Clinical Trial Evaluating Valeritas’ V-Go Meets Primary A1c Endpoint

Valeritas Holdings Inc., a medical technology company and maker of V-Go Wearable Insulin Delivery device, an all-in-one, wearable insulin delivery option for patients with diabetes, 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 percent 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 in August to end the study early.
 
“We are very pleased that the interim analysis clearly demonstrated non-inferiority between U-100 Rapid Acting Insulin and Regular Human Insulin when delivered by V-Go and believe the results from this study could have a meaningful impact for the many patients who have difficulty affording their insulin,” said Pablo Mora, M.D., FACE, CDE, from the Dallas Diabetes Research Center, coordinating investigator for the study. “Insulin therapy is necessary for many patients to control diabetes, and the potential to enable use of a lower-cost yet effective option like Regular Human Insulin can benefit patient adherence resulting in improved blood sugar control.”

The study is an investigator-initiated multi-center prospective, randomized, parallel, non-inferiority 14-week trial comparing the efficacy and safety of U-100 Regular Human Insulin to U-100 Rapid Acting Insulin analog in a type 2 diabetes population already using V-Go Wearable Insulin Delivery device filled with Rapid Acting Insulin. The study is managed and executed by East Coast Institute for Research (ECIR) with enrollment conducted at Northeast Florida Endocrine and Diabetes Associates in Jacksonville, Fla., by Principal Investigator David Sutton, M.D., FACE, and The Jones Center for Diabetes and Endocrine Wellness in Macon, Ga., by Principal Investigator Ashwini Gore, M.D., and in Columbus, Ga., by Bantwal Baliga, M.D.
 
“The investigators in this multi-center study have done profoundly important work by demonstrating that V-Go delivery devices utilizing less expensive U-100 Regular Human Insulin were just as effective as V-Go devices utilizing U-100 Rapid Acting Insulin. Use of Regular Human Insulin could save U.S. patients with type 2 diabetes and healthcare systems thousands of dollars per patient annually,” said John Timberlake, president and CEO of Valeritas.
 
At this time the use of U-100 Regular Human Insulin with V-Go Wearable Insulin Delivery device has not been cleared by the U.S. 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.
 
The East Coast Institute for Research is dedicated to developing new research. Its research involves the latest medications and devices not yet available to the general public and is conducted at its facilities in northeast Florida and Georgia and has affiliations with several physician practices in the area. Their capabilities encompass Phase II, III and IV clinical trials, including both sponsor and investigator initiated studies of drugs and devices.
 
Valeritas is a commercial-stage medical technology company focused on improving health and simplifying life for people with diabetes by developing and commercializing technologies. Valeritas’ flagship product, V-Go Wearable Insulin Delivery device, is an all-in-one basal-bolus insulin delivery option for patients with type 2 diabetes that is worn like a patch and can eliminate the need for taking multiple daily shots. V-Go administers a continuous preset basal rate of insulin over 24 hours, and it 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, N.J., Valeritas operates its R&D functions in Marlborough, Mass.
 
Humalog is a registered trademark of Eli Lilly and Company and NovoLog is a registered trademark of Novo Nordisk A/S.