The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared to basal insulin once or twice daily plus pre-prandial insulin for 16 weeks in patients with type 1 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 1 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 40 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or basal plus pre-prandial insulin group. Duration of treatment includes 2-week screening period, 16-week treatment observation period and 1-week follow-up.
In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).