{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T20:10:13Z","timestamp":1760818213936,"version":"build-2065373602"},"reference-count":19,"publisher":"BMJ","issue":"9","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2014,5,22]]},"published-print":{"date-parts":[[2014,9]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Dipeptidyl peptidase-4 (DPP-4) inhibitors including alogliptin are categorised as a newer class of oral hypoglycaemic, antidiabetic drugs to suppress the degradation of incretin hormones ((glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) by DPP-4. We have scheduled a large-scale, multicentre, prospective, observational study (Japan-Based clinical ReseArch Network for Diabetes Registry: J-BRAND Registry) to construct an extensive database over a long-term clinical course in patients with type 2 diabetes receiving oral hypoglycaemic agents (OHAs) and to evaluate the safety and efficacy of alogliptin in Japanese population.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>20\u2005000 patients with type 2 diabetes will be registered into two groups of 10\u2005000 each: group A patients will be treated with alogliptin, while group B patients will be treated with non-DPP-4 inhibitor OHA(s). Approximately 300 institutions nationwide will enrol and assign eligible patients equally to either group. Each patient's data will be collected every 6\u2005months for a 3-year period, during which time treatment with OHA(s) may be changed or discontinued, as per package insert for each OHA. Primary end points are safety variables to be compared between the two groups and their subgroups, with respect to hypoglycaemia, pancreatitis, skin disorders, infections and cancer. Secondary end points are efficacy variables including from-baseline changes of A1c, fasting glucose, fasting insulin and urinary albumin, which will be compared between groups\/subgroups. New onset and progression of microangiopathy will also be evaluated against OHA(s). Overall, the J-BRAND Registry will evaluate the safety and efficacy of antidiabetic OHA(s) including alogliptin, based on a large-scale database.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>This study will be conducted with the highest respect for individual participants according to this protocol, the Declaration of Helsinki, the Ethical Guidelines for Clinical Research (Japan Ministry of Health, Labour and Welfare, 2008) and relevant laws\/regulations. The present study will construct a valuable database of patients with type 2 diabetes treated with OHA(s) including alogliptin.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>UMIN000007976.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2013-004760","type":"journal-article","created":{"date-parts":[[2014,9,16]],"date-time":"2014-09-16T23:59:43Z","timestamp":1410911983000},"page":"e004760","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Protocol for a large-scale prospective observational study with alogliptin in patients with type 2 diabetes: J-BRAND Registry"],"prefix":"10.1136","volume":"4","author":[{"given":"Nobuya","family":"Inagaki","sequence":"first","affiliation":[{"name":"Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kohjiro","family":"Ueki","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yukio","family":"Tanizawa","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Metabolism, Hematological Sciences and Therapeutics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirotaka","family":"Watada","sequence":"additional","affiliation":[{"name":"Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiro","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuichiro","family":"Yamada","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Akita, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iichiro","family":"Shimomura","sequence":"additional","affiliation":[{"name":"Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rimei","family":"Nishimura","sequence":"additional","affiliation":[{"name":"Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan"},{"name":"Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tsutomu","family":"Yamazaki","sequence":"additional","affiliation":[{"name":"Clinical Research Support Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Kadowaki","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2014,9,16]]},"reference":[{"key":"2025101812361995000_4.9.e004760.1","unstructured":"Melmed S Polonsky KS Larsen PR . Williams textbook of endocrinology. 12th edn. Philadelphia: Elsevier\/Saunders, 2012."},{"key":"2025101812361995000_4.9.e004760.2","unstructured":"International Diabetes Federation. IDF diabetes atlas. 5th edn. Brussels, Belgium: International Diabetes Federation, 2011."},{"key":"2025101812361995000_4.9.e004760.3","unstructured":"Kahn CR Weir G King G . eds. Joslin's diabetes mellitus. 14th edn. 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