{
    "abstract": "To report the results of a 104-week extension to a 52-week study in which dapagliflozin plus saxagliptin (DAPA+SAXA) improved glycaemic control, liver fat and metabolic variables compared with glimepiride (GLIM) in participants with type 2 diabetes (T2D) receiving background metformin.\nThis extension to a 52-week global, multicentre, parallel-group, active-controlled, double-blind study (NCT02419612) continued randomized participants (1:1) on DAPA+SAXA (10/5\u00a0mg) plus placebo, or GLIM (1-6\u00a0mg) plus placebo, once daily. Eligible participants were aged \u226518\u2009years, had T2D (glycated haemoglobin [HbA1c] 58.5-91.3\u2009mmol/mol [7.5%-10.5%]), and a body mass index of 20.0 to 45.0\u00a0kg/m\nOverall, 382 participants entered and 338 completed the 104-week extension period (MRI substudy, n\u00a0=\u00a082). The need for treatment intensification during the 156-week period was lower for DAPA+SAXA+MET (37.0%) than GLIM+MET (55.6%; hazard ratio 0.52, 95% confidence interval [CI] 0.39-0.68; P\u2009<\u20090.001). At week 156, 21.4% of DAPA+SAXA+MET versus 11.7% of GLIM+MET participants achieved therapeutic glycaemic response (HbA1c <53\u2009mmol/mol; odds ratio 2.1, 95% CI 1.23-3.42; P\u00a0=\u00a00.006). DAPA+SAXA+MET led to greater adjusted mean reductions from baseline in liver fat and visceral and subcutaneous adipose tissue volumes versus GLIM+MET at week 122 (least-squares mean difference from GLIM+MET -4.89%, -0.41\u2009L and -0.44\u2009L, respectively; nominal P values\u2009\u2264\u20090.008). Safety was consistent with that of the monocomponents.\nOverall, glycaemic control, metabolic benefits and efficacy were better maintained with DAPA+SAXA+MET than with GLIM+MET in T2D.",
    "authors": [
        {
            "affiliation": "National Research Institute, Los Angeles, California, USA.",
            "firstname": "Juan P",
            "initials": "JP",
            "lastname": "Fr\u00edas"
        },
        {
            "affiliation": "AstraZeneca, Gaithersburg, Maryland, USA.",
            "firstname": "Jill",
            "initials": "J",
            "lastname": "Maaske"
        },
        {
            "affiliation": "Kelly Services, Gaithersburg, Maryland, USA.",
            "firstname": "Lisa",
            "initials": "L",
            "lastname": "Suchower"
        },
        {
            "affiliation": "Antaros Medical AB, BioVenture Hub, M\u00f6lndal, Sweden.",
            "firstname": "Lars",
            "initials": "L",
            "lastname": "Johansson"
        },
        {
            "affiliation": "Antaros Medical AB, BioVenture Hub, M\u00f6lndal, Sweden.\nMedTech West, Chalmers University of Technology, Gothenburg, Sweden.",
            "firstname": "Paul D",
            "initials": "PD",
            "lastname": "Hockings"
        },
        {
            "affiliation": "AstraZeneca, Gaithersburg, Maryland, USA.",
            "firstname": "Nayyar",
            "initials": "N",
            "lastname": "Iqbal"
        },
        {
            "affiliation": "Obesity and Endocrinology Research Group, Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.",
            "firstname": "John P H",
            "initials": "JPH",
            "lastname": "Wilding"
        }
    ],
    "conclusions": null,
    "copyrights": "\u00a9 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.",
    "doi": "10.1111/dom.14548\n10.1016/j.cgh.2020.08.061",
    "journal": "Diabetes, obesity & metabolism",
    "keywords": [
        "DPP-4 inhibitor",
        "dapagliflozin",
        "liver",
        "phase III study",
        "sulphonylureas",
        "type 2 diabetes"
    ],
    "methods": null,
    "publication_date": "2021-09-14",
    "pubmed_id": "34514692\n23877982\n31862752\n28714183\n28769579\n27385192\n26246458\n27403645\n26324329\n25352655\n31542292\n24563333\n25735400\n32052516\n32072735\n15855602\n25873639\n32039382\n29971527\n29859912\n28345814\n30867626\n18384521\n30333032\n31965579\n32882428\n31862749\n14502098\n11558867\n29947099",
    "results": "Overall, 382 participants entered and 338 completed the 104-week extension period (MRI substudy, n\u00a0=\u00a082). The need for treatment intensification during the 156-week period was lower for DAPA+SAXA+MET (37.0%) than GLIM+MET (55.6%; hazard ratio 0.52, 95% confidence interval [CI] 0.39-0.68; P\u2009<\u20090.001). At week 156, 21.4% of DAPA+SAXA+MET versus 11.7% of GLIM+MET participants achieved therapeutic glycaemic response (HbA1c <53\u2009mmol/mol; odds ratio 2.1, 95% CI 1.23-3.42; P\u00a0=\u00a00.006). DAPA+SAXA+MET led to greater adjusted mean reductions from baseline in liver fat and visceral and subcutaneous adipose tissue volumes versus GLIM+MET at week 122 (least-squares mean difference from GLIM+MET -4.89%, -0.41\u2009L and -0.44\u2009L, respectively; nominal P values\u2009\u2264\u20090.008). Safety was consistent with that of the monocomponents.",
    "title": "Long-term effects of dapagliflozin plus saxagliptin versus glimepiride on a background of metformin in patients with type 2 diabetes: Results of a 104-week extension to a 52-week randomized, phase 3 study and liver fat MRI substudy.",
    "xml": "<Element 'PubmedArticle' at 0x788505dabab0>"
}