Journal
DRUGS-REAL WORLD OUTCOMES
Volume 7, Issue 1, Pages 31-40Publisher
SPRINGERNATURE
DOI: 10.1007/s40801-019-00173-8
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- Valeritas Inc, Bridgewater, NJ, USA
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BackgroundV-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.MethodsThis 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.ResultsOne 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.ConclusionIn 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.
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