{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T18:36:12Z","timestamp":1793126172178,"version":"4.5.0"},"reference-count":37,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,5,31]],"date-time":"2026-05-31T00:00:00Z","timestamp":1780185600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,5,31]],"date-time":"2026-05-31T00:00:00Z","timestamp":1780185600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100013671","name":"Sun Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013671","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the efficacy, safety and immunogenicity of semaglutide injection (synthetic) (Test group) compared with the Reference semaglutide injection [Ozempic, (Reference group)] in Indian patients with Type 2 diabetes mellitus (T2DM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>This Phase III, randomised, open\u2010label, multi\u2010centre, parallel\u2010group, active\u2010controlled non\u2010inferiority study was conducted across 35 centres in India. Adults aged 18\u201365\u2009years with T2DM and baseline glycated haemoglobin (HbA1c) \u2265\u20097.0% to \u2264\u200910.5% despite stable metformin therapy and diet &amp; exercise control were randomised (1:1) to receive subcutaneous injections of Test semaglutide or Reference semaglutide once weekly for 24\u2009weeks, using an identical dose\u2010escalation regimen (from 0.25 to 2.0\u2009mg per week). The primary endpoint was change in HbA1c from baseline to Week 24. Secondary endpoints included changes in fasting and post\u2010prandial blood glucose, bodyweight and HbA1c &lt;\u20097.0% achievers, safety and immunogenicity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 314 patients were randomised, and 290 patients completed the study. At Week 24, both treatments produced significant and comparable reductions in HbA1c (Test: \u22122.04%, Reference: \u22121.95%;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001 within groups). The least\u2010squares mean difference (Test\u2010Reference) was \u22120.09% (95% CI: \u22120.26 to 0.09), meeting the pre\u2010specified non\u2010inferiority criterion. Improvements in fasting and post\u2010prandial blood glucose, patients achieving HbA1c &lt;\u20097.0% and bodyweight were similar between the two groups. The most common treatment\u2010emergent adverse events were predominantly mild\u2010to\u2010moderate gastrointestinal events (Test vs. Reference: 43.3% vs. 46.5%). No anti\u2010drug or neutralising antibodies were detected.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      The Test synthetic semaglutide injection demonstrated non\u2010inferior glycaemic efficacy, comparable safety in comparison to Reference semaglutide, supporting its use as an effective therapeutic option for patients with T2DM. Prospectively registered on the Clinical Trials Registry\u2014India, CTRI\/2025\/02\/080592 [Registered on: 14\/02\/2025], URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/ctri.nic.in\/Clinicaltrials\/pmaindet2.php?EncHid=MTIwODUw&amp;Enc=&amp;userName=\">https:\/\/ctri.nic.in\/Clinicaltrials\/pmaindet2.php?EncHid=MTIwODUw&amp;Enc=&amp;userName=<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.70891","type":"journal-article","created":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:09:31Z","timestamp":1780272571000},"page":"7094-7103","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase\n                    <scp>III<\/scp>\n                    , Active\u2010Controlled Study"],"prefix":"10.1111","volume":"28","author":[{"given":"Unnikrishnan","family":"Ambika Gopalakrishnan","sequence":"first","affiliation":[{"name":"Chellaram Diabetes Institute  Pune Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ameya Sudhakar","family":"Joshi","sequence":"additional","affiliation":[{"name":"Bhaktivedanta Hospital and Research Institute  Thane Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richa","family":"Giri","sequence":"additional","affiliation":[{"name":"GSVM Medical College  Kanpur Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shalin Jagdeep","family":"Shah","sequence":"additional","affiliation":[{"name":"Ratan Multi\u2010Speciality Hospital  Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jitendra","family":"Shukla","sequence":"additional","affiliation":[{"name":"Motilal Nehru Medical College  Prayagraj Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjiv","family":"Maheshwari","sequence":"additional","affiliation":[{"name":"Jawahar Lal Nehru Medical College  Ajmer Rajasthan India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rekha","family":"M. 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