Clinical Evaluation of Basal-Bolus Therapy Delivered by the V-Go® Wearable Insulin Delivery Device in Patients with Type 2 Diabetes: A Retrospective Analysis.

Insulin therapy is frequently required to achieve glycemic targets (A1c) in type 2 diabetes (T2D); however, clinicians and patients face barriers with the complexities of multiple daily injection regimens. Patch-like wearable insulin devices, such as V-Go, may simplify and optimize this complexity. This study evaluated the change in A1C and insulin total daily dose (TDD) in a suboptimally-controlled (not achieving A1C targets) T2D population after switching to V-Go. A retrospective chart analysis at a diabetes clinic was performed to evaluate change in A1c measurements from baseline (V-Go initiation) to end of study observation. Of the 139 patients enrolled, A1C significantly decreased from baseline (-1.5 ± 1.79%; p < 0.001). Patients prescribed insulin at baseline (n = 122) used significantly less insulin TDD (-8 u/day; p = 0.006). The percentage of patients meeting the target of A1C < 8% increased from 14% at baseline to 48% at study completion (p = 0.008). Patients prescribed a basal-bolus regimen prior to V-Go achieved an A1C reduction of 1.5 ± 2.0% (p < 0.0001) and experienced the greatest reduction in TDD (-24 u/day; p < 0.0001). Thus, patients switching to V-Go from a variety of therapies at baseline experienced reductions in A1C while using less insulin, with a reduction in clinically relevant hypoglycemia, indicating the potential benefit of V-Go in optimizing and simplifying T2D care.

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.

INTRODUCTION: We 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 METHODS: This 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. RESULTS: We 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. CONCLUSIONS: Individuals 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 NUMBER: NCT03495908.

Multicenter Real-World Assessment of the Effectiveness of V-Go Wearable Insulin Delivery Device in Adult Patients with Type 2 Diabetes (ENABLE Study): A Retrospective Analysis.

PURPOSE: Patch-like wearable insulin delivery devices are gaining acceptance as a treatment modality for insulin delivery in patients with diabetes. These devices aim to simplify and optimize insulin delivery while reducing barriers associated with a basal-bolus insulin regimen. As clinicians aim to learn more about this method of insulin delivery, real-world evidence can provide insight for patient identification and treatment guidance. This study was performed to evaluate the change in glycemic control (A1C) and insulin total daily dose (TDD) after switching to V-Go wearable insulin delivery device in a type 2 diabetes population with suboptimal control using conventional insulin delivery regimens. PATIENTS AND METHODS: Electronic health records were queried to identify patients meeting inclusion criteria. Study objectives evaluated change in A1C and insulin TDD compared to baseline. A total of 283 patients were enrolled across 9 diabetes specialty sites. RESULTS: A1C significantly decreased from baseline at 3 months (-1.01% ± 0.09; P=0.0001) and 7 months (-1.04% ± 0.10; P<0.0001) after switching to V-Go. TDD of insulin significantly decreased at 3 months (-17 ± 3 U/day; P<0.0001) and 7 months (-14 ± 3 U/day; P<0.0001). Stratifying by prescribed baseline insulin regimen (basal-bolus, basal only or premix) or diabetes duration (<5 years to >20 years) demonstrated significant glycemic improvements from baseline with V-Go regardless of baseline regimen or duration of diabetes. After 7 months of V-Go use, the percent of patients considered high risk (A1C >9.0%) was reduced by nearly half (46% to 24%), and 52% of patients overall achieved an A1C <8%. CONCLUSION: This study represents the largest real-world study of the effectiveness of V-Go in patients with type 2 diabetes. Significant improvements in glycemic control with a reduction in insulin utilization were achieved across varying baseline insulin regimens and regardless of diabetes duration supporting the clinical benefits of this patch-like wearable insulin delivery device.

Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study.

