Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes

Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial

This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.

Inclusion Criteria:

• Type 1 diabetes
• Treatment with insulin for at least 6 months prior to inclusion
• HbA1c below or equal to 11.0 %
• Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion

Exclusion Criteria:

• The receipt of any investigational drug within one month prior to this trial
• Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
• Total daily insulin doses at least 1.80 IU/kg
• Treatment with oral hypoglycaemic agents
• Known or suspected allergy to trial product or related products