{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T14:19:51Z","timestamp":1787840391950,"version":"build-2784847793"},"reference-count":28,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,9]]},"abstract":"Abstract<\/jats:title>\n \n Introduction:<\/jats:title>\n The PIONEER REAL India study assessed the effectiveness of oral semaglutide in adults with type 2 diabetes (T2D).<\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n \n This was a 34\u201344-week, multicenter, non-interventional study in participants who had not previously received injectable glucose-lowering medications and had initiated treatment with oral semaglutide. Change in HbA\n 1c<\/jats:sub>\n from baseline to end-of-study (EoS) was the primary endpoint. Change in body weight, proportion of participants achieving HbA\n 1c<\/jats:sub>\n <7% and HbA\n 1c<\/jats:sub>\n reduction \u22651%-points plus body weight reduction \u22653% or \u22655%, also changes in HbA\n 1c<\/jats:sub>\n by baseline HbA\n 1c<\/jats:sub>\n (\u22649% and >9%) from baseline to EoS were assessed. Here, we present the results from on-treatment analyses.\n <\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n \n Of 388 enrolled, 70.1% of participants completed the study. At baseline, the mean age and T2D duration of the study population were 50.1 and 6.3 years; mean HbA\n 1c<\/jats:sub>\n and body weight were 9.0% and 89.0 kg, respectively. Estimated mean changes (95% confidence interval, CI) in HbA\n 1c<\/jats:sub>\n and body weight were \u2212 1.78%-points (\u22121.88, \u22121.68;\n P<\/jats:italic>\n < 0.0001) and \u2212 7.23 kg (\u22127.84, \u22126.63;\n P<\/jats:italic>\n < 0.0001), respectively. At EoS, 34.2% achieved HbA\n 1c<\/jats:sub>\n <7%. Estimated mean HbA\n 1c<\/jats:sub>\n changes (95% CI) for participants with baseline HbA\n 1c<\/jats:sub>\n \u22649% and >9% were \u2212 0.93%-points (\u22121.07, \u22120.79;\n P<\/jats:italic>\n < 0.0001) and \u2212 2.48%-points (\u22122.60, \u22122.35;\n P<\/jats:italic>\n < 0.0001), respectively. No new safety signals were observed.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions:<\/jats:title>\n \n Individuals with T2D treated with once-daily oral semaglutide experienced significant reductions in HbA\n 1c<\/jats:sub>\n and body weight, without any new safety events. These findings will add to the decision-making for initiating oral semaglutide in individuals with T2D in India.\n <\/jats:p>\n \n Trial registration:<\/jats:bold>\n NCT05502562.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.4103\/ijem.ijem_179_25","type":"journal-article","created":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T08:00:24Z","timestamp":1761552024000},"page":"523-530","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":2,"title":["Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes: Findings from PIONEER REAL India"],"prefix":"10.4103","volume":"29","author":[{"given":"Debmalya","family":"Sanyal","sequence":"first","affiliation":[{"name":"Department of Endocrinology, Ananda Clinic, Kolkata, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Banshi","family":"Saboo","sequence":"additional","affiliation":[{"name":"Department of Diabetology, Diabetes Care and Hormone Clinic, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjeev R.","family":"Phatak","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Metabolic Diseases, Vijayratna Diabetes Diagnostic and Treatment Centre, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prasanna K. M.","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Diabetes, Center for Diabetes and Endocrine Care, Bengaluru, Karnataka, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debasis","family":"Basu","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Diabetology, Metta Clinic, Kolkata, West Bengal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikhil","family":"Verma","sequence":"additional","affiliation":[{"name":"Department of Medicine, ESIC Medical College and Hospital, Faridabad, Haryana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arjun","family":"Nair","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs and Medical Education, Novo Nordisk India Private Ltd., Bengaluru, Karnataka, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kingshuk","family":"Bhattacharjee","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs and Medical Education, Novo Nordisk India Private Ltd., Bengaluru, Karnataka, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pankaj","family":"Aneja","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Metabolic Disorders, Naveda Healthcare Centre, Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brij M. M.","family":"Makkar","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Obesity, Dr Makkar\u2019s Diabetes and Obesity Centre, Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vijay","family":"Negalur","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Thyroid Specialities, Synergy Healthcare, Mumbai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ambrish","family":"Mithal","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Diabetes, Max Super Speciality Hospital, Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ambika