Real-World Study Data Demonstrating That Valeritas' V-Go Consistently Reduces A1C Levels and Decreases Insulin Requirements for Patients With Diabetes Regardless of Baseline A1C Presented at ADA 2015

BRIDGEWATER, New Jersey, June 8, 2015 /PRNewswire/ --

Valeritas Inc. announced today additional real-world study data and retrospective analyses reported by Diabetes America on Valeritas' lead product, the V-Go^® Disposable Insulin Delivery Device. The data, collected from electronic records, and the analyses were disclosed in poster presentations at the American Diabetes Association (ADA) 75^th Scientific Session in Boston, Massachusetts. The posters presented at ADA complement and strengthen the scientific data and associated analyses recently disclosed in posters at AMCP 2015 and AACE 2015.

V-Go is a simple, wearable, basal-bolus insulin delivery solution for patients with diabetes that enables patients to administer a continuous, preset basal rate of insulin over 24 hours and provides on demand bolus dosing at mealtimes with U-100 fast acting insulin.  

One poster, titled Glycemic Effect with V- Go^® Based on Baseline Hemoglobin A1C,  

evaluated the changes that occurred when switching patients with diabetes to V-Go.  Data was collected from 151 patients, with an average age of 52 years and known duration of diabetes of 14 years. Patients were stratified by baseline A1Cs into three groups.  The results showed that switching patients to V-Go provided a simple way to deliver basal bolus insulin therapy and resulted in significant A1C reductions on less insulin, across the board, regardless of baseline A1C, with the greatest improvements of more than a 3% decrease in patients with the highest A1C's.  

"These results are truly significant and encouraging. Patients with diabetes, regardless of baseline A1C, experienced an improvement using V-Go both in terms of glycemic control as well as lowering the amount of insulin required.  We are very pleased that V-Go made a clear and positive difference in the well-being of patients with diabetes in a real-world clinical setting," said Valeritas CEO Ms. Kristine Peterson.    

Another poster, titled Improved Glycemic Control and Reduced Insulin Requirements Over Time with V-Go^® in Patients with Diabetes, documented a retrospective analysis evaluating the change in glycemic control and insulin dosing for patients unable to achieve glycemic control using other therapies. Information was collected on 72 patients with an average age of 53 years, all who were switched to V-Go and had a minimum of three follow-up A1C values.  Results showed, that for 9 months, significant A1C results were maintained while using up to 40% less insulin from baseline.

Ms. Peterson continued, "Normal study follow up takes place at three and six months post baseline. And, we have seen impressive results at both junctures. Of significance, the new longer term data shows results consistent with previous findings.  This is further proof that V-Go encourages patient acceptance and compliance as well as helps patients to enjoy the associated benefits of V-Go both in the short and longer term."

To receive a copy of these posters, please contact, [email protected].

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 the first, 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.

Press Contact:
Marjie Hadad
MH Communications
[email protected]
+1-908-947-0378

SOURCE Valeritas Inc.