T_Dia
03-18-2008, 06:07 PM
Novo Nordisk (NYSE: NVO) today announced that the U.S. Food and Drug Administration has approved NovoLog? (insulin aspart [rDNA origin] injection) for continuous subcutaneous insulin infusion (CSII) by external insulin pump in pediatric patients between the ages of 4 and 18 years. NovoLog? is the first and only insulin analog approved for this use.
Data from a trial published in the February issue of Diabetes Care in support of this approval demonstrated that compared to insulin lispro CSII, NovoLog? CSII achieved similar levels of glycemic control and safety. Results came from a 16-week, open-label, multi-center, parallel group study of 298 patients (aspart, n= 198; lispro, n = 100) (aged 4-18 years; type 1 diabetes duration greater than or equal to 1 year; CSII therapy treatment greater than or equal to 3 months; A1C less than or equal to 10% at screening).
"The approval of NovoLog? in insulin pumps for the pediatric population highlights the safety and efficacy of NovoLog? and underscores Novo Nordisk's commitment to providing treatments that benefit this sometimes overlooked segment of the diabetes population," said Alan C. Moses, M.D., vice president, chief medical officer worldwide.
About the Study
Patients in the study were randomized 2:1 to NovoLog? CSII or insulin lispro CSII via external pump with changes in reservoir, infusion set and infusion site at least once every 48 hours. Patients were stratified by age (3-5, 6-11 and 12-18 years) prior to randomization to ensure that both treatment groups had a similar proportion of young children, children and adolescents. By study end:
-- Both treatments resulted in comparable changes in baseline in A1C.
Nearly 60% of NovoLog? patients (versus 43.8% of insulin lispro patients)
achieved age-specific A1C goals, defined by the American Diabetes
Association as < 8.5% for subjects aged < 6 years and < 8% for subjects
aged 6-18 years
-- Weight-adjusted mean daily dose of NovoLog? (0.86 unit/kg) was
significantly less than that of insulin lispro (0.94 unit/kg) (P=0.018)
-- Rates of hypoglycemia and numbers and types of adverse events were
similar between both treatment groups
"NovoLog? CSII was shown to be safe and tolerable in pediatric subjects between the ages of 4 and 18 years old," said Dr. Stuart A. Weinzimer, lead study author. "The results of this study confirm that NovoLog? CSII therapy is efficacious in appropriately selected children and adolescents."
Full Article (http://money.cnn.com/news/newsfeeds/articles/marketwire/0375988.htm).
Data from a trial published in the February issue of Diabetes Care in support of this approval demonstrated that compared to insulin lispro CSII, NovoLog? CSII achieved similar levels of glycemic control and safety. Results came from a 16-week, open-label, multi-center, parallel group study of 298 patients (aspart, n= 198; lispro, n = 100) (aged 4-18 years; type 1 diabetes duration greater than or equal to 1 year; CSII therapy treatment greater than or equal to 3 months; A1C less than or equal to 10% at screening).
"The approval of NovoLog? in insulin pumps for the pediatric population highlights the safety and efficacy of NovoLog? and underscores Novo Nordisk's commitment to providing treatments that benefit this sometimes overlooked segment of the diabetes population," said Alan C. Moses, M.D., vice president, chief medical officer worldwide.
About the Study
Patients in the study were randomized 2:1 to NovoLog? CSII or insulin lispro CSII via external pump with changes in reservoir, infusion set and infusion site at least once every 48 hours. Patients were stratified by age (3-5, 6-11 and 12-18 years) prior to randomization to ensure that both treatment groups had a similar proportion of young children, children and adolescents. By study end:
-- Both treatments resulted in comparable changes in baseline in A1C.
Nearly 60% of NovoLog? patients (versus 43.8% of insulin lispro patients)
achieved age-specific A1C goals, defined by the American Diabetes
Association as < 8.5% for subjects aged < 6 years and < 8% for subjects
aged 6-18 years
-- Weight-adjusted mean daily dose of NovoLog? (0.86 unit/kg) was
significantly less than that of insulin lispro (0.94 unit/kg) (P=0.018)
-- Rates of hypoglycemia and numbers and types of adverse events were
similar between both treatment groups
"NovoLog? CSII was shown to be safe and tolerable in pediatric subjects between the ages of 4 and 18 years old," said Dr. Stuart A. Weinzimer, lead study author. "The results of this study confirm that NovoLog? CSII therapy is efficacious in appropriately selected children and adolescents."
Full Article (http://money.cnn.com/news/newsfeeds/articles/marketwire/0375988.htm).