Evidence mapPaperPMID 41525167Full record

Trial reportDiabetes care2026

Empagliflozin in HNF1A-MODY (MODY3): A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial.

Henrik Maagensen, Stine O Høyerup, Johanne S Jensen, Anne C B Thuesen, Julie L Forman, Henrik H Thomsen, Henrik Vestergaard, Filip K Knop, Torben Hansen, Sofie Hædersdal and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · 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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Henrik MaagensenCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.ORCID 0000-0002-0399-9898
Stine O HøyerupCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
Johanne S JensenCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
Anne C B ThuesenNovo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Julie L FormanSection of Biostatistics, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Henrik H ThomsenMedical Diagnostic Center, University Clinic for Innovative Patient Pathways, Regional Hospital Central Jutland, Viborg, Denmark.
Henrik VestergaardCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
Filip K KnopCenter for Clinical Metabolic Research, Copenhagen University Hospital - Herlev and Gentofte, Hellerup, Denmark.
Torben HansenNovo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Sofie HædersdalCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
Julie StøyDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Tina VilsbøllCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.ORCID 0000-0002-0456-6787

Funding

DexcomNovo Nordisk Fonden
6 · The paper itself

Abstract

objectiveMaturity-onset diabetes of the young (MODY) caused by pathogenic variants in HNF1A is a common form of monogenic diabetes. Sulfonylurea drugs are considered first-line treatment of HNF1A-MODY (MODY3), but intensified treatment is often needed. HNF1A encodes a transcription factor involved in the regulation of the sodium-glucose cotransporter 2 (SGLT2). Accordingly, the glucose-lowering efficacy of SGLT2 inhibitors in HNF1A-MODY is questionable. Here, we assess the glucose-lowering effect of the SGLT2 inhibitor empagliflozin as an add-on for treatment of individuals with HNF1A-MODY. RESEARCH DESIGN AND

methodsMOD3ST-TRIAL was a randomized, double-blind, placebo-controlled crossover trial. Adults with HNF1A-MODY treated with at least one glucose-lowering drug were randomized to be treated with empagliflozin 25 mg for 4 weeks followed by a 2-week washout period and then received placebo for 4 weeks or the opposite sequence. The primary outcome was mean glucose concentration assessed by 10 days of continuous glucose monitoring (CGM).

resultsNineteen individuals were randomized and 18 participants (n = 10 women [56%]; median [Q1, Q3] HbA1c 7.5% [7.0, 8.4] or 58 [53, 68] mmol/mol, mean [SD] CGM glucose concentration 10.4 [2.5] mmol/L) completed the study. Compared with placebo, empagliflozin lowered the mean glucose level 2.3 mmol/L (95% CI 1.3 to 3.3; P = 0.0001). There were no significant differences in hypoglycemic outcomes. Adverse events were generally mild and transient, and no severe adverse events or study drug discontinuations were attributable to empagliflozin.

conclusionsEmpagliflozin used for 4 weeks in adjunction with other glucose-lowering treatments markedly improved glycemia compared with placebo in individuals with HNF1A-MODY without significantly increasing risk of hypoglycemia or unexpected adverse effects.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesHypoglycemic AgentsAdultBlood GlucoseCross-Over StudiesDouble-Blind MethodFemaleHepatocyte Nuclear Factor 1-alphaHumansMaleMiddle AgedSodium-Glucose Transporter 2 InhibitorsBenzhydryl CompoundsBlood GlucoseempagliflozinGlucosidesHepatocyte Nuclear Factor 1-alphaHNF1A protein, humanHypoglycemic AgentsSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID41525167
PMCPMC13294792

What Socratic holds

Textmetadata
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Registered trials

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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 Socratic graph.