SeoDivision of Endocrinology and Metabolism, Department of Internal Medicine, Inha University College of Medicine, Incheon, Republic of Korea.
Kyung Wan MinDivision of Endocrinology and Metabolism, Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Republic of Korea.
Ho Sang SohnDepartment of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Republic of Korea.
Sang Yong KimDepartment of Endocrinology and Metabolism, Chosun University Hospital, Chosun University School of Medicine, Gwangju, Republic of Korea.
In-Kyung JeongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.ORCID 0000-0001-7857-546X
Cheol-Young ParkDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-9415-9965
Kun-Ho YoonDivision of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.ORCID 0000-0002-9109-2208
So Hun KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Inha University College of Medicine, Incheon, Republic of Korea.ORCID 0000-0002-2554-3664
Bong-Soo ChaDivision of Endocrinology and Metabolism, Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0003-0542-2854

Funding

Chong Kun Dang Pharmaceutical Corp., Seoul, Republic of Korea
8 · The paper itself

Abstract

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

aimsThis study aimed to evaluate the efficacy and safety of triple therapy with lobeglitazone 0.5 mg as an add-on treatment compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and empagliflozin. MATERIALS AND

methodsIn this Phase 3, multicentre, double-blind, randomised trial, patients with T2DM who had an insufficient response to metformin (≥1000 mg/day) and empagliflozin 10 mg/day (Study 1) or 25 mg/day (Study 2) were randomised to receive either lobeglitazone 0.5 mg/day, or placebo once daily for 24 weeks. Participants then entered an open-label extension phase for an additional 28 weeks, bringing the total treatment duration to 52 weeks. The primary endpoint was the change from baseline in glycated haemoglobin (HbA1c) at 24 weeks.

resultsAt 24 weeks, the mean change in HbA1c was significantly greater with lobeglitazone than with placebo, regardless of the background empagliflozin dose (-0.71%; 95% confidence interval, -0.88 to -0.55; p < 0.001 in Study 1 and -0.62%; -0.79 to -0.45; p < 0.001 in Study 2). A higher proportion of patients achieved HbA1c levels <7% with lobeglitazone compared to placebo (48.7% vs. 13.4% in Study 1, and 44.4% vs. 13.0% in Study 2; p < 0.001). Although the incidence of adverse events was numerically different between groups, no statistically significant differences were observed, indicating a generally comparable profile for the triple combination therapy with metformin, empagliflozin, and lobeglitazone.

conclusionsLobeglitazone as an add-on to empagliflozin and metformin significantly improved glycaemic control in patients with T2DM inadequately controlled on metformin and empagliflozin dual therapy. The treatment was well tolerated, with a low incidence of adverse events.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesHypoglycemic AgentsMetforminPyrimidinesThiazolidinedionesAdultAgedBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinGlycemic ControlHumansBenzhydryl CompoundsBlood GlucoseempagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentslobeglitazoneMetforminPyrimidinesThiazolidinedionesclinical trialmetforminSGLT2 inhibitorthiazolidinedionestype 2 diabetes

Identifiers

PMID41236870
PMCPMC12673466

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.