In a recent late-stage clinical trial, the results of a new diabetes drug known as “dapagliflozin” were announced in Vienna, Austria, the location of a meeting by the European Association for the Study of Diabetes (EASD). The drug is a sodium glucose co-transporter 2 (SGLT2) inhibitor and is taken once a day to inhibit renal glucose re absorption and assist the kidneys in eliminating glucose through the urine.
Scientists announced that when the medication was given along with metformin, a common diabetes drug, it showed success in lowering glycosylated hemoglobin (hbA1c) and fasting plasma glucose (FPG) levels in type 2 diabetes patients over a 24 week period. The study took 546 patients between the ages of 18 to 77 and the treatment of metformin was not enough to control their blood sugar levels.
A patient’s Glycosylated hemoglobin level usually indicates how much control one has over their blood sugar, while FPG levels demonstrated how well the body can process glucose without food. When both levels are close to normal, this will give a diabetic an increased chance of preventing or delaying complications that may affect eyesight, kidney functions and the nervous system.
Due to the fact type 2 diabetes has grown to affect 246 million people around the world, the potential for drugs that can improve glycemic control and prevent progression of diabetes can be a major step in treatment.
A New Drug Application maybe filed with the U.S. Food and Drug Administration (FDA) in late Q4 this year or early in 2011 and approval would potentially occur approximately 9 months later. By keeping up to date with the latest FDA alerts, drug interactions and drug information about prescription and over the counter medications, we can ensure an environment where patients have the best knowledge on their medical treatment and health.
UPDATE 2012: In January 2012, the FDA decided to not approve Dapagliflozin. The Agency cited cancer and liver damage concerns for people, who took the drug in clinical studies. The FDA is seeking additional trials to determine if the drug is safe.
U.S. Rebuffs AstraZeneca Bristol on diabetes drug, Reuters January 19, 2012.