Planned Trial of Diabetes Drug Avandia Runs Aground

Diabatic Drug
Anti-diabetic drugs treat diabetes mellitus by lowering glucose levels in the blood. With the exceptions of insulin, exenatide, and pramlintide, all are administered orally and are thus also called oral hypoglycemic agents or oral antihyperglycemic agents. There are different classes of anti-diabetic drugs, and their selection depends on the nature of the diabetes, age and situation of the person, as well as other factors.
Diabetes mellitus type 1 is a disease caused by the lack of insulin. Insulin must be used in Type I, which must be injected or inhaled.
Diabetes mellitus type 2 is a disease of insulin resistance by cells. Treatments include (1) agents which increase the amount of insulin secreted by the pancreas, (2) agents which increase the sensitivity of target organs to insulin, and (3) agents which decrease the rate at which glucose is absorbed from the gastrointestinal tract.
Several groups of drugs, mostly given by mouth, are effective in Type II, often in combination. The therapeutic combination in Type II may include insulin, not necessarily because oral agents have failed completely, but in search of a desired combination of effects. The great advantage of injected insulin in Type II is that a well-educated patient can adjust the dose, or even take additional doses, when blood glucose levels measured by the patient, usually with a simple meter, as needed by the measured amount of sugar in the blood.
A large study to test the safety of the controversial diabetes drug Avandia has been put on partial hold by the Food and Drug Administration. The FDA held a hearing on the safety of Avandia last week. Some scientists argue that the drug persistently, if modestly, increases the risk of heart attacks in diabetes patients. But other scientists, as well as the drug's maker, GlaxoSmithKline, challenge those results. The TIDE trial was designed to clear up lingering doubts about the drug but would take at least 6 years to complete. And today, FDA informed Glaxo that it was not allowed to enroll any new patients in TIDE, although patients already enrolled can continue.