BACKGROUND: V-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. The primary objective was to compare change in mean hemoglobin A1c (HbA1c) from baseline to the end of V-Go use. METHODS: This prospective, open-label, multicenter study recruited patients with type 2 diabetes (T2D) and suboptimal glycemic control (HbA1c ≥ 7%) across 28 centers. Efficacy analyses were conducted for all patients with a post-baseline HbA1c and results stratified based on prior antihyperglycemic medication therapies. Insulin dosing was at the discretion of the health care provider and the protocol did not mandate glycemic targets. Treatment satisfaction surveys were utilized to gain patient feedback on the use of V-Go. RESULTS: One hundred eighty-eight patients were enrolled in the study, among whom 140 patients had a valid post-baseline HbA1c and were included in the primary efficacy analysis. Use of V-Go resulted in a change of - 0.64%; (P = 0.003) in HbA1c from baseline, and in those prescribed insulin, the total daily dose of insulin was decreased by 12 units/day (P < 0.0001). Twenty-two patients (12%) reported hypoglycemic events (≤ 70 mg/dL), with an event rate of 1.51 events/patient/year. CONCLUSION: In a T2D population with suboptimal HbA1c, initiating V-Go therapy in a real-world setting significantly improved glycemic control and led to significant insulin dose reductions. ClinicalTrial.gov registry identifier: NCT01326598.

Clinical and economic considerations based on persistency with a novel insulin delivery device versus conventional insulin delivery in patients with type 2 diabetes: A retrospective analysis.

OBJECTIVE: Insulin is one of the most efficacious treatments for hyperglycemia; however, adherence to insulin therapy is poor, impacting its efficacy. Thus, the objectives of this study were to determine if persistent use of a new insulin delivery option, V-Go, improved clinical outcomes and secondly compare clinical and economic outcomes between persistent use of V-Go and conventional insulin delivery (CID). METHODS: A retrospective review of an outpatient clinic's records was performed. Patients initiating V-Go with documented persistent use of V-Go or resumed persistent use of CID after short-term V-Go use were included (≥5 months of persistency). Baseline data and a total of two post-V-Go or CID initiation visits were examined for clinical and economic outcomes. Cost-effectiveness of each therapy was calculated by dividing the mean cost difference (baseline to office visit 2) by the mean change in A1c (baseline to office visit 2). RESULTS: V-Go persistent patients had a significant decrease in A1c (-1.42; p < 0.001). Between baseline and office visit two, they required less insulin units/day and units/kg and had significantly lower A1c, insulin units/day, insulin units/kg, and 30-day insulin costs than CID patients. V-Go persistent patients had a lower incremental cost by $695.61 per 1% change in A1c compared to CID persistent patients. CONCLUSIONS: Utilization of a new insulin delivery option resulted in improved clinical outcomes compared to CID and was more cost-effective. Clinicians and health plans should consider the use of new insulin delivery options for the management of patients with diabetes on insulin therapy to promote persistence.

Clinical Benefits Over Time Associated with Use of V-Go Wearable Insulin Delivery Device in Adult Patients with Diabetes: A Retrospective Analysis.

INTRODUCTION: Advances in insulin delivery have improved outcomes in patients with diabetes. This study evaluated the impact of V-Go® Wearable Insulin Delivery device on glycated hemoglobin (A1C) and insulin total daily dose (TDD) in patients with diabetes not achieving glycemic targets. METHODS: Electronic medical record data was obtained for adult patients with A1C > 7% treated at a multicenter endocrine practice who initiated V-Go between August 2012 and August 2015. Data were collected at baseline and for up to four follow-up visits, and were analyzed overall, stratified by insulin use at baseline, and for patients prescribed a basal-bolus insulin regimen delivered by multiple daily injections (MDI) at baseline. Economic evaluations were conducted in patients previously prescribed MDI regimens. RESULTS: Patients (N = 103) were evaluated after a mean of 2, 6, 10, and 14 months of V-Go use. Baseline glycemic control was poor (A1C > 9%) in 59% of patients. Significant, sustained reductions in A1C compared with baseline were observed at every visit (p < 0.0001), with mean ± SE decrease of 1.67 ± 0.24% after 14 months. For patients prescribed insulin at baseline (n = 80), TDD was significantly reduced at all visits (p < 0.0001), with mean ± SE reduction of 17 ± 4.5 units/day at 14 months. Patients previously prescribed MDI therapy (n = 58) benefited from 1.53 ± 0.31% (p < 0.001) A1C reduction and TDD decrease of 30 ± 5 units/day after 14 months. Direct pharmacy wholesale acquisition costs for diabetes therapeutics were reduced by $25.00/patient/month. CONCLUSION: Use of V-Go was associated with improved glycemic control and decreased TDD. For patients previously prescribed basal-bolus MDI therapy, switching to insulin therapy with V-Go resulted in pharmacy cost savings based on wholesale acquisition costs. V-Go offers an efficacious method of insulin delivery that improves outcomes in patients and can reduce costs. FUNDING: Valeritas, Inc.

