Valeritas’ V-Go® Device Shows to Help Improve Compliance and Efficacy for Patients with Diabetes on Insulin + GLP-1 Therapy as well as Those who Switched from Subcutaneous Insulin Injections to V-Go®

Results of two retrospective analyses based on real world data presented in posters at the Diabetes Technology Meeting in Bethesda, Maryland

Oct 22, 2015, 16:00 ET from Valeritas Inc.

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

Valeritas Inc. announced today the results of two new Diabetes America retrospective analyses of real world data about the V-Go® disposal insulin delivery device.  Both analyses were disclosed in posters presented this afternoon at the Diabetes Technology meeting in Bethesda, Maryland by Dr. Rosemarie Lajara, President, Diabetes Centers of America, Physician Associates, P.A. The posters were co-authored by Dr. Lajara and Carla Nikkel, BS, RD, LD, CDE2, Associate Director, Medical Affairs at Valeritas.

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.  V-Go® is available in basal rates of 20, 30 or 40 units and can administer up to an additional 36 units of insulin for mealtime bolus dosing in 2 unit increments, allowing for a total daily dose of 56, 66 or 76 units/day.

The first poster titled, Evaluation of Insulin Delivery with V-Go® Combined with a GLP-1 Receptor Agonist (GLP-1) in Patients with Sub-Optimally Controlled T2DM, evaluated if switching insulin delivery to V-Go® would impact A1C and insulin requirements in patients not achieving glycemic goals with insulin therapy plus glucagon-like peptide-1 (GLP-1) therapy. GLP-1 increases insulin secretion from the pancreas among other effects.

Data was collected from 30 patients with an A1C > 7.0% on insulin injections plus GLP-1 who were willing to switch to insulin delivery using V-Go® while continuing GLP-1 therapy. The results showed significant reductions in A1C and that less insulin was required after an average of three months in patients who had switched to V-Go® for insulin delivery, previously not controlled on GLP-1 therapy plus subcutaneous insulin injections.  A1C reductions from baseline were to -1.6, while the insulin requirements decreased from 112 to 65 units/day.  Patient reported hypoglycemia was similar to baseline.   Improvements have been attributed to efficient insulin delivery with V-Go® as well as the readily available and easily administered bolus dosing. Further studies have been recommended to confirm these results.  

"Basal-bolus therapy coupled with GLP-1 requires patients to administer four or more injections per day. The frequency of injections has been seen to deter patient compliance, which consequently negatively impacts efficacy.  We are very pleased to see that when patients switched their insulin delivery system to V-Go®, not only was there an increase in compliance and efficacy but they also needed less insulin," said Kristine Peterson, CEO of Valeritas.

The second poster titled, Using the V-Go® Disposable Insulin Delivery Device in Patients Prescribed High Insulin Doses: a Comparison of Clinical Results between High and Moderate Insulin Dose Groups, evaluated the clinical impact of the baseline insulin total daily dose (TDD) in patients switching from insulin delivery using subcutaneous insulin injections to V-Go®.   Patients (n=104) were stratified by moderate baseline insulin doses (< 100 u/day) or high baseline insulin doses (≥100 u/day) and compared using TDD u/day and u/kg.  A1C and average prescribed insulin dosing were collected at baseline and at two follow-up visits.  

The results showed significant reductions in A1C and insulin requirements after an average of six months after switching to V-Go® for insulin delivery in patients previously not controlled on basal or basal-bolus subcutaneous insulin injections.  Reductions in A1C were similar between those on < 100 u/day or >100 u/day at baseline (-1.5 and -1.7, respectively).  Also, despite significant differences in baseline insulin doses, both groups had a similar TDD after switching to V-Go® (0.59 and 0.64 u/kg, P=0.25).  Patients prescribed high doses > 100 u/day of insulin experienced comparable A1C reductions administering similar insulin rates on V-Go® to those prescribed moderate insulin doses at baseline.

"We are delighted to have further proof that the V-Go® disposable insulin delivery devices offers patients a practical and effective means to manage their diabetes," concluded Ms. Peterson.

To receive a copy of these posters, please contact, marjierhadad@gmail.com.

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
marjierhadad@gmail.com
+1-908-947-0378


SOURCE Valeritas Inc.