Valeritas Announces The Publication Of A Retrospective Analysis Of Patient-Reported Data On The V-Go In The Current Issue Of Endocrine Practice

BRIDGEWATER, N.J., Nov. 12, 2012 /PRNewswire/ -- Valeritas announced today the results from a recent retrospective analysis that looked at data relating to the clinical experience and feedback of patients with Type 2 diabetes who used the V-Go™, a wearable device for the delivery of insulin. The retrospective analysis of self-reported data from V-Go patients has been published in the current issue of Endocrine Practice, a peer-reviewed journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists. Results from the analysis showed that V-Go helped patients to improve their glycemic control, and patients also reported a positive overall experience with regard to their general satisfaction, mealtime insulin compliance, and comfort while on the V-Go.

The goal of the retrospective analysis was to review patient impressions of the V-Go. When rating their overall experience with V-Go on a scale from 1 to 10, with 10 being the most positive, the mean patient rating was 9.1 at 12 weeks of treatment. The average ratings rose through weeks 4, 8 and 12 for all baseline insulin regimen subsets.¹ Reviewers of the retrospective analysis data also noted that despite a slight decrease in total daily insulin dose while on the V-Go, patients had a lower A1c -- reviewers discovered that patients had a mean decrease in A1c from 8.8 percent to 7.6 percent while using the V-Go. Reviewers also found that following discontinuation of V-Go use, patients A1c rose to 8.2 percent.

"Patient feedback showed the V-Go was simple to use, discreet and comfortable to wear. In addition, the retrospective analysis indicated that V-Go use generally helped patients to improve glycemic control and a decrease in A1c," said Cheryl Rosenfeld, DO, FACE, FACP, lead author of the study and Clinical Assistant Professor of Medicine at the New York College of Osteopathic Medicine. "These attributes of the V-Go may have led to better adherence to a relatively complex dosing regimen, which helped patients better control their blood glucose."

Researchers conducted a prospective data collection from a retrospective analysis of 23 V-Go patients, all of whom were previously treated with insulin using pens or syringes. Patients using the V-Go answered telephone surveys about their perception of device use and the corresponding clinical data were retrospectively collected from before V-Go initiation, after 12 weeks of use, at the end of treatment, and 12 weeks after discontinuation. Patients filled out questionnaires about the functionality of the V-Go, including their opinion of the device, at interim stages of treatment.¹

"Nearly two-thirds of insulin users do not achieve their recommended target glucose levels. The V-Go mimics the body's natural insulin pattern and helps enable patients to take control of their glucose levels and improve compliance," said Kris Peterson, CEO of Valeritas, Inc. "These results help demonstrate  the clinical value of the V-Go, which not only help improve diabetes management, but has also shown to be a patient preferred method for insulin delivery."

For more information about V-Go, or to find out if V-Go is right for you, call 1-866-881-1209. Customer Care Representatives are available 24 hours a day, seven days a week or visit www.go-vgo.com or www.valeritas.com.

About Diabetes

In order to fuel the human body's cells with glucose, or sugar, insulin is required. While the body continuously produces insulin, people with type 2 diabetes, the most common form of diabetes, either do not produce enough insulin, or their bodies cannot use the insulin adequately. When there is not enough, or insulin is not used properly, glucose builds up in the blood instead of going into the body's cells. If not controlled properly, diabetes can increase the risk of heart disease, blindness, amputations, stroke, and high blood pressure.

The number of patients diagnosed with diabetes in the United States is alarming and continues to grow. According to the American Diabetes Association, nearly 26 million people in the United States have diabetes,² with approximately 4.5 million depending on daily insulin injections to help them control and manage their diabetes.³ However, more than half of insulin users do not achieve their recommended target glucose levels for various reasons, including injection pain, or the embarrassment of injecting medication in public.

About the V-Go Disposable Insulin Delivery Device

The V-Go is a simple, fully-disposable device designed and cleared for the delivery of basal-bolus insulin therapy for adults with diabetes. The V-Go delivers a continuous preset basal rate of insulin and allows for on-demand bolus dosing at mealtimes, providing insulin 24 hours per day. Valeritas has received both FDA 510(k) clearance and European CE Mark certification for the V-Go.

Patients fill the V-Go with insulin using a simple, disposable, point-of-care filling accessory ― the V-Go™ EZ Fill (which will be included with each monthly supply of V-Go devices). A separate prescription for insulin is required for use with the V-Go. Humalog® and NovoLog® have both been tested by Valeritas, Inc. and found safe for use with the V-Go.

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 the 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. The V-Go should be removed before any magnetic resonance imaging (MRI) testing.

About Valeritas, Inc.

Valeritas is a medical technology company committed to the development and commercialization of innovative drug delivery solutions with the primary focus of treating patients with Type 2 Diabetes.

The Valeritas portfolio is headlined by the V-Go™ Disposable Insulin Delivery Device, designed for the simple delivery of basal-bolus insulin therapy via a preset basal rate and on-demand bolus dosing at mealtimes. The V-Go offers an alternative for many Type 2 diabetes patients who find it difficult to take insulin injections as scheduled throughout the day.

Valeritas is dedicated to providing impactful solutions for the millions of patients diagnosed with Type 2 diabetes in the United States - a population that continues to grow at an alarming rate.  According to the American Diabetes Association, nearly 26 million people in the US have Type 2 diabetes,² and approximately 4.5 million people depend on daily insulin injections to help them control and manage their diabetes.³

In addition to V-Go, Valeritas' delivery technology portfolio includes the h-Patch™ for the delivery of other compounds beyond insulin, the Mini-Ject™ Pre-Filled Needle-Free Delivery System, and the Micro-Trans™ Microneedle Transdermal Delivery Patch.

Headquartered in Bridgewater, New Jersey, Valeritas operates its R&D and manufacturing in a state-of-the-art facility in Shrewsbury, Massachusetts. For more information, visit www.valeritas.com.

REFERENCES

¹  Rosenfeld CR, Bohannon NJ, Bode B, et al. The V-Go Insulin Delivery Device Used in Clinical Practice: Patient Perception and Retrospective Analysis of Glycemic Control. Endocrine Practice. 2012; 18 (5):660-667.
²  American Diabetes Association, Diabetes Basics. http://www.diabetes.org/diabetes-basics/diabetes-statistics/?loc=DropDownDB. Published 2012. Accessed October 18, 2012.
³  National Diabetes Information ClearingHouse. National Diabetes Statistics. 2011. http://diabetes.niddk.nih.gov/dm/pubs/statistics/#fast. Accessed September 5, 2012.

SOURCE Valeritas, Inc.