EFFICACY AND SAFETY COMPARISON BETWEEN U-100 REGULAR HUMAN INSULIN AND RAPID ACTING INSULIN WHEN DELIVERED BY V-GO WEARABLE INSULIN DELIVERY DEVICE IN TYPE 2 DIABETES
- Pablo Mora, United States of America
- Pablo Mora, United States of America
- David R. Sutton, jr., United States of America
- Ashwini Gore, United States of America
- Bantwal S. Baliga, United States of America
- Rebecca F. Goldfaden, United States of America
- Carla Nikkel, United States of America
- John Sink ii, United States of America
- Beverley Adams-huet, United States of America
Abstract
Background and Aims
Increasing insulin prices have led to a renewed debate to determine if Rapid Acting Insulin (RAI) analogs offer an advantage over less expensive Regular Human Insulins (RHI). Meta-analyses have shown RAI analogs offer no advantage over RHI; however, to our knowledge, no data exists when delivered via continuous subcutaneous infusion. V-Go® is a 24-hr wearable patch-like insulin delivery device providing a preset continuous basal rate of insulin and on-demand bolus dosing. This study compared the efficacy and safety of RAI versus RHI when delivered by V-Go.
Methods
This multi-center prospective, randomized, parallel, non-inferiority 14-week study was conducted in a T2DM population in the United States. Patients administering RAI with V-Go were randomized to continue RAI or switch to RHI. Primary endpoint assessed non-inferiority for the between group net difference in A1C derived from a mixed model analysis; non-inferiority margin=0.4%. Between group differences from baseline for hypoglycemia (based on three 7point glucose profiles), insulin total daily dose (TDD) and weight were evaluated as secondary endpoints.
Results
One hundred thirteen patients (59 RHI and 54 RAI) were evaluated. Baseline characteristics were similar between cohorts. Change in A1C favored RHI and non-inferiority to RAI was demonstrated. Absolute change in the % of patients with documented hypoglycemia from pre-randomization to the end of study was not statistically different between groups (RHI +5.1% vs RAI +5.6%). Between group differences for TDD and weight were not statistically different.
Conclusions
Patients administering RAI with V-Go can safely switch to RHI delivery with V-Go and maintain similar glycemic control.