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

George Grunberger, Cheryl R Rosenfeld, Bruce W Bode, Scott D Abbott, Carla Nikkel, Leon Shi, Poul Strange, George Grunberger, Cheryl R Rosenfeld, Bruce W Bode, Scott D Abbott, Carla Nikkel, Leon Shi, Poul Strange

Abstract

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.

Conflict of interest statement

All investigators’ institutions received financial support from Valeritas, Inc. to conduct the clinical trial. G.G. reports that he is a speaker for BI-Lilly, Lilly, Novo Nordisk, and Sanofi. He has also received research grant support from Medtronic and Novo Nordisk. C.R. reports no competing financial interests. B.B. has received speaker and consultant fees from AstraZeneca, BI-Lilly, Janssen, Medtronic, Novo Nordisk, and Sanofi; his employer (Atlanta Diabetes Association) has received research and grant support from Abbott, Dexcom, and Medtronic. S.A. and C.N. are employees of and stockholders in Valeritas, Inc. P.S. has received consultant fees and is a stockholder in Valeritas.com. L.S. reports no competing financial interests.

Figures

Fig. 1
Fig. 1
Comparison of change in HbA1c over time by strata and V-Go use. a Mean HbA1c from screening to month 6; b HbA1c for all patients using V-Go vs. patients discontinuing V-Go; c mean total daily dose from screening to month 6; d total daily dose of all patients using V-Go vs. patients discontinuing V-Go. Stratum 3 (S3) = once/twice-daily long-acting insulin injection ± OADs/non-insulin injectable; stratum 4 (S4) = 1–3 daily premix insulin injections ± OADs/ non-insulin injectable; and stratum 5 (S5) = multiple daily injection (MDI) therapy with 3+ daily insulin injections ± OADs/non-insulin injectable. OADs oral antihyperglycemic drugs
Fig. 2
Fig. 2
Comparison of change in HbA1c from baseline in patients from strata 3, 4, 5 who were using V-Go at month 6 versus patients who discontinued V-Go and resumed other antihyperglycemic therapies for 6 months. Stratum 3 (S3) = once/twice-daily long-acting insulin injection ± OADs/non-insulin injectable; stratum 4 (S4) = 1–3 daily premix insulin injections ± OADs/non-insulin injectable; and stratum 5 (S5) = multiple daily injection (MDI) therapy with 3+ daily insulin injections ± OADs/non-insulin injectable. *For patients who discontinued V-Go, month numbers were grouped into 3-month intervals for the purposes of summarization. OADs oral antihyperglycemic drugs
Fig. 3
Fig. 3
Patient treatment satisfaction ratings for V-Go. Patients (N = 171) answered questions by assigning a value on a scale of 1–10 (with 1 being the worst and 10 being the best) from month 1 of the study to the end of the study. All patient surveys are included, regardless of the completion of the study or the continued use of V-Go

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