A review of flexibly timed once-daily insulin degludec

This review analyzed the safety and effectivity of flexibly timed insulin degludec treatment among both type I and type II diabetic patients.

Insulin therapy is often needed to restore normal blood glucose levels in both type I and type II diabetic patients. However, the rigid injection schedule necessary and the fear of hypoglycemia (dangerously low blood glucose levels) and treatment-related weight gain often lead to lack of patient adherence and ineffective glycemic control.

Current long-acting insulin analogues, such as insulin glargine (Lantus) and insulin detemir (Levemir), used to achieve constant basal insulin levels, require administration at the same time every day. Insulin degludec (Tresiba), a new ultra long-acting insulin, has been shown to be as effective as existing long acting insulin treatments, providing constant glucose regulation with a reduced risk of hypoglycemic events. Previous trials have suggested that the ultra-long lasting effect of insulin degludec may also allow for a more flexible administration schedule compared to existing treatments. This review evaluated the safety and effect of flexibly timed once-daily insulin degludec treatment.

To date, more than 2,899 diabetic patients have been randomized to receive insulin degludec treatment in various phase III clinical trials. A year-long trial of insulin degludec among type I diabetic patients confirmed similar HbA1c (an indicator of average blood glucose levels over the past 3 months) reductions in patients treated with degludec (showing an average HbA1c reduction of 0.40%) compared to those treated with glargine (showing an average HbA1c reduction of 0.39%), highlighting that treatment with insulin degludec is non-inferior to treatment with insulin glargine. A similar phase III trial among type II diabetics reached similar conclusions. The risk of nighttime (nocturnal) hypoglycemia however was significantly lower with insulin degludec treatment, showing a 36% risk reduction compared to insulin glargine use.

A recent study among type II diabetic patients compared insulin degludec administered on a flexible dosing schedule (ranging from 8 to 40 hours between daily injections), insulin glargine administered once daily at the same time, and insulin degludec administered once daily at the same time. Results demonstrated that both HbA1c levels and the rate of hypoglycemic events were similar between the three treatment groups, establishing that a flexible dosing regimen is both safe and effective with insulin degludec injections. Similar results were reported in a study examining flexible dosing among type I diabetics.

This review concluded that insulin degludec treatment appears to tolerate extreme variations in the timing of daily injections, without compromising patient safety or drug efficiency.

Both authors of this review have declared previously receiving funds from Novo-Nordisk, the developer and manufacturer of insulin degludec (Tresiba).