BRIDGEWATER, New Jersey, January 18, 2016 --- Valeritas Holdings, Inc. (OTCQB: VLRX) today announced the publication of study results reflecting real-world clinical practice showing that nursing home residents with type 2 diabetes who used the V-Go® Insulin Delivery device had improved glycemic control compared to residents who received insulin via traditional injections with syringes or pens. Use of V-Go was also associated with reduced nursing staff time and labor costs for insulin administration. The study was published in the January 2017 print issue of the Journal of Gerontological Nursing (43(1): 10-16).
“We have consistently shown in numerous studies that V-Go simplifies insulin administration for patients with type 2 diabetes and results in better glycemic control, reduced insulin dose and lower costs compared to insulin delivery with insulin pens,” said John Timberlake, President and Chief Executive Officer of Valeritas. “Although the company does not currently promote V-Go in nursing homes, this study shows that the advantages of V-Go can be translated into a long-term care setting with the additional advantage of reducing labor costs in these institutions.”
The study was a retrospective chart review of patients with type 2 diabetes who resided in a single nursing home and who were receiving basal and bolus insulin via syringes or pens (standard of care or SOC) to manage blood glucose levels. Patients were included in the V-Go group if they had used V-Go during a six-month timeframe. V-Go patients were matched to SOC patients based on their mean 30-day blood glucose (BG) measures at baseline. The primary endpoint was the proportion of BG time in the range of 100 mg/dL to 200 mg/dL, which reflected the target glycemic range of older adults with complex health status. Secondary endpoints included mean daily BG measurements, glycemic fluctuations and excursions and the number of daily injection sites.
After 61 days of follow up a significantly higher proportion of BG measurements were in the target range for the V-Go group vs. the SOC group (59% vs. 34%, p<0.001). For the secondary endpoints, a lower daily mean BG was observed in the V-Go group (159.4 mg/dL vs. 223.9 mg/dL, p<0.001), hyperglycemic excursions were lower in the V-Go group (23.2% vs. 56.8%, p<0.001) and the mean number of unique daily injections sites were lower in the V-Go group (1.0 vs. 6.4). In addition, the calculated A1c in the V-Go group was reduced from 8.9% to 7.2% whereas it increased from 9.0% to 9.1% in the SOC group. Nursing staff time to administer insulin was decreased by 26 minutes per patient per day resulting in a calculated reduction in insulin administration costs of $328.75 per patient per month.
“Management of nursing home residents with type 2 diabetes can be quite complex and require significant staff time,” said Brenda Balinski, RN and Director of Nursing at The Meadows Nursing and Rehabilitation Center. “I am grateful for the experience I had with V-Go and the clinical study. There is a lot to be said for better control of diabetes in the elderly.”
About Valeritas Holdings, 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, V-Go® Disposable Insulin Delivery device, is a simple, wearable, basal-bolus insulin delivery device for patients with type 2 diabetes that enables patients to administer a continuous preset basal rate of insulin over 24 hours. It also provides discreet on-demand bolus dosing at mealtimes. It is the only basal-bolus insulin delivery device 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 Shrewsbury, Massachusetts. For more information, please visit www.valeritas.com.
Forward Looking Statements
This press release may contain forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Valeritas technologies, business and product development plans and market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue Valeritas’ business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize the V-Go® Disposable Insulin Delivery device with limited resources, competition in the industry in which Valeritas operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and Valeritas assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Valeritas files with the SEC available at www.sec.gov.
