Insulin Degludec Once-Daily in Type 2 Diabetes: Simple or Step-Wise Titration (BEGIN: Once Simple Use).

Introduction: Insulin degludec (IDeg) is a new basal insulin in development with a flat, ultra-long action profile that may permit dosing using a simplified titration algorithm with less frequent self-measured blood glucose (SMBG) measurements and more simplified titration steps than currently available basal insulins. Methods: This 26-week, multi-center, open-label, randomized, treat-to-target study compared the efficacy and safety of IDeg administered once-daily in combination with metformin in insulin-naïve subjects with type 2 diabetes using two different patient-driven titration algorithms: a 'Simple' algorithm, with dose adjustments based on one pre-breakfast SMBG measurement ( n = 111) versus a 'Step-wise' algorithm, with adjustments based on three consecutive pre-breakfast SMBG values ( n = 111). IDeg was administered using the FlexTouch insulin pen (Novo Nordisk A/S, Bagsværd, Denmark), with once-weekly dose titration in both groups. Results: Glycosylated hemoglobin (HbA) decreased from baseline to week 26 in both groups (−1.09%, IDeg; −0.93%, IDeg). IDeg was non-inferior to IDeg in lowering HbA [estimated treatment difference (IDeg − IDeg): −0.16% points (−0.39; 0.07)]. Fasting plasma glucose was reduced (−3.27 mmol/L, IDeg; −2.68 mmol/L, IDeg) with no significant difference between groups. Rates of confirmed hypoglycemia [1.60, IDeg; 1.17, IDeg events/patient year of exposure (PYE)] and nocturnal confirmed hypoglycemia (0.21, IDeg; 0.10, IDeg events/PYE) were low, with no significant differences between groups. Daily insulin dose after 26 weeks was 0.61 U/kg (IDeg) and 0.50 U/kg (IDeg). No significant difference in weight change was seen between groups by week 26 (+1.6 kg, IDeg; +1.1 kg, IDeg), and there were no clinically relevant differences in adverse event profiles. Conclusion: IDeg was effective and well tolerated using either the Simple or Step-wise titration algorithm. While selection of an algorithm must be based on individual patient characteristics and goals, the ability to attain good glycemic control using a simplified titration algorithm may enable patient empowerment through self-titration, improved convenience, and reduced costs. [ABSTRACT FROM AUTHOR]