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Drugs used in diabetes treat types of diabetes mellitus by decreasing glucose levels in the blood. With the exception of insulin , most GLP-1 receptor agonists ( liraglutide , exenatide , and others), and pramlintide , all diabetes medications are administered orally and are thus called oral hypoglycemic agents or oral antihyperglycemic agents.
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Sotagliflozin (Inpefa) is a dual SGLT1/SGLT2 inhibitor approved by the US Food and Drug Administration (FDA) in May 2023, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.
The main goal of diabetes management is to keep blood glucose (BG) levels as normal as possible. [1] If diabetes is not well controlled, further challenges to health may occur. [1] People with diabetes can measure blood sugar by various methods, such as with a BG meter or a continuous glucose monitor, which monitors over several days. [2]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Self-injected drugs are especially difficult for people with vision or motor difficulties, which are common in people with type 2 diabetes. [29] Attempts to develop an orally bioavailable GLP-1 agonist, either a modified peptide, as in the case of oral semaglutide, [ 37 ] or a small molecule drug, have produced additional drug candidates. [ 28 ]
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