Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes

Abstract

IntroductionWe compared the efficacy and safety of human regular insulin (HRI) versus rapid-acting insulin (RAI) in a type 2 diabetes population already using the V-Go insulin delivery device.Research design and methodsThis was a 14-week, multicenter, randomized, open-label, parallel-group, phase IV, non-inferiority study. Patients ≥21years of age, with inadequately controlled type 2 diabetes who were currently using the V-Go insulin delivery system with RAI, with glycated hemoglobin (HbA1c) ≥6.5% (≥48 mmol/L) to ≤12.5% (≤108 mmol/L) were randomized 1:1 to RAI continuation or switch to HRI. The primary outcome was estimated treatment difference (ETD) in HbA1c least-squares mean change from baseline at 14 weeks (prespecified non-inferiority hypothesis with 95% CI upper limit <0.4%). Primary analysis was by per protocol (PP); safety analysis was by intention to treat.ResultsWe randomized 136 patients to continued RAI treatment (n=67) or HRI (n=69); 113 patients were included in the PP analysis (RAI, n=54; HRI, n=59). Mean change in HbA1c from baseline to study end was −0.60±1.1% (95% CI −0.90 to –0.29); −6.6±12.0 mmol/mol (95% CI −9.8 to −3.2) with HRI treatment and −0.38±1.3% (95% CI −0.70 to –0.05); −4.2±14.2 mmol/mol (95% CI −7.7 to −0.5) with RAI treatment, with ETD of −0.22% (95% CI −0.67 to 0.22); −2.4 mmol/mol (95% CI −7.3 to 2.4), p=0.007, confirming non-inferiority of HRI to RAI. No between-group differences in changes in total daily insulin doses, number of hypoglycemic values (≤70 mg/dL (≤39 mmol/L) or body weight were observed. No severe hypoglycemic events were reported. Direct pharmacy cost savings (−US$265.85; 95% CI −US$288.60 to −US$243.11; p<0.0001) were observed with HRI treatment.ConclusionsIndividuals with type 2 diabetes requiring insulin can be treated with V-Go wearable insulin delivery device using HRI, safely and effectively, and potentially at a much lower cost compared with RAI, which can lead to improved access to insulin therapy for these individuals.Trial registration numberNCT03495908.

Insulin and insulin analogs as antidiabetic therapy: A perspective from clinical trials

“…When used in an insulin pump, insulins are delivered subcutaneously in microdoses and can be titrated by the hour, a strategy that is typically used in patients with T1D and beyond the scope of this review. In addition, wearable patch-like insulin delivery systems delivering continuous insulin infusion for a period of 24 h have been studied in patients with T2D and may represent an alternative for insulin administration (Mora et al, 2020).…”

Technology in the management of type 2 diabetes: Present status and future prospects

“…Despite concerns regarding the ability of older individuals to manage an insulin pump, it is encouraging that although 38% of participants in the insulin pump therapy group of the OpT2mise trial had cognitive impairment, this did not impact on insulin pump efficacy or safety for these users 84 . Other studies have been carried out in people with T2D to investigate the use of simplified and more affordable insulin pumps with no requirement for pump programming or detailed education sessions, for example the ‘V-Go’ 24-hour disposable patch pump 85 and ‘PAQ’ wearable 3-day CSII device with pre-defined basal insulin and on demand boluses 86 . Significant improvements in HbA1c were noted and patients reported a preference for the simplified CSII device over insulin injections.…”

A Comprehensive Review of the Evolution of Insulin Development and Its Delivery Method

“…ability of patients to use PaQ (patch on insulin delivery device) for the control of blood glucose NCT01535612[158] PaQ Insulin delivery device (Insulin aspart) Type 2 diabetes (Adult) -To evaluate the efficacy and safety of basal bolus insulin delivery with PaQ in insulin NCT02419859[159] iLet bionic pancreas (insulin aspart) Type 1 diabetes (adult) 2To evaluate the safety of insulin aspart in a different insulin delivery setting in the iLet NCT03816761[160] iLet bionic pancreas (BP) (Insulin lispro or aspart)Type 1 diabetes (children, adult) -To compare the insulin-only configuration of the iLet BP system in maintaining normal glycemia compared to usual care in a home-use setting NCT04200313 efficacy of regular human insulin on the V-Go device as compared to rapid-acting insulin in the V-Go device NCT03495908[164] …”