{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T12:56:42Z","timestamp":1777294602053,"version":"3.51.4"},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T00:00:00Z","timestamp":1776124800000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Diabetes"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>India ranks second in the global diabetes epidemic, with about 89\u2009million individuals living with Type 2 diabetes mellitus (T2DM). We compared the efficacy and safety of fixed\u2010dose combination (FDC) of glimepiride, voglibose, and extended\u2010release metformin (GLIME+VOGLI+MET\u2010ER) with voglibose and metformin (VOGLI+MET) and glimepiride and metformin (GLIME+MET).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A Phase IV, randomized, open\u2010label, active\u2010controlled study was performed in adult patients with T2DM poorly controlled with metformin. Patients received twice daily doses of GLIME+VOGLI+MET\u2010ER (1\u2009+\u20090.2\u2009+\u2009500\u2009mg: Trivolib 1, 2\u2009+\u20090.2\u2009+\u2009500\u2009mg: Trivolib 2); or VOGLI+MET (0.2\u2009+\u2009500\u2009mg, 0.3\u2009+\u2009500\u2009mg) or GLIME+MET (1\u2009+\u2009500\u2009mg, 2\u2009+\u2009500\u2009mg). The primary endpoint was the change in HbA1c from baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of the 458 patients screened, 399 were randomized (GLIME+VOGLI+MET\u2010ER [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009133], VOGLI+MET (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009135), and GLIME+MET [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009131]). The mean baseline HbA1c was ~8.35% (~67.77\u2009mmol\/mol). All the treatments showed a significant reduction in HbA1c at Weeks 12 and 24. Mean change in % (mmol\/mol) HbA1c was significantly more with GLIME+VOGLI+MET\u2010ER versus VOGLI+MET and GLIME+MET at Week 12 (\u22121.02\u2009\u00b1\u20090.60 [\u221211.2\u2009\u00b1\u20096.52] vs. \u22120.68\u2009\u00b1\u20090.64 [\u22127.49\u2009\u00b1\u20096.95],\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001 and \u22120.88\u2009\u00b1\u20090.49 [\u22129.65\u2009\u00b1\u20095.34],\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0154) and Week 24 (\u22121.57\u2009\u00b1\u20090.74 [\u221217.2\u2009\u00b1\u20098.14] vs. \u22121.11\u2009\u00b1\u20090.80 [\u221212.2\u2009\u00b1\u20098.79],\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001 and \u22121.28\u2009\u00b1\u20090.60 [\u221214.0\u2009\u00b1\u20096.56],\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0002). Overall, 49 adverse events (AEs) were reported in 32\/399 (8.0%) patients. One patient each in GLIME+VOGLI+MET\u2010ER and VOGLI+MET groups had level 1 hypoglycemia requiring no management. No severe or serious AEs were reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In adult patients with T2DM inadequately controlled on metformin monotherapy, GLIME+VOGLI+MET\u2010ER demonstrated superior HbA1c reduction compared with VOGLI+MET and GLIME+MET at Weeks 12 and 24. Study medications were safe and well\u2010tolerated.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      Clinical Trial Registry India\u2014CTRI\/2020\/11\/029080 [Registered on: 12\/11\/2020].\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/1753-0407.70217","type":"journal-article","created":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T12:20:36Z","timestamp":1776169236000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and Safety of Glimepiride, Voglibose, and Metformin\n                    <scp>ER<\/scp>\n                    in Type 2 Diabetes: A Randomized, Active\u2010Controlled Study"],"prefix":"10.1111","volume":"18","author":[{"given":"Brij","family":"Mohan","sequence":"first","affiliation":[{"name":"Brij Medical Centre Pvt Ltd  Kanpur India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. Vasanth","family":"Kumar","sequence":"additional","affiliation":[{"name":"Gandhi Hospital  Secunderabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prakash Harishchandra","family":"Kurmi","sequence":"additional","affiliation":[{"name":"Shivam Hospital  Ahmedabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandeep Kumar","family":"Gupta","sequence":"additional","affiliation":[{"name":"M.V. Hospital and Research Centre  Lucknow India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neelaveni","family":"Kudugunti","sequence":"additional","affiliation":[{"name":"Osmania General Hospital  Hyderabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bharat","family":"Das","sequence":"additional","affiliation":[{"name":"Sparsh Hospital &amp; Critical Care Private Limited  Bhubaneswar India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kartikeya","family":"Parmar","sequence":"additional","affiliation":[{"name":"B.J. Medical College &amp; Civil Hospital  Ahmedabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alok","family":"Kanungo","sequence":"additional","affiliation":[{"name":"Dr. Alok Kanungo's Diabetic Center  Bhubaneswar India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanjay","family":"Saran","sequence":"additional","affiliation":[{"name":"SMS Medical College &amp; Hospital  Jaipur India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Preetam Ahirrao","family":"Kashinath","sequence":"additional","affiliation":[{"name":"Shree Siddhivinayak Maternity &amp; Nursing Home  Nasik India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Balamurugan","family":"Ramanathan","sequence":"additional","affiliation":[{"name":"Kovai Diabetes Speciality Centre and Hospital  Coimbatore India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Micky","family":"Patel","sequence":"additional","affiliation":[{"name":"Lotus Multispeciality Hospital  Ahmedabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vivek Vedprakash","family":"Arya","sequence":"additional","affiliation":[{"name":"Smt. 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