Flexible Dose of Insulin Degludec Noninferior to Insulin Glargine

San Diego—An open-label, randomized trial found that patients with type 2 diabetes who took insulin degludec in a flexible regimen had similar glycemic control, rates of hypoglycemia, insulin dose, and weight gain compared with patients who took insulin glargine at the same time each day according to the product’s labeling. The authors concluded that insulin degludec can be injected at different times each day and still not compromise glycemic control or safety. Results were presented at the ADA meeting in a late-breaking poster titled Flexible Once- Daily Dosing of Insulin Degludec Does Not Compromise Glycemic Control or Safety Compared to Insulin Glargine Given Once Daily at the Same Time Each Day in People with Type 2 Diabetes. The authors said that basal insulin should be injected at a consistent time, although patients typically have trouble adhering to a dosing schedule, which may lead to them not attaining recommended glycemic targets. They hypothesized that insulin degludec, an ultra-long-acting basal insulin, may allow for more flexible intervals. The study enrolled patients who were ≥18 years of age, had type 2 diabetes for ≥6 months, and took oral antidiabetics, basal insulin, or oral antidiabetics plus basal insulin before the trial. If they had taken oral antidiabetics, patients had to have a hemoglobin A1c (HbA1c) level between 7% and 11% to be included in the study. If they had taken basal insulin plus oral antidiabetics, they had to have an HbA1c level between 7% and 10%. Patients were randomized in a 1:1:1 ratio to receive one of the following regimens: a flexible dosing interval of insulin degludec between 8 and 40 hours with or without an oral antidiabetic (n=229); insulin degludec taken every night with dinner and with or without an oral antidiabetic (n=228); or insulin glargine taken every day according to its label with or without food (n=230). The groups had similar baseline characteristics. The mean HbA1c level was 8.4%, the mean fasting plasma glucose (FPG) level was 161 mg/dL, and the mean duration of diabetes was 10.6 years. Patients who were previously treated with oral antidiabetics continued on the same regimen during the trial. Insulin-naïve patients began the study taking 10 units of insulin degludec or insulin glargine. Patients who had taken basal insulin once daily before the trial and switched to basal insulin continued on the same unit dose. Those who had taken twice-daily basal insulin had their dosage reduced during the trial. The insulin dosage was adjusted weekly to a target FPG level <90 mg/dL. After 26 weeks, patients taking a flexible dosing of insulin degludec had a 1.28% reduction in HbA1c level compared with a 1.26% reduction in patients taking insulin glargine. There was no significant difference in HbA1c level between the flexible and strict insulin degludec dosing regimens. The mean FPG level at 26 weeks was 105 mg/dL in the flexible insulin degludec group, 105 mg/dL in the strict insulin degludec group, and 112 mg/dL in the insulin glargine group. Rates of hypoglycemia (defined as plasma glucose <56 mg/dL or severe) were similar among the groups: 3.6 episodes per patient-year in the flexible insulin degludec group, 3.6 in the strict insulin degludec group, and 3.5 in the insulin glargine group. In addition, rates of nocturnal confirmed hypoglycemia were similar: 0.6 episodes per patient-year in the flexible insulin degludec group, 0.6 in the strict insulin degludec group, and 0.8 in the insulin glargine group. This study was supported by Novo Nordisk.