The Clinical and Economic Impact of the V-Go® Disposable Insulin Delivery Device for Insulin Delivery in Patients with Poorly Controlled Diabetes at High Risk.

BACKGROUND: Diabetes is a chronic condition and when poorly controlled can lead to complications and death. Patients with glycated hemoglobin (A1C) measures >9 % are at significant risk for diabetes-related complications impacting the patient's quality of life and imposing higher costs on the healthcare system. A1C reductions of 1 % or greater in this population have demonstrated substantial health and economic benefits. Reducing the percent of patients at risk is an essential component of quality-care measures established for patients with diabetes. OBJECTIVE: To evaluate if switching patients prescribed subcutaneous insulin injections to V-Go for insulin delivery would impact clinical and economic parameters in patients with poorly controlled diabetes (A1C > 9 %). METHODS: The study was a retrospective analysis using data extracted from the electronic medical records database of a multicenter diabetes system. Outcome measures included mean change in A1C from baseline, the percent of patients achieving a reduction in A1C ≥1 % while on V-Go therapy, and the impact to quality measures. In addition, economic analyses were conducted to assess the pharmacy budget impact and projected implication to total healthcare cost. RESULTS: Ninety-seven patients were evaluated after a mean duration of 13.6 ± 6.9 weeks of insulin delivery with V-Go. Switching to V-Go resulted in an overall mean change (95 % CI) in A1C of -2.0 % (-1.7 to -2.3; p < 0.001) from a baseline of 10.5 %. Seventy-three percent of patients achieved an A1C reduction ≥1 %. Cost analysis supported a direct pharmacy savings of $119.30 (18.80-219.60, p = 0.020) per patient per month compared with baseline. CONCLUSION: Switching to V-Go for insulin delivery resulted in significant glycemic improvement and proved cost effective. This real-world assessment could be applied more broadly at the health system and plan level.

CLINICAL AND COST-EFFECTIVENESS OF INSULIN DELIVERY WITH V-GO(®) DISPOSABLE INSULIN DELIVERY DEVICE VERSUS MULTIPLE DAILY INJECTIONS IN PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON BASAL INSULIN.

OBJECTIVE: To compare two methods of delivering intensified insulin therapy (IIT) in patients with type 2 diabetes inadequately controlled on basal insulin ± concomitant antihyperglycemic agents in a real-world clinical setting. METHODS: Data for this retrospective study were obtained using electronic medical records from a large multicenter diabetes system. Records were queried to identify patients transitioned to V-Go(®) disposable insulin delivery device (V-Go) or multiple daily injections (MDI) using an insulin pen to add prandial insulin when A1C was >7% on basal insulin therapy. The primary endpoint was the difference in A1C change using follow-up A1C results. RESULTS: A total of 116 patients were evaluated (56 V-Go, 60 MDI). Both groups experienced significant glycemic improvement from similar mean baselines. By 27 weeks, A1C least squares mean change from baseline was -1.98% (-21.6 mmol/mol) with V-Go and -1.34% (-14.6 mmol/mol) with MDI, for a treatment difference of -0.64% (-7.0 mmol/mol; P = .020). Patients using V-Go administered less mean ± SD insulin compared to patients using MDI, 56 ± 17 units/day versus 78 ± 40 units/day (P<.001), respectively. Diabetes-related direct pharmacy costs were lower with V-Go, and the cost inferential from baseline per 1% reduction in A1C was significantly less with V-Go ($118.84 ± $158.55 per patient/month compared to $217.16 ± $251.66 per patient/month with MDI; P = .013). CONCLUSION: Progression to IIT resulted in significant glycemic improvement. Insulin delivery with V-Go was associated with a greater reduction in A1C, required less insulin, and proved more cost-effective than administering IIT with MDI. ABBREVIATIONS: A1C = glycated hemoglobin ANCOVA = analysis of covariance CI = confidence interval CSII = continuous subcutaneous insulin infusion FPG = fasting plasma glucose IIT = intensified insulin therapy LSM = least squares mean MDI = multiple daily injections T2DM = type 2 diabetes mellitus TDD = total daily dose.

