Valeritas says trial on insulin delivered by V-Go meets primary A1c endpoint
Valeritas Holdings announced that a randomized controlled trial comparing the delivery of U-100 Regular Human Insulin by V-Go versus delivery of Rapid Acting Insulin by V-Go in patients with type 2 diabetes has met the primary A1c endpoint. A planned interim analysis was reviewed by an independent Data Safety and Monitoring Committee 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 and NovoLog have been tested by Valeritas, Inc. and found to be safe for use in the V-Go Wearable Insulin Delivery device.