IDF21-0673 IDegAsp treatment in adults with type 2 diabetes in real-world practice: clinical outcomes by prior therapy subgroup

Background: Insulin degludec/insulin aspart (IDegAsp), a co-formulation providing basal and mealtime insulin, can be used for insulin initiation and intensification in people with type 2 diabetes (T2D). Aim: To explore clinical parameters in a real-world population of adults with T2D initiating or switching to IDegAsp according to prior anti-diabetic therapy. Method: A subgroup analysis of a 26-week open-label, non-interventional, prospective study (NCT04042441) conducted in Australia, India, Malaysia, Philippines, Saudi Arabia and South Africa. Data were obtained from 1102 adults with T2D initiating or switching to IDegAsp as per local clinical practice. Clinical parameters were assessed according to anti-diabetic therapy at baseline (oral antidiabetic drugs [OADs], basal insulin, basal–bolus insulin, premix insulin and GLP-1 RA ± insulin). Results: Of the 1102 patients in the full analysis set, 1057 contributed to the analysis by prior therapy subgroup. Of these patients, 35.1% were previously using OADs, 21.8% basal insulin, 21.9% premix insulin, 13% basal–bolus insulin and 8.2% GLP-1 RA ± insulin. Mean HbA1c (SD) at baseline was 10.2% (1.97) in OAD users, 9.7% (1.84) in basal insulin users, 9.4% (1.95) in premix insulin users, 9.3% (1.95) in basal–bolus insulin users and 9.2% (1.81) in GLP-1 RA ± insulin users. There was a significant reduction in HbA1c from baseline to end of study (EOS, first visit week 26–36) in the overall study population (primary endpoint, estimated difference: –1.4 [–1.51;–1.29]95%CI; p < 0.0001) and across all prior therapy subgroups (Table). There was a significant change from baseline to EOS in fasting plasma glucose across subgroups, except for the basal–bolus insulin subgroup. Body weight reduced significantly in the OAD, basal insulin and basal–bolus insulin subgroups. Change from baseline in total daily insulin dose was –5.9 units (U) (–8.94;–2.90)95%CI for prior premix insulin users (p=0.0002) and –13.8 U (–18.24;–9.27)95%CI for prior basal–bolus users (p<0.0001). Between the 4-week period prior to baseline and the 4-week period prior to EOS/discontinuation, incidence rates of non-severe hypoglycaemia decreased significantly in the OAD, basal and premix subgroups, and the incidence rate of nocturnal non-severe hypoglycaemia decreased significantly in the basal and premix insulin subgroups. Incidence rates of severe hypoglycaemia occurring within 26 weeks prior to baseline and 26 weeks prior to EOS were similar in the OAD subgroup; no cases were reported in the other subgroups during the study. Discussion: In a real-world population of adults with T2D, switching to IDegAsp was associated with improved glycaemic control in all prior therapy subgroups, with significantly lower rates of non-severe hypoglycaemia for prior OAD, basal insulin and premix insulin users, and lower total insulin dose for prior premix and basal-bolus insulin users.