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Diabetes on the Go with V-Go®

By Lourdes Cross posted 07-27-2020 15:10

  

Diabetes on the Go with V-Go®

Elizabeth Klejna, WNEU COPHS PharmD candidate 2020

Caitlyn Efendioglu, WNEU COPHS PharmD candidate 2020

 

In 2012, Valeritas, Inc. introduced V-Go®, a daily patch-like insulin delivery system that continuously delivers insulin throughout the day for people aged 21 years or older. Since being brought to market, Valeritas, Inc. was acquired by Zealand Pharma, a Copenhagen-based biotechnology company.1 V-Go® is not an insulin pump but rather an insulin delivery system. It provides insulin in two ways, similar to how the body provides insulin: it provides a steady rate of basal insulin and provides additional bolus insulin at mealtimes by clicking a button.2 V-Go® is available in three options: V-Go® 20 which delivers a basal rate of 20 units/24 hours, V-Go® 30 which delivers a basal rate of 30 units/24 hours, and V-Go® 40 which delivers a basal rate of 40 units/24 hours. All three options allow up to 36 units of bolus insulin dosing in 2-unit increments (1 push = 2 units). Of note, the bolus delivery button can only be pushed 18 times in every 24 hour period.2 Valeritas, Inc., has tested Humalog® (insulin lispro, rDNA origin) and Novolog®(insulin aspart, rDNA origin) and found them to be safe for use in V-Go®.3 Instructions on how to use the V-Go® are available from the manufacturer at the link found at the end of the post.

 

Each V-Go® is intended to be worn for one 24-hour period. It can be worn any place that insulin can be injected or infused into subcutaneous tissue, such as the abdomen or backside of the arm. The location of the V-Go® should be shifted every 24 hours and be at least 1 inch away from the previous site.2 Each V-Go® kit contains 30 single-use V-Go® devices and one EZ Fill filling accessory.3 When starting on V-Go®, two prescriptions are required: one for the device and one for insulin.3

 

V-Go® minimizes the amount of total daily insulin injections and improves A1C.  In a poster presentation at the 2017 American Association of Clinical Endocrinologists Annual Meeting, Harrison HC et al. reported that 88 people with type 2 diabetes on > 2 injections/day at baseline who were switched to V-Go® had an average decrease in A1C of 1.3% (from a baseline A1C of 9.5%) after 15 weeks.4 Additionally, the patients experienced a significant reduction in total daily dose (TDD) of insulin after being switched to V-Go® from a mean of 72 units/day at baseline to a mean of 60 units/day 15 weeks after switching.4 The study population was identified by a retrospective search of patients at a multi-center endocrinology site for those who had been switched from multiple daily insulin injections to V-Go®. The average age was 60 years old (± 11 years) and average duration of diabetes was 15 years (± 7 years).4

 

While V-Go® is marketed for use with rapid-acting insulin (RAI), increasing prices of RAI has led to patients rationing their insulin or total discontinuance of therapy.5 In response to this, a study by Pablo Mora, et al. set out to evaluate the use of different insulin types via V-Go® in adults with type 2 diabetes mellitus (T2DM) requiring insulin therapy.6 The purpose of the study was to compare the efficacy and safety of U-100 RAI versus U-100 regular human insulin (RHI) when delivered by V-Go®.6 Eligible subjects were randomized to either stay on RAI delivered by V-Go® or randomized to switch to U-100 RHI delivered by V-Go®.6 The primary outcome was the change in A1C after 12 weeks of treatment.

 

The results were published in an abstract for the Endocrine Society’s Annual Meeting (ENDO 2020).7 One hundred and thirteen patients were evaluated (54 in the RAI group versus 59 in the RHI group). The inclusion criteria were >21 years of age with T2DM and an A1C > 7% and < 12.5%. As indicated by the results below, the study met its primary endpoint of non-inferiority and researchers found no between-group differences in the total daily dose (TDD) of insulin requirements. Additionally, RHI resulted in a slightly greater decrease in mean A1C and there was no between-group difference in episodes of hypoglycemia.

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Cost remains a significant barrier to insulin use in people with diabetes. Cash price ranges from $300-$400. It may be covered by insurance and there are co-pay assistance cards available from the manufacturer. As of now, only RAI has been approved by the FDA for use with V-Go®. With that being said, there is data available that demonstrates the use of RHI delivered via V-Go® can provide similar glycemic control and hypoglycemia event rate compared to use with RAI.
Screen_Shot_2020-07-27_at_3_07_40_PM.pngInstructions for use: http://www.go-vgo.com/wp-content/uploads/2018/06/instructions-for-patient-use.pdf


References

  1. Zealand Pharma completes the acquisition of Valeritas [Internet]. GlobeNewswire, Inc.; 2020 Apr 02 [cited 2020 Apr 24]. Available from: https://www.globenewswire.com/news-release/2020/04/02/2010773/0/en/Zealand-Pharma-completes-the-acquisition-of-Valeritas.html
  2. What is V-Go? [Internet]. Boston (MA): Zealand Pharma U.S., Inc.; 2020 [cited 2020 Apr 21]. Available from: https://www.go-vgo.com/how-v-go-works/what-is-v-go/
  3. Helpful pharmacy information for V-Go. [Internet]. Boston (MA): Zealand Pharma U.S., Inc.; 2020 [cited 2020 Apr 21]. Available from: https://www.go-vgo.com/hcp/pharmacists/overview/
  4. Harrison HC, Everitt B, Nikkel C. The Impact of utilizing a novel insulin delivery device in patients with type 2 diabetes poster presentation at American Association of Clinical Endocrinologists; May 2017; Austin, TX.
  5. Wearable delivery device allows patients with type 2 diabetes to safely use more affordable insulin option [Internet]. Washington, DC: Endocrine Society; 2020 Mar 31 [cited 2020 Apr 21]. Available from: https://www.endocrine.org/news-and-advocacy/news-room/2020/wearable-delivery-device-allows-patients-with-type-2-diabetes
  6. Mora P, Sutton DR, Gore A, et al. OR30-02: Efficacy and safety comparison between U100 regular human insulin and U100 rapid acting insulin when delivered by a 24 hour wearable insulin delivery device in type 2 diabetes. 2018 Apr 12 [last updated 2019 Aug 16; cited 2020 Apr 21]. In: ClinicalTrials.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine. 2000. Available from: https://clinicaltrials.gov/ct2/show/study/NCT03495908.
  7. Mora P, Sutton DR, Gore A, et al. Efficacy and safety comparison between U100 regular human insulin and U100 rapid acting insulin when delivered by a 24 hour wearable insulin delivery device in type 2 diabetes [abstract]. Endocrine Society’s Annual Meeting, San Francisco (CA). 2020 Mar 28-31.

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