Real-World Data from Three Separate Studies Demonstrate that Valeritas' V-Go® Significantly Reduces A1c and Lowers Total Daily Insulin Dose for Patients with Diabetes

BRIDGEWATER, New Jersey, May 15, 2015 /PRNewswire/ --

Valeritas Inc. announced today the real-world study data and retrospective analyses reported by Diabetes America on Valeritas' lead product, V-Go. The data, collected from electronic records, and the analyses were disclosed in three separate poster presentations at the American Association of Clinical Endocrinologists' (AACE) 24th Annual Scientific and Clinical Congress in Nashville, Tennessee.

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 one insulin.  

"What is important about the information presented at AACE is that it offers an assessment of data taken from patients in a real-world, clinical setting. Participating patients and providers were not compensated to be in a study and the treatment of patients followed normal clinical practice where there were no required physician office visits, mandated treatment protocols or forced titration algorithms. Moreover, patients were responsible for obtaining all prescribed therapies," said John Timberlake, president and chief commercial office at Valeritas.

The first study, 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, evaluated the effects of switching patients sub-optimally controlled on their current regimen to V-Go. 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 three cohorts experienced an improvement in glycemic control on V-Go. For those patients previously on insulin, the prescribed total daily dose also significantly decreased from the amount prescribed before switching to V-Go therapy.  

The A1c changes at the 1^st and 2^nd follow-up visits (approximately 3 and 6 months) were: All patients (-1.7% [-2.0, -1.4], -1.8% [-2.1, -1.5]); patients receiving multiple daily insulin injections at baseline (-1.2% [-1.5, -0.89], -1.2% [-1.6, -0.86]); patients receiving basal insulin at baseline (-1.9% [-2.4, -1.5] -2.3% [-2.8, -1.7]); and, patients naïve to insulin at baseline (-3.1 [-4.0, -2.3], -3.3 [-4.2, -2.4]). Regarding total daily insulin dose, MDI and Basal patients experienced a 31% to 41% reduction from the amount of insulin administered compared to the amount prescribed at baseline.

"Insulin has proven to be one of the most potent agents available to lower blood glucose levels. Insulin intensification, although needed, can be delayed due to fears, complexity, and inconvenience by both patients and prescribers," said Dr. Rosemarie Lajara, president, Diabetes Centers of America, Physician Associates, P.A.  "We have found V-Go most importantly provides a significant glycemic benefit to a wide range of patients but also addresses many of the barriers to insulin by offering a simple and physiologic option for insulin delivery."    

In the second poster, the safety and efficacy of V-Go was investigated in 21 patients with latent autoimmune diabetes in adults (LADA) or with type 1 diabetes (T1DM), with elevated blood glucose levels. All participants switched from a standard multiple daily insulin injection regimen to V-Go. The results were presented in a poster titled, Experience using V-Go in Patients with Latent Autoimmune Diabetes of the Adult (LADA) or Type 1 Diabetes.  Data demonstrated that after switching to V-Go these patients experienced significant A1c reductions and decreased insulin requirements. This is the first time data on the specific use of V-Go by patients with LADA or T1DM has been presented.

"While V-Go is indicated for use with adults who require insulin, which includes LADA and Type 1 diabetes, Valeritas has not been actively promoting it to this patient population. Nevertheless, these results show promising opportunities for patients who are able to use a preset basal rate of insulin and at least 2 units of bolus dosing at a time," said Mr. Timberlake.

The third poster, Utilization of Regular Insulin in V-Go^® for Patients Uncontrolled with Type 2 Diabetes Mellitus (T2DM): A Case Series, reports and analyzes data collected from two patients, both 65+, with poorly controlled type 2 diabetes. The purpose of this analysis was to begin determining the effectiveness of regular insulin when delivered using V-Go. After switching from their previous insulin regimen to V-Go, both patients experienced improved glycemic control and reduced their total daily insulin requirements.

"We are very enthusiastic about the data announced today at AACE. It is clear that using V-Go positively impacts the daily lives of patients with diabetes. In each analysis, there was a statistically significant reduction in A1c and lowering of total daily insulin needs. We are also particularly encouraged since these data are shown in a real-world setting. Our goal is for all patients who could benefit from V-Go to enjoy the same experience," said Valeritas CEO Ms. Kristine Peterson.

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.

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SOURCE Valeritas Inc.