Comparative Trial Between Insulin Glargine and NPH Insulin in Children and Adolescents With Type 1 Diabetes
- Edith Schober, MD1,
- Eugen Schoenle, MD2,
- Jacobus Van Dyk, MD3,
- Karin Wernicke-Panten, MD4 and
- the Pediatric Study Group of Insulin Glargine
- 1University Children’s Hospital, Vienna, Austria
- 2University Children’s Hospital, Zurich, Switzerland
- 3University of Pretoria, Pretoria Academic Hospital, Pretoria, South Africa
- 4Clinical Development, Aventis Pharma Deutschland, Frankfurt, Germany
Studies such as the Diabetes Control and Complications Trial have shown that, as in adult patients, intensive diabetes management in adolescent patients results in better glycemic control and delays the onset and slows the progression of vascular and neurological complications (1). However, a cross-sectional multinational study showed that less than one-third of the children and adolescents who underwent treatment for diabetes had adequate metabolic control (2). Providing a constant supply of basal insulin that mimics that of healthy individuals is an essential aspect of maintaining tight glycemic control in patients with type 1 diabetes. The traditional NPH insulin and ultralente basal insulin formulations do not provide a constant and reliable 24-h basal insulin supply because their duration of action is too short, and unwanted peaks of action in the night can cause nocturnal hypoglycemia (3). This is of particular relevance in children and adolescents, who are more prone to hypoglycemic episodes (4,5).
A new long-acting insulin analog has been developed using recombinant DNA technology. Insulin glargine differs from human insulin by the addition of two additional arginines on the COOH terminus of the B-chain and the replacement of an asparagine residue with glycine on the A-chain (6). The resulting molecule has a peakless, prolonged time-action profile and …











