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            "title": "A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study",
            "creators": [
                {
                    "creatorType": "author",
                    "firstName": "Mohamed",
                    "lastName": "Hassanein"
                },
                {
                    "creatorType": "author",
                    "firstName": "Khalifa",
                    "lastName": "Abdallah"
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                {
                    "creatorType": "author",
                    "firstName": "Anja",
                    "lastName": "Schweizer"
                }
            ],
            "abstractNote": "BACKGROUND: Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial.\nCLINICAL TRIALS IDENTIFIER: NCT01758380.\nMETHODS: This multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%), previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily) or gliclazide plus metformin. The study included four office visits (three pre-Ramadan) and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA(1c) and weight were analyzed before and after Ramadan.\nRESULTS: The proportion of patients reporting confirmed (<3.9 mmol/L and/or severe) hypoglycemic events during Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test), and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173). The adjusted mean change pre- to post-Ramadan in HbA(1c) was 0.05%±0.04% with vildagliptin and -0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165). In both groups, the adjusted mean decrease in weight was -1.1±0.2 kg (P=0.987). Overall safety was similar between the treatments.\nCONCLUSION: In line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting during Ramadan, with a consistently low incidence of hypoglycemia across studies, accompanied by good glycemic and weight control. In contrast, gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies. This is suggested to be linked to the specific circumstances of this study, including frequent patient-physician contacts, Ramadan-focused advice, a recent switch in treatment, and very well-controlled patients, which is different from what is often seen in real life.",
            "publicationTitle": "Vascular Health and Risk Management",
            "publisher": "",
            "place": "",
            "date": "2014",
            "volume": "10",
            "issue": "",
            "section": "",
            "partNumber": "",
            "partTitle": "",
            "pages": "319-326",
            "series": "",
            "seriesTitle": "",
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            "journalAbbreviation": "Vasc Health Risk Manag",
            "DOI": "10.2147/VHRM.S64038",
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            "accessDate": "",
            "PMID": "",
            "PMCID": "",
            "ISSN": "1178-2048",
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            "shortTitle": "A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan",
            "language": "eng",
            "libraryCatalog": "NCBI PubMed",
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            "extra": "PMID: 24920915 \nPMCID: PMC4045264",
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