Insulin degludec comparable to glargine in type 1 and 2 DM

June 27, 2011

Insulin degludec, an ultra-long-acting basal insulin, was not inferior to insulin glargine in 2 separate phase III trials in patients with type 1 or type 2 diabetes.

Insulin degludec, an ultra-long-acting basal insulin, was not inferior to insulin glargine in 2 separate phase III trials in patients with type 1 or type 2 diabetes.
     The insulins were comparable at lowering glycosylated hemoglobin (HbA1c), but degludec was associated with a 25% lower risk of nocturnal hypoglycemia than glargine.
     “Overall, insulin degludec demonstrates a good tolerability and safety profile,” said Simon Heller, MD, Professor of Clinical Diabetes at the University of Sheffield in Sheffield, UK, who reported the results for type 1 diabetes.
     Both trials were 52-week, randomized, open-label, treat-to-target studies; and in both studies, patients were randomly assigned to self-administer either insulin degludec once daily or insulin glargine once daily at the same time each day as specified in prescribing instructions. Patients in each study also took insulin aspart at mealtime.  Basal insulin was titrated to a target of <90 mg/dL fasting plasma glucose (FPG).
     In the first trial, designated BEGIN:BB T1 LONG, 629 patients with type 1 diabetes from 6 countries were randomly assigned to one of the insulins  on a 3:1 basis. At total of 472 were randomized to degludec, and 154 to glargine. Patients assigned to degludec took the drug in the morning and in the evening on alternating days. Patients assigned to glargine took it at the same time every day.
     The mean HbA1c was reduced from 7.7% at baseline to 7.3% in each trial arm at 1 year, meeting the endpoint of non-inferiority for degludec. Overall rates of confirmed hypoglycemia were similar between the groups, but the rate of nocturnal hypoglycemia was 25% lower in the degludec-treated patients (P=.021).
     Mean FPG was reduced by 23 mg/dL in the degludec group, compared with 25 mg/dL in the glargine group (difference not significant).
     In the second study (BEGIN:BB), 992 patients with type 2 diabetes from 12 countries were randomized to either evening degludec injections or glargine at the same time each day, with or without metformin and/or pioglitazone, and insulin aspart at mealtimes.
     As in the type 1 diabetes trial, the risk of nocturnal hypoglycemia was 25% lower with degludec than with glargine (P=.040). But in this trial, degludec was also associated with significantly lower overall risk of hypoglycemia-an 18% reduction in risk compared with glargine (P=.036).
     Mean FPG was reduced by 43 mg/dL in the degludec group and by 38 mg/dL in the glargine group (difference not significant).
     “This is not a fluke result: it shows up in 7 phase III registration trials for degludec, consistently favoring for degludec vs. glargine,” said Alan Garber, MD, Professor of Medicine at Baylor College of Medicine in Houston, Texas, who presented the data on the type 2 diabetes trial.