The ProblemDiabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar and starches into energy needed for daily life. The cause of diabetes continues to be a mystery, although both genetics and environmental factors such as obesity and lack of exercise appear to play roles. There are 23.6 million children and adults in the United States, or 7.8% of the population, who have diabetes. While an estimated 17.9 million have been diagnosed with diabetes, unfortunately, 5.7 million people (or nearly one quarter) are unaware that they have the disease. It is estimated that there are nearly 250 million diabetics worldwide. The ProductIn addition to its potential as an obesity therapy, Qnexa® may be the first therapy to address Type 2 diabetes as well as weight loss. A phase 2 diabetes study in adults (OB-202) demonstrated a significant reduction in HbA1c from baseline as well as improvements in blood pressure, triglycerides, and waist circumference. The most commonly reported adverse events were tingling, nausea, upper respiratory tract infection, diarrhea, and constipation. DM-230 Phase 2 Trial Highlights:
The results of the DM-230 study include assessments from the start of the OB-202 study through the end of the DM-230 study in this population, for a total treatment period of 56 weeks. Results from this study were presented at the American Diabetes Association's annual scientific session, June 2009. |