Abstract 28: Change in glycaemic parameters in adults with type 2 diabetes initiated with or switched to insulin degludec/insulin aspart (IDegAsp) in a real-world setting – An analysis of Indian cohort of ARISE study

Aim: To investigate the effect of insulin degludec/insulin aspart (IDegAsp) on glycaemic control in people with T2DM treated with IDegAsp in real-world setting. Methods: This was a ~26 weeks open-label, non-interventional study (NCT04042441) including 1102 T2DM adults on any anti-hyperglycaemic treatment initiating or switching to IDegAsp as per local practice in 6 countries. Participants were included based on physician's decision to start treatment with IDegAsp. Primary endpoint was change in glycosylated haemoglobin (HbA1c) from baseline to end of study (EOS). Results: Amongst 185 participants from India, 57.3% (n=106) were men. The mean age was 58.1±10.3 years, with the mean duration of T2DM being 14.4±8.1 years. IDegAsp was given once daily (n = 81 [43.8%]) or twice daily (n=104 [56.2%]) ± OADs. Of these, initiation was done in 90 (48.6%) participants uncontrolled on OADs. Mean HbA1c (SD) decreased significantly from 9.8 (1.8)% at baseline to 8.2 (0.1)% at the EOS; change in HbA1c from baseline [95% CI]: -1.6% [-1.83; -1.42], p<0.0001. There was significant reduction in mean fasting plasma glucose, FPG (SD) from 190.0 (65.8) mg/dl at baseline to 141.9 (4.3) mg/dl at EOS; change in FPG from baseline [95% CI]: -52.2 mg/dl [-60.65; -43.66], p<0.0001. Mean body weight (SD) changed from 70.8 (11.5) kg at baseline to 70.5 (0.4) kg at EOS; change in body weight from baseline [95% CI]: 0.3 kg [-0.59; 1.1], p=0.54. There was numerical reduction in number of patients reporting resource utilisation associated with diabetes & its complications (outpatient visits: 72 to 32 and workdays missed: 2 to 0). Patient-reported non-severe (47 to 8) and severe hypoglycaemic episodes (4 to 1) reduced as well. Conclusion: In real-world population of Indian adults with T2DM, initiation with or switch to IDegAsp improved glycaemic control, with numerically lower resource utilisations (outpatient visits and workdays missed) and patient-reported hypoglycaemia.