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

• Status: Completed
• Trial end date: 2003-10-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting; Isophane insulin, beef; Isophane Insulin, Human

Criteria

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