Introduction: Human regular U-500 insulin (U-500R) improves glycemic control in people with type 2 diabetes (PwT2D) inadequately controlled with high doses of other insulins. Limited evidence exists on treatment patterns and outcomes in PwT2D who initiate U-500R using a U-500R KwikPen (U500KP) in the real-world setting.

Methods: Adults with ≥2 claims for T2D and initiating U500KP (index date: 1st claim) in Veterans Health Administration data (01MAR2016-01JUN2017) were identified. Inclusion criteria included continuous enrollment and ≥1 A1C measure in 9 months of both pre- and post-index date and no U-500R use in 9 months pre-index. Treatment patterns and outcomes including observed total daily dose (TDD), A1C level, and hypoglycemia events (ICD-9 diagnosis codes, glucagon administration, blood glucose ≤70 mg/dl) per patient per year (PPPY) in 9 months pre- and post-index were compared using paired t-test and McNemar’s test. Linear Mixed Model (LMM) was used to confirm the effect of U500KP initiation on A1C, adjusting for demographics, Quan-Charlson Comorbidity Index (Q-CCI) and TDD.

Results: PwT2D who initiated U500KP were identified (n=647). Mean age was 64 years, most were white (80%) and men (97%). Mean Q-CCI score was 3.8. After initiating U500KP, mean TDD increased from 188 to 270 units. 62% of the PwT2D had a TDD ≤200 units in the pre-index period, with 27% remaining on ≤200 units post-index. After U-500R initiation, mean A1C decreased from 9.5% to 8.7% (p<0.0001). LMM confirmed this A1C decrease was significant. Hypoglycemic events PPPY increased from 4.3 to 5.3 (p<0.05).

Conclusions: Post-U500KP initiation, there is a clinically significant drop in A1C accompanied by an average increase of 1 hypoglycemic event/year. Analysis showed that most PwT2D requiring high dose insulin starting U500KP were on TDD ≤200 units pre-index. After initiation of U500KP, TDD increased by ∼80 units with 1 in 4 PwT2D continuing on TDD ≤200 units.


J. Chen: Employee; Self; Eli Lilly and Company. L. Fan: Employee; Self; Lilly Diabetes. Stock/Shareholder; Self; Lilly Diabetes. R. Juneja: Employee; Self; Eli Lilly and Company. S. Borra: Other Relationship; Self; STATinMED. A. Huang: Other Relationship; Self; STATinMED. L. Wang: Other Relationship; Self; STATinMED.

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