IDF21-0140 Higher derived time in range with insulin degludec/insulin aspart vs insulin glargine U100 in Japanese adults with T2D

Background: Time in range (TIR) is an important metric providing reliable information on overall glycaemic control and a convenient method to differentiate between insulin therapies. Aim: We used the concept of blood-glucose monitored derived TIR (dTIR) to evaluate and compare treatment with insulin degludec/insulin aspart (IDegAsp) and insulin glargine 100 units/mL (IGlar U100) in insulin-naïve patients with type 2 diabetes (T2D). Method: Data from BOOST Japan – a phase 3, open-label, treat-to-target trial of insulin-naïve Japanese adults with T2D who were randomised to either IDegAsp (n=147) or IGlar U100 (n=149) – were evaluated post hoc. Self-monitored blood glucose profiles (weeks 0, 12, 16 and 26) were used to derive the proportion of available readings within (dTIR: 3.9–10 mmol/L [70–180 mg/dL]), below (derived time below range [dTBR]: <3.9 mmol/L [<70 mg/dL]), or above (derived time above range [dTAR]: >10 mmol/L [>180 mg/dL]) target range. Profiles with ≥6 non-missing points from the 9-point profiles for patient visits were included. The change from baseline to end of treatment (EOT; Week 26) was calculated for patients with assessments at both visits; estimated treatment differences (ETDs; IDegAsp−IGlar U100) were analysed by ANCOVA. Results: The change from baseline to EOT in dTIR was significantly greater with IDegAsp versus IGlar U100 (ETD [95% CI]: 5.28% [1.21; 9.35], p=0.0112). The ETD [95% CI] for dTBR was -0.12% [-1.54; 1.30], p=0.8678; the ETD [95% CI] for dTAR [95% CI] was -5.13% [-9.08; -1.17], p=0.0113. The proportion of patients achieving ≥70% dTIR at EOT with IDegAsp and IGlar U100, respectively, was 50.3% and 34.2%; the proportion achieving a ≥5% increase in dTIR from baseline to EOT was 71.4% and 59.7%, respectively; and the proportion achieving ≥70% dTIR without dTBR from baseline to EOT was 42.9% and 30.9%, respectively. Discussion: IDegAsp was associated with significantly greater dTIR versus IGlar U100 without an increase in dTBR in insulin-naïve patients with T2D, highlighting the clinical value of IDegAsp – a unique co-formulation that provides convenient dosing with the main meal.