Valeritas’ V-Go® Disposable Insulin Delivery Device Demonstrates Efficacy and Safety in Patients with Diabetes

BRIDGEWATER, New Jersey, October 22, 2015 /PRNewswire/ --

Valeritas Inc. announced today the publication this week of an article titled "Use of V-Go^® Insulin Delivery Device in Patients with Sub-optimally Controlled Diabetes Mellitus: A Retrospective Analysis from a Large Specialized Diabetes System" in Diabetes Therapy, an international, peer-reviewed journal.  The article was authored by Dr. Rosemarie Lajara, endocrinologist, Diabetes Centers of America, Plano, TX, Dr. Dianne A. Fetchick, endocrinologist, Diabetes Centers of America, San Antonio, TX, Dr. Tracy L. Morris, Department of Mathematics and Statistics, University of Central Oklahoma, Edmond, OK and Carla Nikkel, Associate Director, Medical Affairs at Valeritas, Bridgewater, NJ.

"Tight glycemic control and timely treatment can improve outcomes in patients with diabetes, yet many remain sub-optimally controlled.   Basal insulin therapy is sufficient for many patients; however despite optimization of basal insulin evidence suggests less than 40% of patients with type 2 diabetes achieve glycemic targets. Previous studies have reported that patients using the V-Go^® Disposable Insulin Delivery device experience improved glycemic control with favorable patient acceptance. We aimed to explore these earlier findings by evaluating patient outcomes in our diabetes centers, located across Texas," said Dr. Lajara.

The records of two-hundred and four patients with sub-optimally controlled diabetes, glycated hemoglobin (A1C) >7%, who had switched to V-G were assessed.  Blood glucose control (defined as change from baseline  A1C), prescribed insulin doses, body weight, concomitant anti-hyperglycemic agents, and patient reported hypoglycemia prior to switching to V-Go and during V-Go use were collected.

Data demonstrated a significant decrease in A1C after switching to V-Go at the 14- and 27-week follow-up visits. The least-squares mean (LSM) change in HbA1c (95% confidence interval) from baseline to 14 weeks was -1.53% (-1.69% to -1.37%; P<0.001), and from baseline to 27 weeks was -1.79% (-1.97% to -1.61%; P<0.001). Significant reductions in mean A1C were achieved at both visits in all patient subsets: Patients with type 2 and type 1/latent autoimmune diabetes in adults (LADA); patients using insulin at baseline and patients naïve to insulin at baseline. Patients administering insulin at baseline required significantly less insulin on V-Go (86-99 LSM units/day at baseline to 58 LSM units/day at 27 weeks; P<0.001). Across all patients, reported hypoglycemic events were no more frequent on V-Go than on previous therapy.

"The study results show that V-Go is safe and effective in patients with sub-optimally controlled diabetes requiring insulin therapy. Glycemic control improved significantly, less insulin was required, and hypoglycemic events were similar after patients switched to insulin delivery by V-Go^®," concluded Dr. Lajara.

About the V-Go^® Disposable Insulin Delivery Device

V-Go is a small, discreet, wearable and easy-to-use disposable insulin delivery solution for the delivery of basal-bolus insulin therapy in adults with Type 2 diabetes. V-Go enables patients to closely mimic the body's normal physiologic pattern of insulin delivery by releasing a single type of insulin at a continuous preset basal rate over a 24-hour period and also providing for on-demand bolus dosing at mealtimes. V-Go is mechanical and operates for 24 hours without electronics, batteries, infusion sets or programming. It is worn on the skin under clothing and measures just 2.4 inches wide by 1.3 inches long by 0.5 inches thick, weighing approximately one ounce when filled with insulin

Important Risk Information: If regular adjustments or modifications to the basal rate of insulin are required in a 24-hour period, or if the amount of insulin used at meals requires adjustments of less than 2-Unit increments, use of the V-Go Disposable Insulin Delivery device may result in hypoglycemia. The following conditions may occur during insulin therapy with V-Go: hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). Other adverse reactions associated with V-Go use include skin irritation from the adhesive pad or infections at the infusion site. V-Go should be removed before any magnetic resonance imaging (MRI) testing.

About Valeritas, Inc.

Valeritas is a commercial-stage medical technology company focused on developing innovative technologies to improve the health and quality of life of people with Type 2 diabetes. Valeritas' flagship product, the V-Go, is a , simple, wearable, basal-bolus insulin delivery solution for patients with Type 2 diabetes that enables patients to administer a physiological, continuous, preset basal (continuous) rate infusion of insulin over 24 hours. It also provides on-demand bolus dosing at mealtimes.  It is the only basal bolus insulin delivery system on the market today specifically designed keeping in mind the needs of type 2 diabetes patients. Headquartered in Bridgewater, New Jersey, Valeritas operates its R&D functions in a state-of-the-art facility in Shrewsbury, Massachusetts. For more information, please visit http://www.valeritas.com.

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SOURCE Valeritas, Inc.