Clinical Trial Evaluating Delivery of Regular Human Insulin Vs. Rapid Acting Insulin Delivered by Valeritas Holdings, Inc.’s V-Go® Meets Primary A1c Endpoint
August 15, 2019 at 12:00 pm
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Valeritas Holdings, Inc. announced that a randomized controlled trial comparing the delivery of U-100 Regular Human Insulin (RHI) by V-Go versus delivery of Rapid Acting Insulin (RAI) by V-Go in patients with type 2 diabetes has met the primary A1c (blood sugar levels) endpoint. A planned interim analysis was reviewed by an independent Data Safety and Monitoring Committee (DSMC) who unanimously recommended stopping further participant screening and randomization after determining non-inferiority had been met when examining the change in A1c over the treatment period between the two arms. The DSMC concluded that the data collected after 75% of the patients had been randomized was sufficient to support the conclusion that the study had successfully achieved the study’s primary endpoint. Because no untoward safety signals were seen, the investigators agreed on August 12, 2019 to end the study early. At this time the use of U-100 Regular Human Insulin with V-Go Wearable Insulin Delivery device has not been cleared by the Food and Drug Administration. A U-100 fast acting insulin should be used with V-Go. Humalog® (insulin lispro, rDNA origin) and NovoLog® (insulin aspart, rDNA origin) have been tested by Valeritas, Inc. and found to be safe for use in the V-Go Wearable Insulin Delivery device.
Valeritas Holdings, Inc. is a United States-based medical technology company. The Company's product, V-Go Wearable Insulin Delivery device (V-Go), is a wearable, basal-bolus insulin delivery device for adult patients requiring insulin that enables patients to administer a continuous preset basal rate of insulin over 24 hours. V-Go is a small wearable and completely disposable insulin delivery device that a patient adheres to his or her skin every 24 hours. V-Go enables patients to closely mimic the body's normal physiologic pattern of insulin delivery throughout the day and to manage their diabetes with insulin without the need to plan a daily routine around multiple daily injections. It has developed V-Go utilizing its h-Patch platform as a patient-focused solution to address insulin therapies. Its h-Patch platform facilitates the subcutaneous delivery of injectable medicines to patients across a range of therapeutic areas.
VALERITAS HOLDINGS, INC. 
