First US Pragmatic Clinical Trial Results for Diabetes Device Presented at ADA Demonstrate Real-World Clinical and Economic Benefits

Wilmington, Del.—June 12, 2017 — Valeritas Holdings, Inc., and HealthCore, Inc., the outcomes research subsidiary of Anthem, Inc., completed the first U.S. diabetes device pragmatic clinical trial, marking the beginning of a novel approach to translational research on how different methods of insulin delivery work in a real-world environment. A podium presentation of the study took place at the American Diabetes Association 77th Scientific Session annual meeting.

HealthCore and Valeritas studied the real-world effectiveness of the V-Go® Wearable Insulin Delivery device compared to standard treatment in adults with type 2 diabetes in the United States in community-based practices using routine clinical care without forced or mandated protocols. All medications and supplies were purchased by patients using their pharmacy benefit and standard co-pays.

V-Go Wearable Insulin Delivery device, is a simple, wearable, basal-bolus insulin delivery device for patients with type 2 diabetes that enables patients to administer a continuous preset basal rate of insulin over 24 hours and on-demand bolus dosing at meal-times.

“There are nearly 6 million Americans living with type 2 diabetes who are prescribed insulin and a large percentage of these patients are unable able to effectively manage their A1C using multiple daily injections,” said John Timberlake, Valeritas president and chief executive officer. “The results from this study show real-world meaningful clinical and economic benefits by changing the way that insulin is administered. Patients using V-Go® to deliver insulin showed a significant reduction in both A1C and the amount of insulin being used compared to patients using standard insulin injections who may have difficulty taking three or four injections each day.”

This study was a pragmatic clinical trial evaluating V-Go compared to a standard treatment optimization control. The trial utilized cluster randomization where study sites were randomized to V-Go or optimizing standard of care based on individual physician preference. Patients with type 2 diabetes taking insulin were enrolled and treated according to routine practice for up to four months. Patients initializing V-Go stopped other insulin therapy.

The primary outcome was the difference in the change in A1C from baseline to end of study. The study demonstrated that while V-Go patients had significantly higher A1Cs at baseline compared to patients continuing and optimizing standard of care diabetes regimens, their A1C dropped significantly more over time compared to standard treatment optimization. Patients on V-Go received fewer concomitant diabetes medications and V-Go was more cost-effective.

“We know that insulin is effective when patients take it as prescribed,” said Mark Cziraky, PharmD, HealthCore vice president for research. “The key is to see through these progressive trials to see if one treatment approach is more effective than another in routine clinical practice settings. The best way to assess this is through implementing a pragmatic clinical trial design.”

The analysis population included 415 patients, 246 STO and 169 V-Go across 52 sites. As a pragmatic clinical trial, the population was largely similar to the general diabetes population receiving insulin with higher baseline A1Cs and comorbidities compared to traditional exploratory clinical studies.

About HealthCore Inc.

HealthCore Inc.,, uses real world data, including claims information, to provide clinical and other scientific expertise and research services to the pharmaceutical, biotechnology and device industries, in the conduct of industry-sponsored safety, health economic outcomes, comparative effectiveness, epidemiological and late stage research projects. HealthCore’s capabilities include retrospective database design and analysis, prospective observational research design and analysis, safety and epidemiologic research services, post authorization safety study (PASS), health services research, patient and/or provider survey development and implementation, and general research consultation.