{
  "abstract": "Aims: To evaluate the long‐term efficacy and safety of teneligliptin add‐on in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and empagliflozin.\n\nMaterials and Methods: In this randomised, double‐blind, phase 3 trial, 214 patients received teneligliptin 20 mg (n = 107) or placebo (n = 107) once daily for 24 weeks, in addition to metformin (≥ 1000 mg/day) and empagliflozin (25 mg/day). In a subsequent 28‐week open‐label extension, all patients received teneligliptin 20 mg/day. The primary endpoint was HbA1c change from baseline to week 24.\n\nResults: At week 24, the least squares mean (LSM) change in HbA1c from baseline was −0.70% ± 0.06% in the teneligliptin group and −0.03% ± 0.06% in the placebo group, with a placebo‐adjusted LSM change of −0.67% (95% CI, −0.84 to −0.49; p < 0.0001), demonstrating the superiority of teneligliptin. A significant between‐group difference was already evident at week 4 (placebo‐adjusted LSM change, −0.36%; p < 0.0001). Significant reductions in fasting plasma glucose and glycated albumin and improvement in pancreatic β‐cell function were observed at week 24. During the open‐label extension, glycaemic improvements were maintained through week 52, although no concurrent randomised control was available beyond week 24. Placebo‐group patients achieved a similar benefit after switching to teneligliptin. Safety outcomes did not differ between groups.\n\nConclusions: Adding teneligliptin to metformin and empagliflozin in patients with inadequately controlled T2DM significantly improved glycaemic control and β‐cell function over 24 weeks and was well tolerated through 52 weeks.\n\nTrail Registration: ClinicalTrials.gov Identifier: NCT05504226.",
  "abstract_shown": true,
  "affiliations": [
    "Division of Endocrinology and Metabolism, Department of Internal Medicine Yeungnam University College of Medicine Daegu Korea",
    "Division of Endocrinology and Metabolism, Department of Internal Medicine Nowon Eulji Medical Center, Eulji University School of Medicine Seoul Korea",
    "Division of Endocrinology and Metabolism, Department of Internal Medicine Konkuk University School of Medicine Seoul Korea",
    "Division of Endocrinology and Metabolism, Department of Internal Medicine Chosun University School of Medicine Gwangju Korea",
    "Department of Internal Medicine CHA Bundang Medical Center, CHA University School of Medicine Seongnam Korea",
    "Department of Internal Medicine Chungnam National University School of Medicine Daejeon Korea",
    "Department of Internal Medicine Asan Medical Center, University of Ulsan College of Medicine Seoul Korea",
    "Department of Internal Medicine Chungbuk National University Hospital Cheongju Korea",
    "Division of Endocrinology and Metabolism, Department of Internal Medicine Korea University Ansan Hospital, Korea University College of Medicine Ansan Korea",
    "Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine The Catholic University of Korea Seoul Korea",
    "Division of Endocrinology and Metabolism, Department of Internal Medicine Uijeongbu Eulji Medical Center, Eulji University Uijeongbu Korea",
    "Division of Endocrinology and Metabolism, Department of Internal Medicine Kyung Hee University Hospital at Gangdong, and Kyung Hee University School of Medicine Seoul Korea",
    "Division of Endocrinology, Department of Internal Medicine Yongin Severance Hospital, Yonsei University College of Medicine Yongin South Korea",
    "Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, College of Medicine Inje University Busan Korea",
    "Division of Endocrinology and Metabolism, Department of Internal Medicine Yonsei University College of Medicine, 50‐1 Yonsei‐Ro, Seodaemun‐Gu Seoul Korea"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 15,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Jun Sung Moon",
      "orcid": "0000-0003-1569-3068"
    },
    {
      "affs": [
        1
      ],
      "name": "Kyung Ah Han",
      "orcid": "0000-0001-6436-1938"
    },
    {
      "affs": [
        2
      ],
      "name": "Dong‐Lim Kim"
    },
    {
      "affs": [
        3
      ],
      "name": "Sang Yong Kim"
    },
    {
      "affs": [
        4
      ],
      "name": "Soo‐Kyung Kim"
    },
    {
      "affs": [
        5
      ],
      "name": "Bon Jeong Ku"
    },
    {
      "affs": [
        6
      ],
      "name": "Woo Je Lee"
    },
    {
      "affs": [
        7
      ],
      "name": "Tae Keun Oh",
      "orcid": "0000-0002-2998-9671"
    },
    {
      "affs": [
        8
      ],
      "name": "Ji A Seo"
    },
    {
      "affs": [
        9
      ],
      "name": "Sang‐Ah Chang"
    },
    {
      "affs": [
        10
      ],
      "name": "Moon‐Kyu Lee"
    },
    {
      "affs": [
        11
      ],
      "name": "Kyu Jeung Ahn"
    },
    {
      "affs": [
        12
      ],
      "name": "Chul Sik Kim",
      "orcid": "0000-0003-0855-6348"
    },
    {
      "affs": [
        13
      ],
      "name": "Tae Nyun Kim"
    },
    {
      "affs": [
        14
      ],
      "name": "Bong‐Soo Cha",
      "orcid": "0000-0003-0542-2854"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/cm8bhhryb8t3a.bib",
  "cited_by": 0,
  "doi": "10.1111/dom.71315",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13730988/",
  "id": "cm8bhhryb8t3a",
  "issns": [
    "1462-8902",
    "1463-1326"
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  "landing_url": "https://doi.org/10.1111/dom.71315",
  "language": "en",
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Article"
    ],
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      "openalex",
      "2712|Diabetes Treatment and Management"
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  "openalex": "W7220426114",
  "pdf_url": "https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/dom.71315",
  "pmcid": "PMC13730988",
  "pmid": "42832816",
  "published": "2026-10-05",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/cm8bhhryb8t3a.ris",
  "sources": [
    {
      "first_seen": "2026-11-08T12:21:16Z",
      "native_id": "PMC13730988",
      "source": "pmc",
      "url": "https://doi.org/10.1111/dom.71315"
    }
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2712|Diabetes Treatment and Management",
      "subfield": "endocrinology-metabolism"
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  ],
  "title": "A 52‐Week Efficacy and Safety Study of Teneligliptin, as an Add‐On to Empagliflozin and Metformin in Patients With Type 2 Diabetes Mellitus: A Randomised, Double‐Blind, Placebo‐Controlled Phase 3 Trial (TERA305 Study)",
  "title_text": "A 52‐Week Efficacy and Safety Study of Teneligliptin, as an Add‐On to Empagliflozin and Metformin in Patients With Type 2 Diabetes Mellitus: A Randomised, Double‐Blind, Placebo‐Controlled Phase 3 Trial (TERA305 Study)",
  "type": "peer-reviewed",
  "updated_at": "2026-11-08T12:21:16Z",
  "url": "https://research.draconitic.com/paper/cm8bhhryb8t3a",
  "venue": "Diabetes, Obesity & Metabolism",
  "versions": []
}