Search results
Results from the WOW.Com Content Network
Gestational diabetes is a condition in which a woman without diabetes develops high blood sugar levels during pregnancy. [ 4 ] Type 2 diabetes mellitus and prediabetes are associated with changes in levels of metabolic markers, these markers could serve as potential prognostic or therapeutic targets for patients with prediabetes or Type 2 ...
The glucose clamp technique was developed by University of Texas (UT) School of Medicine Professors DeFronzo, Andres and Tobin in 1979. [2] It has since been the gold standard for pharmacodynamic studies in diabetes drug development and diagnostics evaluation. [3]
Blood glucose monitoring is the use of a glucose meter for testing the concentration of glucose in the blood ().Particularly important in diabetes management, a blood glucose test is typically performed by piercing the skin (typically, via fingerstick) to draw blood, then applying the blood to a chemically active disposable 'test-strip'.
The FDA requires a four-phased series of clinical trials for testing drugs. Phase I involves testing new drugs on healthy volunteers in small groups to determine the maximum safe dosage. Phase II trials involve patients with the condition the drug is intended to treat to test for safety and minimal efficacy in a somewhat larger group of people.
The drug, BMF-219, was being tested in an early-to-mid stage study for type 2 diabetes and a mid-stage study in type 1 diabetes. The drug developer said the FDA cited deficiencies based on the ...
A companion diagnostic (CDx) [1] is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. [2]Companion diagnostics are co-developed with drugs to aid in selecting or excluding patient groups for treatment with that particular drug based on their biological characteristics that determine responders and non-responders to the therapy.
A recent study has shown that people who take SGLT-2 inhibitors for type 2 diabetes management have a 35% lower diabetes risk, overall. A diabetes drug may help prevent dementia, new research ...
The FDA and other regulatory agencies will often accept evidence from clinical trials that show a direct clinical benefit to surrogate markers. [3] Surrogate endpoints can be obtained from different modalities, such as, behavioural or cognitive scores, or biomarkers from Electroencephalography , MRI, PET, or biochemical biomarkers.