Comparing Second-Generation Basal Insulin Analogs for Type 2 Diabetes
Basal insulin analogs provide longer duration of action, flatter action profiles, and less day-to-day variability than isophane insulin.
According to a study published in Diabetes Care, insulin glargine 300 units/mL (Gla-300) and insulin degludec 100 units/mL (IDeg-100) provided similar glycemic control improvements in insulin-naive patients with uncontrolled type 2 diabetes. In addition, both exhibited relatively low risk for hypoglycemia.
To compare efficacy and safety measures for these longer-acting, second-generation basal insulin analogs, researchers conducted an open-label, parallel-group, 24-week noninferiority study in which 929 insulin-naive patients with type 2 diabetes (mean age, 60.5 years) were randomly assigned to receive evening dosing of Gla-300 or IDeg-100. The study's primary efficacy and safety end points measured management of hemoglobin (Hb)A1c levels and incidence rates of hypoglycemia, respectively. Baseline characteristics were similar between groups.
Mean glycemic HbA1c levels at baseline were 8.7% for the Gla-300 group and 8.6% for the IDeg-100 group. By week 24, both groups had reduced HbA1c levels to an average of 7%, demonstrating noninferiority of either drug (P <.0001).
Both groups also achieved a similar proportion of participants who reached HbA1c levels of <7% without confirmed, documented hypoglycemia (≤70 mg/dL) at any time of day at 24 weeks; Gla-300 showed an incidence rate of 66.5%, compared with 69% for IDeg-100. Likewise, there was no significant difference between groups with regard to hypoglycemia incidence at the <54 mg/dL asymptomatic threshold over the study period. However, during the first 12 weeks, incidence and event rates of confirmed hypoglycemia were significantly lower in the Gla-300 group.
The researchers reported that both longer-acting basal insulins were properly titrated and that only one severe hypoglycemic event occurred during the 24 weeks. This patient, who was in the Gla-300 group, had skipped their evening meal and neglected to reduce their insulin dose after a prior nonsevere event.
Certain limitations were noted, such as an inability to assess outcomes over a longer timespan because of the study's relatively short duration.
“Given that there are more similarities than differences in efficacy and safety between these two second-generation basal insulin analogs,” wrote the researchers, “it is suggested that selection of which to use in clinical practice should be determined not just by the evaluation of clinical factors but mainly by practical factors such as access and cost.”
Rosenstock J, Cheng A, Ritzel R, et al. More similarities than differences testing insulin glargine 300 units/mL versus insulin degludec 100 units/mL in insulin-naive type 2 diabetes: The randomized head-to-head BRIGHT trial [published online August 27, 2018]. Diabetes Care. doi:10.2337/dc18-0559