"Despite many advances in diabetes treatment over the years, predictability of insulin remains problematic, which impacts clinicians' ability to help patients reach blood glucose targets and minimize side effects like hypoglycemia and weight gain," said Mari-Anne Gall, M.D., medical director, diabetes global development, Novo Nordisk Pharmaceuticals, Inc. "This study demonstrates that we can continue to substantially improve insulin therapy."
Conventional therapies that are less predictable in their effect on blood glucose levels create day-to-day variability, leading to increased risk of hypoglycemia and hyperglycemia. Insulin detemir has a unique mode of prolonging insulin action due to its distinct chemical structure, which is associated with slow and stable absorption from the injection site. This results in blood glucose levels that are consistent with each dose and are less variable within patient, as demonstrated in several studies and confirmed by this new data.
"Study after study is demonstrating that insulin detemir may offer benefits over currently available insulin therapies," said Peter Aurup, M.D., vice president of drug development, Novo Nordisk Pharmaceuticals, Inc. "As clinicians continue to struggle to help patients achieve optimal control without life-altering side effects, this research underscores how insulin detemir may offer people with diabetes more confidence in controlling their condition."
Findings from study
The clinical trial examined insulin detemir and NPH in adolescents and children with type 1 diabetes being treated with a basal-bolus regimen. In the 26-week, multinational, open-label study, 347 patients were randomized to receive insulin detemir or NPH once or twice a day with NovoLog® (insulin aspart [rDNA origin] injection), a rapid-acting insulin analog used to improve blood glucose control after meals.
The study found that there was similar improvement in A1C values in the two groups, but lower fasting glucose levels with insulin detemir (8.44 vs. 9.58 mmol/L or 152 mg/dL vs. 172 mg/dL, p=0.022). Within subject variability in fasting plasma glucose was also lower in patients on insulin detemir than those on NPH (3.32 vs. 4.29 mmol/L or 60 mg/dL vs. 77 mg/dL, p<0.001). The risk of nighttime hypoglycemia was 36 percent lower with insulin detemir compared to NPH, and there was less weight gain observed in the insulin detemir group compared to the NPH group (0.2 kg/m2 vs. 0.7 kg/m2, respectively), according to the study.
The adverse events observed in the study were similar between the treatment groups.
About insulin detemir
Insulin detemir, under the brand name LevemirTM, was approved by the European Commission for marketing in the European Union for the treatment of diabetes in June 2004.
In the United States, Novo Nordisk received an approvable letter from the U.S. Food and Drug Administration (FDA) for insulin detemir in the fourth quarter of 2003.
Insulin detemir was developed to be administered in Novo Nordisk's advanced insulin delivery systems such as the FlexPen® prefilled syringe, which is designed for safety and simplicity.