> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Labeling Changes for Merck Diabetes Drugs
- URL: https://www.fdaweb.com/labeling-changes-for-merck-diabetes-drugs/
- Published: 2020-12-04T12:00:00.000Z
- Updated: 2026-09-14T16:39:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148236

FDA has approved labeling changes stating that Merck’s [Januvia](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f97KHcaOOQ7u-2FaCjWJGOMNseOmO8gEl6SYs-2FDXcI1vvll98MimjFL8CeBXKlTveebYHU3ufmS6atjXDwIIroZjnQRG6XqNnPXoI1q73lN4FRWTPjeaUHFPRwENdXUpoR8jxX9QP4r-2BF2FK-2FZRywq6FznEJzCRv1HX0qFSEI9Uxc6dC1c4fkmlAj4U-2BfPKi5qMpYubNPst4hNoj8jGyylT4flbfWtYgGkPJuJMFkoqFoFtfn-2B2JJqPqpPDscbOAUWJMuCiBXzuHQ6a1QsQzQn98WMmIGG0Kz7YFDdMfuGtCtd-2BmbS-2FozHq1JEcsmhWtLEZdoZZSZf6T1RH9Bm3u0oFSXVpAT1Q8aLt1sWXgu-2BUzs-2F0QHgSFjI0rtDprapURtHfFmotcK34UhL-2B3N9cZh1-2Bl9xL36iZT54Jult3Xvbu1tQ4wM5MD2ACBkDFMw-2F8zKaeOg-3D-3DB6CN%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N8lwrOmpeVIIo-2BHFGAEpjIQYTcxMAeeCFbWb5Y7c69vMfsw9h82hkIjXUA5TAqeuuoAspdmYLBzonGFzPezZaaEtu-2F-2BnswROYmIFG-2BjFoj-2F5SljQQJJsY77SXpTJG4cB-2Fi8-2F4fj4zqj5MjieYTe-2F-2Fz4NvFwe6J9RhBxipTBmVFlE8QErrpHrAhTGN7gPISI21YpHSn0yyZR1ZZall85ooj9bCGhSMLRuM54MMsT-2FdPVKzASEpZ3KorYeh7NhpDda5A-3D&ref=fdaweb.com) (sitagliptin), [Janumet](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f9wgMAtjLAQrGivegWKtTaBdi73g83EDm7rf5ZEqUt9SYJyzPPGDOjsmR46CptDfKppSGRCSjzkpL9I07maP8OWp0KlVWHKXGhUDM9AuzsyQr-2BO1E2hUUNVU1EMWPOGLy6Ry-2BA8D1JVeKp6F3PkBZ-2F9XPDt97Z6SwT9rhVT2UNJxqw9PbNMvNZtCC4tw1ykOH7ut3QFwODKtjsrp3oyPYH4OowGgaNWKUtociEAcCFeOrv8W9s5IoFIn6ObM6rlN16EBZdeLVH0-2BARZY7RPknBQzjBgJrAP6uze9lIrfIphalweHJupgm-2FUNQ6KZBDuEN3Fj1Nad-2B-2BPL3mAXvTM8uXKM2GYUBJYgYYx3D1Kwd1-2FkVN7X0-2BK1NfuTNBNeRuiq8k-2FRiOqXwhiUC-2FarSY5meubJPehU92j7KY3ZjRErxmZHkeNsJtQuA0n5j2NUhgjgZdQ-3D-3DZJZ6%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N8lwrOmpeVIIo-2BHFGAEpjIQYTcxMAeeCFbWb5Y7c69vMfsw9h82hkIjXUA5TAqeuuoAspdmYLBzonGFzPezZaaEH18QmIkX-2Bh4TDFFGjxvQN8jfFYjYuh-2Bftxh-2Fv7WBf7U7NlKJ3j4ZOtPsRnTiTnqJ6G3H5-2FD1D8EqXI1YxJmOQ0dGA4IVlQ25QnFuP5I-2FT1JAbpmXJEHjfngxEtBfnugP4DIlQmG7b56-2BAXO3h4ReOwPy2TBATLMZ-2FrfEJJignLc-3D&ref=fdaweb.com) (sitagliptin and metformin hydrochloride), and [Janumet XR](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f973R7vJtoFQ73dqeKdq4yGLwA1FCts1mZyHoN8QrF36f12RrmKPK2OO-2FWOTJcavJU4-2B-2Bwz2fcYBsEi0iR0gG3bSL0EhUT3GaN6i9qKxNr9DvXGsWEyPhb-2Bf8navqrBTDSSazfTzg5Jp15Uf3I8DQMN8djeaDBYADn5kW9ykipQFjKw9JzQGU7ymQ2BLKBIMNP5huvP6SXr-2BKhVMRwtac1VhvfytqSox9iC1-2Fk0tBLa46Zsyur-2BLdX7WNYq4FiSlIfZXXd6JxKSoJeBHlfep0dcRSA88uApDe2xGfzJYUjrNhuhkb-2FjGp8XCvVrynSkAqeq9AiMGHMOtaNYh7lDVT60nSSFfE-2FdocEcAd6vFKiFO-2Bn2jGt9jFIa1WOxxxs9F5Fd3PJxQ2uhjQB6spTpVZie8ccbg0S5vFwatjkwb-2BzJMthkwkCzbyCwsGyYFIYmTwJg-3D-3D3cjH%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N8lwrOmpeVIIo-2BHFGAEpjIQYTcxMAeeCFbWb5Y7c69vMfsw9h82hkIjXUA5TAqeuuoAspdmYLBzonGFzPezZaaEJqSvO6DLYcOa7ChKhIO-2FNfB1Wq7LEUABVHfMLVnPF-2FbBriJGP5lCLBjLFoLISo1zPZcJiECYyqE-2B6150Dtl-2BgN6zcNovSpyUXlkuAUC2oyiXzHnrbxJx76-2BAN0T4eaUlO3I0-2BYPmOUFdojOt-2FUwjVJwPdRbogUZu92o9Q8UDYn0-3D&ref=fdaweb.com) (sitagliptin and metformin hydrochloride extended-release) are not proven to improve glycemic (blood sugar) control in pediatric patients age 10 to 17 with Type 2 diabetes . The drugs are approved to improve blood sugar control in adults age 18 and older with Type 2 diabetes. The [labeling changes](https://www.fda.gov/drugs/drug-safety-and-availability/new-studies-show-diabetes-drug-not-proven-improve-blood-sugar-control-pediatric-patients?utm%5Fmedium=email&utm%5Fsource=govdelivery) are based on data from three double-blind, placebo-controlled studies showing that patients receiving sitagliptin did not have a significantly different glycemic control than those taking placebo.