{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T16:58:01Z","timestamp":1786121881559,"version":"build-2736575974"},"reference-count":20,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T00:00:00Z","timestamp":1777766400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T00:00:00Z","timestamp":1777766400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2026,7]]},"abstract":"ABSTRACT<\/jats:title>\n \n Aims<\/jats:title>\n This study assessed the efficacy and safety of a triple fixed\u2010dose combination (FDC) of sitagliptin, metformin, and glimepiride versus co\u2010administered metformin and glimepiride in Indian patients with uncontrolled Type 2 diabetes (T2D).<\/jats:p>\n <\/jats:sec>\n \n Materials and Methods<\/jats:title>\n \n In this Phase 3, randomised, double\u2010blind, double\u2010dummy study, adult patients with T2D and glycated haemoglobin (HbA\n 1c<\/jats:sub>\n ) of 8%\u201311%, despite treatment with metformin and glimepiride, were randomised 1:1 to triple FDC of sitagliptin 50\u2009mg, metformin 1000\u2009mg and glimepiride 1\u2009mg (SITA\u2009+\u2009MET\u2009+\u2009GLIM group) or metformin 1000\u2009mg and glimepiride 2\u2009mg (Co\u2010administration group) for 16\u2009weeks. Patients assigned to the SITA\u2009+\u2009MET\u2009+\u2009GLIM group could continue treatment for a 12\u2010week open\u2010label period. The primary endpoint was the change in HbA\n 1c<\/jats:sub>\n from baseline to Week 16.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Overall, 190 patients were randomised to the SITA\u2009+\u2009MET\u2009+\u2009GLIM group and 202 to the Co\u2010administration group. The least squares mean (standard error) change from baseline in HbA\n 1c<\/jats:sub>\n at Week 16 was \u22121.79 (0.07%) in the SITA\u2009+\u2009MET\u2009+\u2009GLIM group and \u22121.27 (0.06%) in the co\u2010administration group (estimated treatment difference \u22120.51; 95% confidence interval [CI] \u22120.69 to \u22120.33;\n p<\/jats:italic>\n \u2009<\u20090.0001). The proportion of patients with HbA\n 1c<\/jats:sub>\n below 7% at Week 16 was 32.1% in the SITA\u2009+\u2009MET\u2009+\u2009GLIM group and 12.6% in the Co\u2010administration group (\n p<\/jats:italic>\n \u2009<\u20090.0001). Adverse events occurred in 25 patients (13.2%) in the SITA\u2009+\u2009MET\u2009+\u2009GLIM group and 30 patients (14.9%) in the Co\u2010administration group.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The triple FDC was superior to co\u2010administered metformin and high\u2010dose glimepiride for achieving glycaemic control and was well tolerated in Indian patients with T2D.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n Clinical Trials Registry\u2013India identifier: CTRI\/2021\/11\/038169 (registered on 22 November 2021); URL:\n https:\/\/www.ctri.nic.in\/Clinicaltrials\/pmaindet2.php?EncHid=NjI1Mjk=&Enc=&userName=<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.70778","type":"journal-article","created":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T00:11:01Z","timestamp":1777853461000},"page":"6207-6216","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Sitagliptin, Metformin and Glimepiride Fixed\u2010Dose Combination Compared to Co\u2010Administration of Metformin and High\u2010Dose Glimepiride in Indian Patients With Type 2 Diabetes: A Randomised, Double\u2010Blind, Double\u2010Dummy, Phase 3 Clinical Study"],"prefix":"10.1111","volume":"28","author":[{"given":"Rakesh","family":"Sahay","sequence":"first","affiliation":[{"name":"Department of Endocrinology Osmania General Hospital Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ambanna","family":"Gowda","sequence":"additional","affiliation":[{"name":"Citizen Hospital Bengaluru Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manish Kumar","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Medicine Maya Hospital and Maternity Centre Kanpur Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. Gopal","family":"Rao","sequence":"additional","affiliation":[{"name":"Department of Medicine Government Medical College and Government General Hospital Srikakulam Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramesh","family":"Duraisamy","sequence":"additional","affiliation":[{"name":"Department of Diabetology Kovai Diabetes Speciality Centre and Hospital Coimbatore Tamil Nadu India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dinesh","family":"Gangwani","sequence":"additional","affiliation":[{"name":"Department of Medicine Priyadarshani Nursing Home Virar Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jitendra","family":"Shukla","sequence":"additional","affiliation":[{"name":"Department of Medicine Moti Lal Nehru Medical College Prayagraj Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vikas","family":"Agarwal","sequence":"additional","affiliation":[{"name":"Department of Medicine Surya Super Speciality Hospital Varanasi Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandesh Sahebarao","family":"Patil","sequence":"additional","affiliation":[{"name":"Department of Medicine Shree Siddhivinayak Maternity and Nursing Home Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ambrish","family":"C.","sequence":"additional","affiliation":[{"name":"Department of Diabetology Medstar Speciality Hospital Bengaluru Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satish Babu","family":"K. N.","sequence":"additional","affiliation":[{"name":"Sparsh Super Speciality Hospital Bengaluru Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arvind","family":"Palawat","sequence":"additional","affiliation":[{"name":"Department of Medicine Sawai Man Singh Medical College and Attached Hospitals Jaipur Rajasthan India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandip Krishnrao","family":"Gofne","sequence":"additional","affiliation":[{"name":"Department of Medicine District Civil Hospital Aurangabad Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhay Kumar","family":"Sahoo","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Metabolism Institute of Medical Sciences and Sum Hospital Bhubaneswar Odisha India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pradeep Kumar","family":"Rai","sequence":"additional","affiliation":[{"name":"Department of Internal 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