Insulin glargine-300 (U-300) provides a flatter and more prolonged profile than U-100, with less risk of hypoglycemia. Real-world evidence of the effect of U-300 on Patient Reported Outcomes (PROs) is lacking. Adults with type 2 diabetes (T2DM) using insulin for ≥6 months and initiating U-300 were included. Data were collected at baseline (start U-300; T0)), 3 (T1) and 6 months (T2). Intention-to-treat mixed model analyses examined change over time in HbA1c, self-reported hypoglycemia and PROs: emotional well-being (WHO-5), hypoglycemia worries (HFS-W), diabetes distress (PAID-SF), diabetes medication convenience (DMSRQ), sleep quality and duration (PSQI), and adherence (1 item SDSCA). Also, the extent to which U-300 fulfilled its expectations was measured at T2 both in physicians and patients. P-value threshold was set at .for the WHO-5 and .01 for other outcomes.In total,162 persons with T2DM participated: 53.7% men, mean age 64.54 years (9.05), baseline mean HbA1c 62.48 mmol/mol (12.61). Hypoglycemia incidence decreased non-significantly: for symptomatic events from 31.5% (T0) to 24.8% (T2), nocturnal events from 6.8% (T0) to 4.1% (T2), severe events from 4.9% (T0) to 0.0% (T2). HbA1c trended towards a decrease to 60.32 mmol/mol (12.09) (T2). Mean WHO-5 scores trended towards improvement, from 61.73 (T0) to 63.93 (T2). Mean DMSRQ scores improved significantly from 32.70 (T0) to 35.80 (T1) (beta T0-T1 = 3.28; p<.001; 95% CI = 1.67 to 4.89) and 36.96 (T2) (beta T0-T2 = 4.40; p<.001; 95% CI = 2.77 to 6.02). U-300 fulfilled (or exceeded) its expectations in 89,0% of physicians and 92.4% of patients. Other PROs did not change significantly over time. U-300 fulfills physicians’ and patients’ expectations and improves diabetes medication convenience, possibly due to more flexible injection timing. Future research should further explore effects on quality of life in a more diverse population.


T.H. Wieringa: Other Relationship; Self; Sanofi. M. de Wit: Advisory Panel; Self; Sanofi.J. Twisk: None.F.J. Snoek: None.

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