Zealand Pharma presents positive clinical and health economic outcome data with use of regular human insulin delivered by the V-Go in adults with type 2 diabetes.

Zealand Pharma A/S , announces clinical non-inferiority and positive health economic outcomes with use of regular human insulin (RHI) versus rapid acting insulin (RAI) when delivered by V-Go. Clinical outcomes of the trial are highlighted in a press release issued by Endocrine Society and the full abstract will be published in a supplemental issue of the Journal of the Endocrine Society. Health economic outcomes will be published online in April in the Journal of Managed Care & Specialty Pharmacy supplement.

This 14-week randomized, non-inferiority trial was conducted in a real-world practice setting under usual standard of care across three centers in the United States. Patients administering U-100 RAI analogs with V-Go were randomly assigned to either continue RAI delivery by V-Go or switch to U-100 RHI. The primary end-point was change in overall blood glucose levels (HbA1c), assessments of safety measures and insulin costs were evaluated as secondary endpoints.

Results of the trial demonstrate non-inferiority for change in HbA1c between RHI and RAI (-0.60% for RHI vs -0.38% for RAI with an estimated treatment difference (ETD) of -0.22%; 95% confidence interval: -0.67% to 0.22%; non-inferiority margin <0.4% and p=0.007). From a baseline 30-day insulin cost of $515.68 for patients switched to RHI and $518.31 for patients continuing RAI, the 30-day change in insulin cost at study end was -$250.50 for RHI and +$15.35 for RAI (ETD: -$265.85; p<0.0001). The mean change in total daily dose of insulin with RHI was 0.8 U/day from a baseline of 61.0 U/day vs 1.8 U/day from a baseline of 61.3 U/day with RAI (ETD: -1.04 U/day; p=0.34).

No significant difference for patient-reported hypoglycemia were observed by the end of the study. No intervention-related moderate or severe adverse events were reported in either group. One mild event (upset stomach) possibly related to the intervention was reported in the RHI group and two mild events (skin irritation and skin welt) in the RAI group.

“Delivery of a lower-cost regular human insulin by V-Go, when compared to analog insulin, resulted in similar efficacy for controlling blood sugar at a significant cost savings,” said Pablo Mora, MD, FACE, CDCES, from the Dallas Diabetes Research Center, Coordinating Investigator for the study. “Expanding the affordability of insulin therapies can have positive implications on insulin adherence and lead to improved clinical outcomes for patients struggling to afford insulin therapy.”