Use of V-Go® Insulin Delivery Device in Patients with Sub-optimally Controlled Diabetes Mellitus: A Retrospective Analysis from a Large Specialized Diabetes System.

INTRODUCTION: Tight glycemic control and timely treatment can improve outcomes in patients with diabetes yet many remain sub-optimally controlled. The objective of the current study was to evaluate the effect of switching patients with sub-optimally controlled diabetes to the V-Go® (Valeritas Inc., Bridgewater, NJ, USA) Disposable Insulin Delivery device. METHODS: A retrospective analysis of electronic medical records was conducted to assess patients with sub-optimal glycemic control defined as a glycated hemoglobin (HbA1c) >7%, switched to V-Go. Blood glucose control defined as change from baseline in HbA1c, prescribed insulin doses, body weight, concomitant anti-hyperglycemic agents, and reported hypoglycemia were collected prior to switching to V-Go and during V-Go use. RESULTS: Two-hundred and four patients were evaluated during the study period. Overall, there was a significant decrease in HbA1c after switching to V-Go at the 14- and 27-week follow-up visits. The least-squares mean (LSM) change in HbA1c (95% confidence interval) from baseline to 14 weeks was -1.53% (-1.69% to -1.37%; P < 0.001), and from baseline to 27 weeks was -1.79% (-1.97% to -1.61%; P < 0.001). Significant reductions in mean HbA1c were achieved at both visits in all patient subsets: Patients with type 2 and type 1/latent autoimmune diabetes in adults (LADA); patients using insulin at baseline and patients naïve to insulin at baseline. Patients administering insulin at baseline required significantly less insulin on V-Go (86-99 LSM units/day at baseline to 58 LSM units/day at 27 weeks; P < 0.001). Across all patients, reported hypoglycemic events were no more frequent on V-Go than on previous therapy. CONCLUSION: V-Go is safe and effective in patients with sub-optimally controlled diabetes requiring insulin therapy. Glycemic control improved significantly, less insulin was required, and hypoglycemic events were similar after patients switched to insulin delivery by V-Go. FUNDING: Valeritas, Inc.

Exenatide once weekly: opportunities in the primary care setting.

Type 2 diabetes mellitus is a pandemic, with millions of new diagnoses made each year. In the United States, > 90% of patients with type 2 diabetes mellitus are cared for by primary care physicians who bear the primary responsibility of diagnosing and treating this disease. Building an optimal treatment regimen for a patient from the many choices available depends on many factors, including the ability of a given therapy to safely and effectively lower blood glucose levels, and potential benefits on body weight, cardiovascular risk factors, and hypoglycemia risk. With these considerations at the forefront, this article provides an overview of exenatide once weekly (EQW), a recently available antidiabetes therapy in the glucagon-like peptide-1 receptor agonist class designed to provide continuous glycemic control with once-weekly dosing. We discuss the clinical trials that have demonstrated the ability of EQW to effectively lower blood glucose levels and body weight with a minimal risk of hypoglycemia. In addition, we examine other issues likely to be relevant in a primary care setting, including safety and tolerability profiles, pharmacology and dosing, ease of use, recommended place in treatment, and patient perceptions of EQW.