Trial reportDiabetes, obesity & metabolism2026

Efficacy and safety of combining empagliflozin in people with type 2 diabetes mellitus uncontrolled with metformin and sitagliptin: A randomised, double-blind, multicentre, therapeutic confirmatory phase 3 clinical trial.

Seung-Hwan Lee, Kyung Ah Han, Eun-Gyoung Hong, Jun Goo Kang, Choon Hee Chung, Jong Chul Won, Eon Ju Jeon, Jung-Hwan Cho, Ho Chan Cho, Sin Gon Kim and 6 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2026. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. Cited by 1 paper.

1number the graph read from it
1cell of the map it votes in
1citing 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 →
-1.000 · no effect
Glycemic controlfavours the treatment · against placebo · t2dfeeds one cell of the map
Δ -0.70-1.00 to -0.40p <.0001
RESULTS: After 24 weeks of treatment, HbA1c levels were significantly decreased in the empagliflozin 10 and 25 mg group versus the placebo group; the adjusted mean differences with empagliflozin 10 and 25 mg versus placebo were -0.7% (95% CI -1.0, -0.4; p <.0001) and -0.8% (95% CI -1.1, -0.5; p <.0001), respectively.

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.

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.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2026
Δ -0.70-1.00 to -0.40
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
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

1 citing paper in PubMed.

  1. Trial
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

16 authors.

Seung-Hwan LeeDivision of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0002-3964-3877
Kyung Ah HanDivision of Endocrinology and Metabolism, Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.ORCID 0000-0001-6436-1938
Eun-Gyoung HongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.ORCID 0000-0003-3390-5706
Jun Goo KangDepartment of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.ORCID 0000-0001-9523-7251
Choon Hee ChungDepartment of Internal Medicine and Research Institute of Metabolism and Inflammation, Yonsei University Wonju College of Medicine, Wonju, Korea.ORCID 0000-0003-1144-7206
Jong Chul WonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.ORCID 0000-0002-2219-4083
Eon Ju JeonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.ORCID 0000-0002-8858-5343
Jung-Hwan ChoDivision of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Changwon Hospital Sungkyunkwan University School of Medicine, Changwon, Korea.ORCID 0000-0001-8578-2117
Ho Chan ChoDepartment of Endocrinology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Korea.ORCID 0000-0003-0712-7728
Sin Gon KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.ORCID 0000-0002-7430-3675
Eun Seok KangDivision of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University, College of Medicine, Seoul, Korea.ORCID 0000-0002-0364-4675
So Hun KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Inha University of College of Medicine, Incheon, Korea.ORCID 0000-0002-2554-3664
Hae Jin KimDepartment of Endocrinology and Metabolism, Ajou University Hospital, Ajou University, School of Medicine, Suwon, Korea.ORCID 0000-0002-8958-7164
In-Kyung JeongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, Korea.ORCID 0000-0001-7857-546X
Sung Wan ChunDivision of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University, College of Medicine, Cheonan, Korea.ORCID 0000-0001-7630-5204
Young Min ChoDivision of Endocrinology and Metabolism, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0002-2331-6126

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.

aimThis study evaluated the efficacy and safety of empagliflozin 10 and 25 mg compared to placebo as add-on treatment for people with type 2 diabetes mellitus (T2DM) uncontrolled after ≥8 weeks of treatment with metformin and sitagliptin. MATERIALS AND

methodsA randomised, double-blind, multicentre, therapeutic confirmatory, phase 3 clinical trial was conducted in 172 patients with T2DM. Participants with glycosylated haemoglobin (HbA1c) levels 7%-10% receiving sitagliptin and metformin were randomised 1:1:1 to empagliflozin 10 mg, empagliflozin 25 mg, or placebo. The primary endpoint was the change in HbA1c from baseline to week 24.

resultsAfter 24 weeks of treatment, HbA1c levels were significantly decreased in the empagliflozin 10 and 25 mg group versus the placebo group; the adjusted mean differences with empagliflozin 10 and 25 mg versus placebo were -0.7% (95% CI -1.0, -0.4; p <.0001) and -0.8% (95% CI -1.1, -0.5; p <.0001), respectively. Fasting plasma glucose levels were also significantly decreased in both empagliflozin groups compared to the placebo group (both p <.0001). More patients reached HbA1c <7% or <6.5% after 24 weeks in the empagliflozin 10 and 25 mg groups versus the placebo group (both p <.05). Efficacy was maintained in the empagliflozin groups during a 28-week extension period. Empagliflozin add-on was associated with improvements in albuminuria and body weight. The incidence of adverse events was similar across groups; add-on empagliflozin was well tolerated.

conclusionsThese results suggest that coadministration of empagliflozin safely improves glycemic control in Korean patients with T2DM uncontrolled by sitagliptin and metformin.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesHypoglycemic AgentsMetforminSitagliptin PhosphateAdultAgedBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansMaleMiddle AgedBenzhydryl CompoundsBlood GlucoseempagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminSitagliptin PhosphateSodium-Glucose Transporter 2 Inhibitorsclinical trialempagliflozinmetforminsitagliptintype 2 diabetes mellitus

Identifiers

PMID41417560
PMCPMC12890737

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.