{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T23:42:16Z","timestamp":1771544536795,"version":"3.50.1"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2021,3,9]],"date-time":"2021-03-09T00:00:00Z","timestamp":1615248000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,3,9]],"date-time":"2021-03-09T00:00:00Z","timestamp":1615248000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"PegBio Co., Ltd"},{"name":"National Major Scientific and Technological \u201cSpecial Project for \u201cSignificant New Drugs Development\u201d during the thirteenth Five Year Plan Period","award":["2016ZX09101033"],"award-info":[{"award-number":["2016ZX09101033"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Diabetologia"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Aims\/hypothesis<\/jats:title>\n                <jats:p>Glucagon-like peptide 1 receptor agonists (GLP-1 RA) such as exenatide are used as monotherapy and add-on therapy for maintaining glycaemic control in patients with type 2 diabetes mellitus. The current study investigated the safety and efficacy of once-weekly PB-119, a PEGylated exenatide injection, in treatment-naive patients with type 2 diabetes.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this Phase II, randomised, placebo-controlled, double-blind study, we randomly assigned treatment-naive Chinese patients with type 2 diabetes in a 1:1:1:1 ratio to receive subcutaneous placebo or one of three subcutaneous doses of PB-119 (75, 150, and 200\u00a0\u03bcg) for 12\u00a0weeks. The primary endpoint was the change in HbA<jats:sub>1c<\/jats:sub> from baseline to week 12, and other endpoints were fasting plasma glucose, 2\u00a0h postprandial glucose (PPG), and proportion of patients with HbA<jats:sub>1c<\/jats:sub>\u2009&lt;\u200953\u00a0mmol\/mol (&lt;7.0%) and \u226448\u00a0mmol\/mol (\u22646.5%) at 2, 4, 8 and 12\u00a0weeks of treatment. Safety was assessed in all patients who received at least one dose of study drug.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>We randomly assigned 251 patients to one of the four treatment groups (<jats:italic>n<\/jats:italic>\u2009=\u200962 in placebo and 63 each in PB-119 75\u00a0\u03bcg, 150\u00a0\u03bcg and 200\u00a0\u03bcg groups). At the end of 12\u00a0weeks, mean differences in HbA<jats:sub>1c<\/jats:sub> in the treatment groups were \u22127.76\u00a0mmol\/mol (95% CI \u22129.23, \u22124.63, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) (\u22120.72%, 95% CI \u22121.01, \u22120.43), \u221212.89\u00a0mmol\/mol (95% CI \u221216.05, \u22129.72, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) (\u22121.18%, 95% CI \u22121.47, \u22120.89) and \u221211.14 mmol\/mol (95% CI \u221214.19, \u22127.97, <jats:italic>p<\/jats:italic>\u2009&lt;0\u2009.001) (\u22121.02%, 95% CI \u22121.30, \u22120.73) in the 75\u00a0\u03bcg, 150\u00a0\u03bcg and 200\u00a0\u03bcg\u00a0PB-119 groups, respectively, compared with that in the placebo group after adjusting for baseline HbA<jats:sub>1c<\/jats:sub>. Similar results were also observed for other efficacy endpoints across different time points. There was no incidence of treatment-emergent serious adverse event, severe hypoglycaemia or death.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions\/interpretation<\/jats:title>\n                <jats:p>All tested PB-119 doses had superior efficacy compared with placebo and were safe and well tolerated over 12\u00a0weeks in treatment-naive Chinese patients with type 2 diabetes.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> NCT03520972<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Funding<\/jats:title>\n                <jats:p>The study was funded by National Major Scientific and Technological Special Project for Significant New Drugs Development and PegBio.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Graphical abstract<\/jats:title>\n                \n              <\/jats:sec>","DOI":"10.1007\/s00125-021-05392-9","type":"journal-article","created":{"date-parts":[[2021,3,9]],"date-time":"2021-03-09T06:44:11Z","timestamp":1615272251000},"page":"1066-1078","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled 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