The device releases a single type of insulin at a continuous preset basal rate over a 24-hour period to allow patients to mimic the body’s normal physiologic pattern of insulin delivery.

It also provides on-demand bolus dosing at mealtimes with U-100 fast acting insulin.

Under the first analysis, Valeritas assessed if switching insulin delivery to V-Go would effect A1C (a measurement of glucose control) and insulin requirements in patients that do not achieve glycemic targets with insulin therapy and glucagon-like peptide-1 (GLP-1) therapy.

The company gathered data from 30 patients with an A1C greater than 7% on insulin injections and GLP-1.

Valeritas said the results demonstrated significant reductions in A1C and less insulin was needed, three months after switching to V-Go.

In the second study, the company evaluated the clinical impact of the baseline insulin total daily dose in patients switching from insulin delivery using subcutaneous insulin injections to V-Go.

A1C and insulin requirements were reduced following an average of six months after switching to V-Go in patients previously not controlled on basal or basal-bolus subcutaneous insulin injections.

Valeritas CEO Kristine Peterson said: "Basal-bolus therapy coupled with GLP-1 requires patients to administer four or more injections per day. The frequency of injections has been seen to deter patient compliance, which consequently negatively impacts efficacy.

"We are very pleased to see that when patients switched their insulin delivery system to V-Go, not only was there an increase in compliance and efficacy but they also needed less insulin."

The device received FDA 510(k) Clearance in 2010 and the European CE Mark approval a year later.

Image: Valeritas’ V-Go device enables patients to administer a continuous, preset basal rate of insulin over 24 hours. Photo: courtesy of Valeritas, Inc.