Positive Phase III Results Reported for Investigational Insulin
U300 is noninferior to insulin glargine (December 3)
In a phase III study, 23% fewer diabetic subjects treated with an investigational insulin product (U300, Sanofi) experienced nocturnal hypoglycemia compared with subjects treated with Lantus (insulin glargine [rDNA origin] injection, Sanofi-Aventis). The new results were presented Dec. 3 at the International Diabetes Federation 2013 World Diabetes Congress in Melbourne, Australia.
The EDITION II trial included subjects with type-2 diabetes who had failed to control their blood sugar levels with basal insulin and oral medication, and who had a long duration of disease and a high body mass index (BMI). A total of 811 subjects were randomly assigned to receive U300 (n = 404) or Lantus (n = 407) once daily in the evening while continuing oral antidiabetic treatment.
The study met its primary endpoint by showing similar reductions in hemoglobin A1c (HbA1c) from baseline between U300 and Lantus at 6 months (least squares mean change: –0.57% and –0.56% , respectively) in subjects with type-2 diabetes who had challenging baseline characteristics (mean age of study participants: 58.2 years; duration of type-2 diabetes: 12.6 years; BMI: 34.8 kg/m2; HbA1c: 8.24%; and basal insulin dose: 0.67 U/kg at baseline).
The percentage of subjects with severe or confirmed (defined by plasma glucose level ≤ 70 mg/dL) nocturnal hypoglycemia from month 3 to month 6 was significantly lower with U300 compared with Lantus (21.6% vs. 27.9%, respectively; relative risk (RR): 0.77; P = 0.038). Over the 6-month treatment period, the incidence of any nocturnal hypoglycemia (the percentage of subjects with one or more events) was lower with U300 compared with Lantus (30.5% vs. 41.6%, respectively; RR: 0.73), as was the incidence of any hypoglycemic event at any time of the day (over a 24-hour period) (U300: 71.5%; Lantus: 79.3%; RR: 0.90). This result was also achieved across the entire 6-month study period, including the first 8 weeks of the trial.
Source: Sanofi; December 3, 2013.