Initiation or switch to insulin degludec/insulin aspart in adults with type 2 diabetes in India: Results from a prospective, non-interventional, real-world study.

Aim: To investigate clinical outcomes in adults with type 2 diabetes (T2D) after insulin degludec/insulin aspart (IDegAsp) treatment in a real-world setting.

Methods: The 26 weeks study involved 1102 adults with T2D who were either initiated with or switched to IDegAsp according to local practice in six countries. It was an open-label, non-interventional study. The primary endpoint was the change in glycosylated haemoglobin (HbA1c) levels from baseline to the end of study (EOS).

Results: From India, 185 adults participated in this study with mean age of 58.1 (10.3) years and 14.4 (8.1) years of mean duration of T2D. Mean HbA1c decreased from 9.8% (1.8) at baseline to 8.2% (0.1) at the EOS; change in HbA1c from baseline [95% CI]: -1.6% (0.1) [-1.8; -1.4], P < 0.0001. There was a significant reduction in mean fasting plasma glucose (FPG) level 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 (4.3) mg/dl [-60.7; -43.7], P < 0.0001. There was a numerical reduction in resource utilization related to diabetes and its complications and hypoglycaemic episodes. From baseline to EOS, the participants with outpatient visits (72 to 32) and workdays missed (2 to 0) decreased. Additionally, the number of patient-reported non-severe hypoglycaemic (47 to 8) and severe hypoglycaemic (4 to 1) episodes decreased as well.

Conclusion: Initiation or switching to IDegAsp led to improvement in glycaemic control in real-world population of Indian adults with T2D. This was accompanied by a numerical reduction in resource utilization and patient-reported hypoglycaemia. Clinical trial registration: NCT04042441.