Vivus, Inc, a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health, announced that data from a year-long phase-2 trial (DM-230) evaluating Qnexa in patients with type-2 diabetes are being highlighted in an oral podium presentation at the American Diabetes Association (ADA) 69th Scientific Sessions (abstract 361-OR). The study demonstrated that Qnexa, an investigational new drug, significantly reduced patients' haemoglobin A1c (HbA1c) -- a key indicator of blood sugar control -- and helped patients achieve and maintain significant weight loss. The study also showed that Qnexa had a positive impact on other risk factors associated with diseases prevalent in people living with diabetes.
"While it is widely known that type 2 diabetes can be treated through weight loss, the currently approved weight loss therapies have limitations. The optimal diabetes therapy will not only enable patients to control their blood sugar by lowering glucose levels to the desired range, but will also help patients achieve meaningful weight loss," said W Timothy Garvey, professor of Medicine and Chair of the Department of Nutrition Sciences at the University of Alabama at Birmingham and presenter. "The HbA1c reduction seen in this study of Qnexa is significant. The 9.4 per cent weight loss observed in these patients -- on average more than 20 pounds -- is compelling, not only because of the amount, but more importantly the ability to maintain the weight loss over a year. These results suggest that Qnexa has the potential to play an important role in diabetes management with respect to blood sugar control and sustained weight loss."
Overall, the study had a greater than 90 per cent completion rate. All results were evaluated based on an intent-to-treat population using the last observation carried forward, known as ITT-LOCF, the method of analysis required by the US Food and Drug Administration.
"Type-2 diabetes is a challenging disease to manage for clinicians and patients alike, especially given the high incidence of co-morbid conditions associated with the disease," said Leland Wilson, president and chief executive officer of Vivus. "The study results we have seen thus far across the clinical development programme for Qnexa reinforce Qnexa's potential in the treatment of type-2 diabetes, and, importantly, in treating co-morbidities including high blood pressure. During last year's ADA meeting, we showed that type-2 diabetics were able to lower their blood sugar and lose weight after six months of treatment with Qnexa. The DM-230 study confirms our original findings and shows continued improvement in blood sugar and sustained weight loss for one year in this difficult-to-treat population."
"Qnexa has shown very promising data to date as a potential therapy to treat obesity in type-2 diabetic patients. This is exciting as it addresses one of the main etiologies of type-2 diabetes -- the weight. This study in a real-world population of type-2 diabetics, applied on a background of rigorous standard of care treatment, shows the true potential of Qnexa in this population," stated Barbara Troupin, Clinical Leader for Qnexa Diabetes.
Qnexa is a proprietary, low dose, controlled release formulation of phentermine and topiramate that simultaneously addresses both appetite and satiety -- the two main mechanisms that impact eating behavior -- in one daily capsule. Qnexa, an investigational drug, is an obesity therapy being developed to address type 2 diabetes as well as obesity.
Vivus is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health.