New Study Showed Lantus(R) Plus One, Two or Three Shots of Apidra(R) Lowered Patients' B...( - Study Presented at 69th Annual ADA ...),Health

- Study Presented at 69th Annual ADA Scientific Sessions Examined Efficacy and Safety of Basal-Prandial Treatment with Lantus(R) and Apidra(R) -

NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. presented results of a new study, "Effects of 1, 2, or 3 Prandial Injections of Insulin Glulisine on Glycemic Control in Type 2 Diabetes Patients on Insulin Glargine and Oral Drugs," evaluating patients adding prandial insulin Apidra(R) (insulin glulisine [rDNA origin] injection) administered before 1 meal, 2 meals or 3 meals daily, already taking basal insulin, Lantus(R) (insulin glargine [rDNA origin] injection), with or without oral antidiabetic drugs (OADs).The study was presented as a poster during the 69th Annual Scientific Sessions of the American Diabetes Association (ADA).

The study was a multicenter, randomized, open-label, parallel group study in insulin naive patients. Lantus(R) was started for a 14-week run-in period, after which time patients not at goal (A1C<7%) at week 0 were randomized to a 24-week intensified regimen of Lantus(R) plus Apidra(R) administered as above. Dose was adjusted to achieve an A1C<7%, fasting plasma glucose (FPG) and preprandial blood glucose < 110 mg/dl, and bedtime blood glucose < 130 mg/dl. FPG, Lantus(R) dose, and weight did not differ significantly among the 3 arms. Overall incidence and severity of adverse events (AEs) were comparable among the 3 treatment arms. The most frequently reported AEs included upper respiratory tract infections (5.2%), peripheral edema (4.1%), pain in extremity (3.8%), nasopharyngitis (3.5%), sinusitis (3.2%), and back pain (3.2%). A greater but nonsignificant proportion of patients experienced serious and severe hypoglycemia with Apidra(R) 3 times daily compared with those receiving Apidra(R) once or twice daily. The rates of symptomatic or severe hypoglycemia were not statistically significant between groups.