Objectives: Severely insulin-resistant type 2 diabetes (T2D) patients face unique treatment challenges. Humulin R U-500 (U-500R) as insulin monotherapy with both basal/bolus properties addresses these challenges but remains understudied. This retrospective study compared real-world patient characteristics, treatment patterns, and outcomes before and after U-500R initiation.

Methods: Adults with T2D on dispensed doses of >180 units/day U-500R monotherapy (index date=first fill) with ≥9-months continuous enrollment both pre- and post-index date and ≥180 units/day insulin pre-index were identified with Veterans’ Health Administration data (01JAN2014-30JAN2017). The overall group was further stratified into elderly, and 201-300 unit dispensed total daily dose (dTDD) subgroups. Syringe and KwikPen users were analysed separately as sub-cohorts. Treatment patterns (dTDD, insulin dosage [units/kg], proportion of days (PDC) covered with insulins, and outcomes (HbA1c, hypoglycemic events) were evaluated descriptively with regression models used to confirm associations between exposure and outcomes.

Results: Among 951 U-500R initiators (overall group), the mean dTDD (248.5 vs 392.1), percentage of patients with insulin dosage >2 units/kg (38.6% vs 88.1%), and mean PDC (73% vs 77%) increased significantly from the pre- to post-index periods (all p<.001). Changes in HbA1c (9.3% vs 8.5%; p<.0001) and hypoglycemia events per patient per year (2.1 vs 3.1, p<.0001) were statistically significant and confirmed by regression models (p-values <.0001). Subgroups (492 elderly, 148 201-300 unit) and device sub-cohorts (714 syringe, 244 KwikPen) showed similar trends.

Conclusions: U-500R initiation was associated with significantly improved treatment compliance patterns and glycemic control, with modest increase in hypoglycemia events.

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