Insulin Delivery With Valeritas' V-Go® Disposable Insulin Delivery Device Demonstrated Greater Glycemic Control, Less Insulin Utilization and Cost Effectiveness When Compared to Subcutaneous Multiple Daily Insulin Injections

BRIDGEWATER, New Jersey, February 16, 2016 /PRNewswire/ --

Valeritas Inc. announced today the rapid access online publication last week of a retrospective study analysis titled "Clinical and Cost Effectiveness of Insulin Delivery with V-Go^® Disposable Insulin Delivery Device versus Multiple Daily Injections in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin" in Endocrine Practice, the official peer-reviewed journal of the American Association of Clinical Endocrinologists (AACE).  The article was authored by Dr. Rosemarie Lajara, endocrinologist, Diabetes Centers of America, Plano, TX; Dr. Jaime A. Davidson, endocrinologist, University of Texas Southwestern Medical Center, Touchstone Diabetes Center, Dallas, TX; Carla Nikkel, Associate Director, Medical Affairs at Valeritas, Bridgewater, NJ and Dr. Tracy L. Morris, Department of Mathematics and Statistics, University of Central Oklahoma, Edmond, OK.

"The addition of mealtime insulin to intensify insulin therapy is often the next step when patients do not achieve glycemic goals with basal insulin regimens. V-Go delivers basal-bolus insulin coverage and has proven efficacious in previous studies; however an efficacy and cost comparison to other traditional insulin delivery methods had not been evaluated.  We aimed to explore whether insulin delivery with V-Go proved beneficial when compared to subcutaneous multiple daily injections (MDI) in patients with type 2 diabetes inadequately controlled on basal insulin regimens," said Dr. Lajara.

Findings demonstrated a significant decrease in A1C for both insulin delivery methods at 12 and 27 weeks following insulin intensification.  The model adjusted A1C least squares mean (LSM) change (95% CI) at 12 and 27 weeks from baseline was -1.82% (-2.20 to -1.44) and -1.98%
(-2.36 to -1.60) for V-Go and -0.98% (-1.32 to -1.64) and -1.34% (-1.68 to -1.00) for MDI, respectively.  The treatment difference was -0.84% (-1.38 to -0.31, P=0.0023) and -0.64% (-1.17 to -0.10, P=0.0201) at 12 and 27 weeks, respectively, favoring V-Go for both follow-up time points.

Insulin total daily doses compared to baseline were similar for patients transitioned to V-Go from basal insulin and were significantly increased for patients transitioned to MDI.  The model-adjusted LSM change (95% CI) between group difference at 27 weeks for TDD was -31.3 units (-41.5 to -21.1, P<0.0001) and for total basal daily dose was -18.5 units (-26.0 to -11.0, P<0.0001) in favor of V-Go. The direct pharmacy monthly cost inferential associated per 1% A1C reduction with V-Go was significantly less than MDI  ($118.84 vs $217.16; P=0.013).

"Diabetes is a progressive disease which results in the need for intensified insulin therapy for most patients over time.  Consideration for new insulin delivery methods is warranted when clinical and economic benefits can be realized by patients, clinicians and health plans.  In this study, V-Go proved beneficial when compared to multiple daily injections as a method to deliver intensified insulin therapy," concluded Dr. Davidson.

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 continuous preset basal 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.