Introduction: U-500 regular insulin (U-500R) was developed to help severely insulin-resistant patients meet high insulin requirements (>200 units/day). Here, we described in real-world setting a patient cohort using ≤200 units/day of standard concentration insulin or non-U500R concentrated insulin per pharmacy claims, who were then transitioned to U-500R with an average total daily dose (TDD) of >200 units/day.
Methods: Adults with ≥2 T2D claims who initiated U-500R (index) and had ≥1 HbA1c value in both 9-month pre- and 9-month post-index periods in the Veterans Health Administration database (01JAN2014-30JUN2017) were included. Treatment patterns and outcomes (observed TDDs for index claim, observed TDD, HbA1c, and hypoglycemia events per patient per year (PPPY) in pre and post-index periods) were assessed in both periods. Paired t-test or McNemar’s test was used for descriptives. Mixed linear model (MLM) and zero-inflated negative-binomial mixed model (ZINBM) were used to confirm the effect of U-500R exposure on HbA1c and hypoglycemia, respectively, adjusting for demographics, BMI, comorbidity index and TDD.
Results: Of 1,191 U-500R initiators, mean age was 63 years with 82% white, 96% male, and a mean BMI of 40. TDD for index U-500R claim was 354 units. Mean TDDs (147 units vs. 346 units), HbA1c (9.6% vs. 8.6%), and hypoglycemia (2.0 vs. 3.3) differ significantly pre- and post-index (p≤0.05), respectively. MLM confirmed HbA1c significantly dropped by 0.8% (p<0.01). ZINBM showed a 0.5 PPPY increase in hypoglycemia post-index (p<0.01).
Conclusions: Using insulin claims data, U-500R initiation resulted in a significant TDD increase of 199 units, which was accompanied by a significant drop in HbA1c and a slight increase in hypoglycemia. The low TDD and poor glucose control prior to U-500R initiation indicated poor patient compliance to the prescribers’ dosing intentions.
R.C. Hood: Advisory Panel; Self; Eli Lilly and Company, Insulet Corporation. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc. L. Fan: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. R.D. Pollom: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. S. Borra: Employee; Self; STATinMED. Other Relationship; Self; Eli Lilly and Company. A. Huang: Employee; Self; STATinMED. Other Relationship; Self; Eli Lilly and Company. J. Chen: None.
