Valeritas Places Top 3 Out of 240 Posters in AACE’s General Poster Competition
Poster reports real-world study data demonstrating that Valeritas’ V-Go® reduces A1C and lowers the Daily Insulin Dose for patients with Diabetes
BRIDGEWATER, N.J., June 4, 2015 – Valeritas announced today that a poster reporting real-world clinical findings about V-Go®, finished in the top 3 in the general poster competition at the 2015 American Association of Clinical Endocrinologists’ (AACE) Annual Scientific and Clinical Congress in Nashville, Tennessee.
The award winning poster is titled Evaluating the Effect of V-Go® Therapy in Sub-Optimally Controlled Patients with Diabetes: A Retrospective Cohort Analysis in a Large Specialized Diabetes System. The poster detailed the real-world study data collected from electronic records and the corresponding retrospective analysis reported by Diabetes America on Valeritas’ lead product, V-Go. The poster, first announced in a press release dated May 15th, was presented by Dr. Rosemarie Lajara, president, Diabetes of America, Physician Associates, P.A. Dr. Lajara accepted the award during a ceremony at the meeting.
“It is an honor and a privilege to receive this award from the AACE. We congratulate the other winners and acknowledge the important work of all of our colleagues who were accepted to present in the general poster session,” said Dr. Lajara.
According to the AACE, “There were approximately 240 posters in the general poster session. Presenters did not need to apply to be considered, it is automatic with the acceptance for poster presentation by the 2015 AACE Annual Meeting Poster Judges. Thereafter, expert judges from AACE leadership and committees reviewed the posters for originality, scientific/clinical relevance, visual appeal, organization, and author’s presentation. Scores were submitted and tabulated to determine the winners.”
The award-winning poster evaluated the effects of switching patients sub-optimally controlled on their current regimen to V-Go. As the study was conducted in a real-world clinical setting, neither patients nor providers were compensated to participate. Patients followed normal clinical practice where there were no required physician office visits, mandated treatment protocols or forced titration algorithms. Patients were also responsible for obtaining all prescribed therapies.
One hundred and fifty-three patients were evaluated. Patients were either previously on multiple daily insulin injections (MDI), long-acting basal insulin therapy (Basal), or were naïve to insulin at baseline (Naïve). Follow up data were collected for each subsequent visit where an A1C value was recorded. Data demonstrated that all cohorts experienced significant (p<0.0001) improvements in glycemic control on v-go. the mean a1c change from baseline across the entire cohort was -1.7%. a reduction in fasting plasma glucose (192 to 146 mg />dl) was observed in patients previously receiving only Basal Insulin injections (+/- oral medications) at baseline despite a 33% to 41% reduction in daily basal insulin dose.
For those patients previously on insulin, the prescribed total daily dose also significantly decreased from the amount prescribed before switching to V-Go therapy. Patients previously on multiple daily injections experienced a 31% to 48% reduction from baseline insulin total daily dose which was maintained up to 6 months.
Dr. Lajara continued, “We are encouraged by the impressive results which show that patients with various types of diabetes can significantly benefit from V-Go, in terms of improved glycemic control as well as overcoming other common barriers to successful insulin treatment.”
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 www.valeritas.com.
Press Contact:
Marjie Hadad
MH Communications
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908-947-0378