{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T01:21:17Z","timestamp":1777339277032,"version":"3.51.4"},"reference-count":19,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2014,7,17]],"date-time":"2014-07-17T00:00:00Z","timestamp":1405555200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabet. Med."],"published-print":{"date-parts":[[2014,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>Durability of good glycaemic control (HbA<jats:sub>1c<\/jats:sub>) is of importance as it can be the foundation for delaying diabetic complications. It has been hypothesized that early initiation of treatment with the combination of oral anti\u2010diabetes agents with complementary mechanisms of action can increase the durability of glycaemic control compared with metformin monotherapy followed by a stepwise addition of oral agents. Dipeptidyl peptidase\u20104 inhibitors are good candidates for early use as they are efficacious in combination with metformin, show weight neutrality and a low risk of hypoglycaemia. We aimed to test the hypothesis that early combined treatment of metformin and vildagliptin slows \u03b2\u2010cell deterioration as measured by HbA<jats:sub>1c<\/jats:sub>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Approximately 2000 people with Type\u00a02 diabetes mellitus who were drug\u2010naive or who were treated with metformin for less than 1\u00a0month, and who have HbA<jats:sub>1c<\/jats:sub> of 48\u201358\u00a0mmol\/mol (6.5\u20137.5%), will be randomized in a 1:1 ratio in <jats:styled-content style=\"fixed-case\">VERIFY<\/jats:styled-content>, a 5\u2010year multinational, double\u2010blind, parallel\u2010group study designed to compare early initiation of a vildagliptin\u2013metformin combination with standard\u2010of\u2010care initiation of metformin monotherapy, followed by the stepwise addition of vildagliptin when glycaemia deteriorates. Further deterioration will be treated with insulin. The primary analysis for treatment failure will be from a Cox proportional hazard regression model and the durability of glycaemic control will be evaluated by assessing treatment failure rate and the rate of loss in glycaemic control over time as co\u2010primary endpoints.<\/jats:p><\/jats:sec><jats:sec><jats:title>Summary<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">VERIFY<\/jats:styled-content> is the first study to investigate the long\u2010term clinical benefits of early combination treatment vs. the standard\u2010of\u2010care metformin monotherapy with a second agent added by threshold criteria.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dme.12508","type":"journal-article","created":{"date-parts":[[2014,5,23]],"date-time":"2014-05-23T12:52:07Z","timestamp":1400849527000},"page":"1178-1184","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["Study to determine the durability of glycaemic control with early treatment with a vildagliptin\u2013metformin combination regimen vs. standard\u2010of\u2010care metformin monotherapy\u2014the <scp>VERIFY<\/scp> trial: a randomized double\u2010blind trial"],"prefix":"10.1111","volume":"31","author":[{"given":"S.","family":"Del Prato","sequence":"first","affiliation":[{"name":"Department of Endocrinology and Metabolism Section of Metabolic Diseases and Diabetes University of Pisa Pisa Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. E.","family":"Foley","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceutical Cooperation Clinical Research and Development East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W.","family":"Kothny","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceutical Cooperation Clinical Research and Development East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Kozlovski","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Stumvoll","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Leipzig Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P. M.","family":"Pald\u00e1nius","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D. R.","family":"Matthews","sequence":"additional","affiliation":[{"name":"Oxford Centre for Diabetes Endocrinology and Metabolism Oxford UK"},{"name":"National Institute for Health Research (NIHR) Oxford Biomedical Research Centre Oxford UK"},{"name":"Harris Manchester College Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,7,17]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2010.01233.x"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.beem.2009.03.003"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa066224"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/db10-1392"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2008.00875.x"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2007.00835.x"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00280883"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-5491.2002.00718.x"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780090710"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa066224"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-0413"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.2337\/db09-9028"},{"key":"e_1_2_10_14_1","volume-title":"Global Guideline for the Treatment of Type\u00a02 Diabetes","author":"IDF","year":"2012"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-012-2534-0"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2008.00994.x"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0028-1082334"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12093"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1307684"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2010.03210.x"}],"container-title":["Diabetic Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdme.12508","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dme.12508","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dme.12508","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dme.12508","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T15:39:02Z","timestamp":1696347542000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/dme.12508"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,7,17]]},"references-count":19,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2014,10]]}},"alternative-id":["10.1111\/dme.12508"],"URL":"https:\/\/doi.org\/10.1111\/dme.12508","archive":["Portico"],"relation":{},"ISSN":["0742-3071","1464-5491"],"issn-type":[{"value":"0742-3071","type":"print"},{"value":"1464-5491","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,7,17]]},"assertion":[{"value":"2013-11-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2014-05-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2014-07-17","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}