Evidence map›Paper›PMID 40563136›Full record

Trial reportDiabetes, obesity & metabolism2025

Impact of baseline alanine aminotransferase levels on the efficacy of dapagliflozin and sitagliptin: Latent class analysis from the DIVERSITY-CVR study.

Kohei Mochizuki, Ayako Fuchigami, Takahisa Hirose, Hiroshi Uchino

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells 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.

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

1 citing paper in PubMed.

  1. Trial
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

4 authors.

Kohei MochizukiDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University Graduate School of Medicine, Tokyo, Japan.
Ayako FuchigamiDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University Graduate School of Medicine, Tokyo, Japan.ORCID 0009-0004-8461-2246
Takahisa HiroseDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0001-6293-5010
Hiroshi UchinoDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0001-9282-918X

Funding

Mitsubishi Tanabe Pharma CorporationNippon Boehringer Ingelheim Co., LtdSumitomo Pharma Co., Ltd
6 · The paper itself

Abstract

aimsDapagliflozin and sitagliptin exhibit variable efficacy in managing type 2 diabetes mellitus (T2DM), with outcomes influenced by factors like body mass index (BMI). However, biochemical determinants of treatment response remain poorly defined. This study aimed to determine whether baseline alanine aminotransferase (ALT) levels can independently predict differential responses to these drugs. MATERIALS AND

methodsThis post hoc analysis of the Dapagliflozin Versus Sitagliptin for Type 2 Diabetes-Cardiovascular Risk (DIVERSITY-CVR) study, a randomized, open-label trial in Japan, included 340 patients with T2DM on metformin monotherapy or no treatment. Analysis of variance and regression analyses were conducted, adjusting for allocation factors (glycated haemoglobin [HbA1c] ≥/< 8.5%, BMI ≥/< 27 kg/m

resultsBaseline ALT levels were significantly associated with changes in HbA1c and time in range at 24 weeks. Patients with lower ALT showed better response to sitagliptin, while those with higher ALT exhibited enhanced efficacy with dapagliflozin across all models (p < 0.05). Regression analysis revealed significant interactions between ALT, BMI and HbA1c (p = 0.02, 0.03). A significant correlation between baseline ALT and HbA1c change was observed in the total cohort (p = 0.03) and sitagliptin group (p < 0.01).

conclusionsBaseline ALT is a potential predictor of differential efficacy between dapagliflozin and sitagliptin in T2DM, independent of BMI. Lower ALT correlated with enhanced sitagliptin efficacy, whereas higher ALT favoured dapagliflozin for glycaemic control.

trial registrationThe DIVERSITY-CVR study was registered with the University Hospital Medical Information Network Clinical Trial Registry (UMIN000028014).

Indexed as

Alanine TransaminaseBenzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesHypoglycemic AgentsSitagliptin PhosphateAgedBody Mass IndexFemaleGlycated HemoglobinHumansJapanMaleMetforminMiddle AgedTreatment OutcomeAlanine TransaminaseBenzhydryl CompoundsdapagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminSitagliptin Phosphatealanine aminotransferasebiomarkerbody mass indexdapagliflozinsitagliptintype 2 diabetes mellitus

Identifiers

PMID40563136
PMCPMC12326936

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
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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 OpenQuestion graph.