15 May 2014

Interim Analysis Suggests that Delivery of Insulin via Valeritas' V-Go® Shows Promise in Improving Glycemic Control for Patients with Type 2 Diabetes Previously Taking Long-Acting Insulin

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Valeritas, makers of the V-Go® Disposable Insulin Delivery Device, announced interim analysis data from SIMPLE, a prospective observational study, today that suggest patients with Type 2 diabetes who switched to V-Go therapy from their previous baseline treatment of long-acting insulin with or without oral medications experienced significantly improved glycemic control and a reduction in total daily insulin dose. The interim results, part of a planned interim analysis performed as part of the twelve month study, were presented at the American Association of Clinical Endocrinologists (AACE) 23rd annual scientific and clinical congress.1

V-Go is a simple, fully-disposable device that delivers a continuous basal rate of insulin for 24 hours with on-demand mealtime dosing. It is designed to be easy to use and assist with blood glucose control in adult patients who require insulin.

"This prospective observational study enables us to obtain data about the actual clinical benefit of V-Go therapy when used in patients previously receiving long-acting insulin in a real-world setting," said Kristine Peterson, Chief Executive Officer. "These interim results are promising, suggesting improved glycemic control by switching patients to V-Go from their long-acting insulin regimen."

Patients with Type 2 diabetes and a baseline A1C greater than 7 percent were enrolled. Study participants were then switched from one of five baseline treatments (5 cohorts) to V-Go for their basal and mealtime insulin delivery.1 One cohort (the basal cohort) included patients previously treated with a long-acting insulin (with or without oral anti-diabetic medication).

The primary objective of the observational study was to compare change of average glycemic control as measured by A1C from baseline to the end of V-Go use for all patients combined as well as each of the individual cohorts. Patients in the study were followed on their previous therapy for up to 6 weeks before initiating therapy with V-Go. The study, observational in nature, had no mandated or forced titration instructions to guide insulin therapy with the exception of recommended starting doses for V-Go basal rate options.1

The interim analysis included 40 patients in the basal cohort with continuous V-Go use for a minimum of 6 months, an average age of 59 years and diabetes for 14 years. At the time of this interim analysis, mean A1C levels for the study participants reduced from a range of 8.5% – 10.2% to a range of 7.7% - 8.3%, depending on the initial V-Go basal dose. In an extended analysis of the overall group, patients in the basal cohort exhibited statistically significant improvements in A1C from baseline to 3 months, 6 months and 9 months of continuous V-Go use, with a p-value of less than 0.001. Five hypoglycemic events occurred (<70 mg />dl). No severe hypoglycemic events were reported. Initiating V-Go therapy after long-acting insulin therapy may be an effective and safe strategy to lower glucose.