LANTUS(Insulin glargine [rDNA origin])

LANTUS (Insulin glargine [rDNA origin]) is a long-acting insulin approved for once-daily subcutaneous administration. It is indicated for the treatment of adult and pediatric patients with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus who require basal insulin for hyperglycemia control. The drug was sponsored by Sanofi-aventis and received approval on April 25, 2007, under Application Number NDA 21-081/S-024.

Clinical studies evaluated the efficacy of LANTUS. In Study A, the HbA1c endstudy mean was 8.13, with an adjusted mean change from baseline of +0.21. Fasting blood glucose endstudy mean in Study A was 146.3 mg/dL, with an adjusted mean change from baseline of -21.1 mg/dL. In Study B, the HbA1c endstudy mean was 7.55, with an adjusted mean change from baseline of -0.16. Study C showed an HbA1c endstudy mean of 7.53, with an adjusted mean change from baseline of -0.07.

Safety findings include an incidence of treatment-emergent injection site pain of 2.7% for LANTUS, compared to 0.7% for the comparator (NPH human insulin). The discontinuation rate due to lack of efficacy in the LANTUS-breakfast arm of Study G was 5%. Medication errors involving LANTUS were reported in 9 cases.