G.","family":"Unnikrishnan","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Chellaram Diabetes Institute, Pune, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2025,10,25]]},"reference":[{"key":"R1-20251029","doi-asserted-by":"crossref","first-page":"951","DOI":"10.1016\/S2213-8587(17)30327-3","article-title":"Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): An open-label, randomised controlled trial","volume":"5","author":"Ueki","year":"2017","journal-title":"Lancet Diabetes Endocrinol"},{"key":"R2-20251029","doi-asserted-by":"crossref","first-page":"2753","DOI":"10.2337\/dci22-0034","article-title":"Management of hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)","volume":"45","author":"Davies","year":"2022","journal-title":"Diabetes Care"},{"key":"R3-20251029","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s13340-022-00605-x","article-title":"A consensus statement from the Japan Diabetes Society (JDS): A proposed algorithm for pharmacotherapy in people with type 2 diabetes","volume":"14","author":"Bouchi","year":"2022","journal-title":"Diabetol Int"},{"issue":"(Suppl 1)","key":"R4-20251029","first-page":"S125","article-title":"American Diabetes Association Professional Practice Committee. 9. Pharmacologic approaches to glycemic treatment: Standards of medical care in diabetes-2022","volume":"45","year":"2022","journal-title":"Diabetes Care"},{"key":"R7-20251029","doi-asserted-by":"crossref","first-page":"1724","DOI":"10.2337\/dc19-0749","article-title":"PIONEER 1 Investigators. PIONEER 1: Randomized clinical trial of the efficacy and safety of oral semaglutide monotherapy in comparison with placebo in patients with type 2 diabetes","volume":"42","author":"Aroda","year":"2019","journal-title":"Diabetes Care"},{"key":"R8-20251029","doi-asserted-by":"crossref","first-page":"2272","DOI":"10.2337\/dc19-0883","article-title":"PIONEER 2 Investigators. Oral semaglutide versus empagliflozin in patients with type 2 diabetes uncontrolled on metformin: The PIONEER 2 trial","volume":"42","author":"Rodbard","year":"2019","journal-title":"Diabetes Care"},{"key":"R9-20251029","doi-asserted-by":"crossref","first-page":"1466","DOI":"10.1001\/jama.2019.2942","article-title":"PIONEER 3 Investigators. Effect of additional oral semaglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: The PIONEER 3 randomized clinical trial","volume":"321","author":"Rosenstock","year":"2019","journal-title":"JAMA"},{"key":"R10-20251029","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1016\/S0140-6736(19)31271-1","article-title":"PIONEER 4 investigators. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): A randomised, double-blind, phase 3a trial","volume":"394","author":"Pratley","year":"2019","journal-title":"Lancet"},{"key":"R11-20251029","doi-asserted-by":"crossref","first-page":"515","DOI":"10.1016\/S2213-8587(19)30192-5","article-title":"PIONEER 5 Investigators. Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): A placebo-controlled, randomised, phase 3a trial","volume":"7","author":"Mosenzon","year":"2019","journal-title":"Lancet Diabetes Endocrinol"},{"key":"R12-20251029","doi-asserted-by":"crossref","first-page":"841","DOI":"10.1056\/NEJMoa1901118","article-title":"PIONEER 6 Investigators. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes","volume":"381","author":"Husain","year":"2019","journal-title":"N Engl J Med"},{"key":"R13-20251029","doi-asserted-by":"crossref","first-page":"528","DOI":"10.1016\/S2213-8587(19)30194-9","article-title":"PIONEER 7 investigators. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): A multicentre, open-label, randomised, phase 3a trial","volume":"7","author":"Pieber","year":"2019","journal-title":"Lancet Diabetes Endocrinol"},{"key":"R14-20251029","doi-asserted-by":"crossref","first-page":"2262","DOI":"10.2337\/dc19-0898","article-title":"PIONEER 8 Investigators. Efficacy, safety, and tolerability of oral semaglutide versus placebo added to insulin with or without metformin in patients with type 2 diabetes: The PIONEER 8 trial","volume":"42","author":"Zinman","year":"2019","journal-title":"Diabetes Care"},{"key":"R15-20251029","doi-asserted-by":"crossref","first-page":"377","DOI":"10.1016\/S2213-8587(20)30075-9","article-title":"PIONEER 9 investigators. Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): A 52-week, phase 2\/3a, randomised, controlled trial","volume":"8","author":"Yamada","year":"2020","journal-title":"Lancet Diabetes Endocrinol"},{"key":"R16-20251029","doi-asserted-by":"crossref","first-page":"392","DOI":"10.1016\/S2213-8587(20)30074-7","article-title":"PIONEER 10 Investigators. Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): An open-label, randomised, active-controlled, phase 3a trial","volume":"8","author":"Yabe","year":"2020","journal-title":"Lancet Diabetes Endocrinol"},{"key":"R17-20251029","doi-asserted-by":"crossref","first-page":"1799","DOI":"10.1111\/dom.15493","article-title":"Use of once-daily oral semaglutide and associated clinical outcomes among adults with type 2 diabetes in routine clinical practice in Canada: A multicentre, prospective real-world study (PIONEER REAL Canada)","volume":"26","author":"Jain","year":"2024","journal-title":"Diabetes Obes Metab"},{"key":"R18-20251029","doi-asserted-by":"crossref","first-page":"623","DOI":"10.1007\/s13300-023-01525-y","article-title":"Real-World Use of oral semaglutide in adults with type 2 diabetes: The PIONEER REAL Switzerland Multicentre, Prospective, Observational Study","volume":"15","author":"Kick","year":"2024","journal-title":"Diabetes Ther"},{"key":"R19-20251029","doi-asserted-by":"crossref","first-page":"2079","DOI":"10.1007\/s13300-024-01614-6","article-title":"PIONEER REAL Sweden: A multicentre, prospective, real-world observational study of oral semaglutide use in adults with type 2 diabetes in Swedish clinical practice","volume":"15","author":"Catrina","year":"2024","journal-title":"Diabetes Ther"},{"key":"R20-20251029","doi-asserted-by":"crossref","first-page":"838","DOI":"10.1007\/s12325-015-0245-x","article-title":"Effectiveness and persistence with liraglutide among patients with type 2 diabetes in routine clinical practice--EVIDENCE: A prospective, 2-year follow-up, observational, post-marketing study","volume":"32","author":"Gautier","year":"2015","journal-title":"Adv Ther"},{"key":"R21-20251029","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1007\/s12325-015-0199-z","article-title":"Impact of medication adherence and persistence on clinical and economic outcomes in patients with type 2 diabetes treated with liraglutide: A retrospective cohort study","volume":"32","author":"Buysman","year":"2015","journal-title":"Adv Ther"},{"key":"R22-20251029","doi-asserted-by":"crossref","first-page":"819","DOI":"10.1111\/dom.12285","article-title":"Improved real-world glycaemic outcomes with liraglutide versus other incretin-based therapies in type 2 diabetes","volume":"16","author":"Lee","year":"2014","journal-title":"Diabetes Obes Metab"},{"key":"R23-20251029","doi-asserted-by":"crossref","first-page":"63","DOI":"10.17925\/EE.2022.18.1.63","article-title":"Indian phenotype characteristics among patients with type 2 diabetes mellitus: Insights from a non-interventional nationwide registry in India","volume":"18","author":"Kalra","year":"2022","journal-title":"touchREV Endocrinol"},{"key":"R24-20251029","doi-asserted-by":"crossref","first-page":"2177","DOI":"10.1111\/dom.14453","article-title":"Insights into the early use of oral semaglutide in routine clinical practice: The IGNITE study","volume":"23","author":"Aroda","year":"2021","journal-title":"Diabetes Obes Metab"},{"key":"R25-20251029","doi-asserted-by":"crossref","first-page":"102","DOI":"10.1016\/j.clinthera.2024.11.005","article-title":"Real-world evidence on oral semaglutide for the management of type 2 diabetes. A narrative review for clinical practice","volume":"47","author":"Marassi","year":"2025","journal-title":"Clin Ther"},{"key":"R26-20251029","doi-asserted-by":"crossref","first-page":"4266","DOI":"10.1007\/s12325-024-02973-z","article-title":"PIONEER REAL UK: A multi-centre, prospective, real-world study of once-daily oral semaglutide use in adults with type 2 diabetes","volume":"41","author":"Saravanan","year":"2024","journal-title":"Adv Ther"},{"key":"R27-20251029","doi-asserted-by":"crossref","first-page":"1047","DOI":"10.1111\/jdi.14219","article-title":"PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan","volume":"15","author":"Suzuki","year":"2024","journal-title":"J Diabetes Investig"},{"key":"R28-20251029","doi-asserted-by":"crossref","first-page":"976888","DOI":"10.3389\/fpubh.2022.976888","article-title":"Factors associated with treatment adherence to treatment among in patients with type 2 diabetes in Iran: A cross-sectional study","volume":"10","author":"Pourhabibi","year":"2022","journal-title":"Front Public Health"},{"key":"R29-20251029","doi-asserted-by":"crossref","first-page":"394","DOI":"10.1016\/S0140-6736(21)01919-X","article-title":"Obesity management as a primary treatment goal for type 2 diabetes: Time to reframe the conversation","volume":"399","author":"Lingvay","year":"2022","journal-title":"Lancet"},{"key":"R30-20251029","doi-asserted-by":"crossref","first-page":"4812","DOI":"10.1111\/dom.16523","article-title":"PIONEER REAL Spain: A multicentre, prospective, real-world study of oral semaglutide use in adults with type 2 diabetes","volume":"27","author":"Delgado \u00c1lvarez","year":"2025","journal-title":"Diabetes Obes Metab"}],"container-title":["Indian Journal of Endocrinology and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.4103\/ijem.ijem_179_25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T13:21:55Z","timestamp":1787836915000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.4103\/ijem.ijem_179_25"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9]]},"references-count":28,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025]]}},"URL":"https:\/\/doi.org\/10.4103\/ijem.ijem_179_25","relation":{},"ISSN":["2230-8210","2230-9500"],"issn-type":[{"value":"2230-8210","type":"print"},{"value":"2230-9500","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9]]},"assertion":[{"value":"2025-04-25","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-15","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}